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



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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)



Not Serious

Serious

  • Cough

  • Headache

  • Nausea

  • Tiredness (fatigue)

  • None

Less Likely

(Between 2-9 subjects out of 100)



Not Serious

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

  • 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

Serious

  • None

  • 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)

Rare but Serious

(Less than 5 subjects out of 100)

Likely and Not Serious

  • Nausea and vomiting

  • Abnormal levels of certain salts in the body like sodium and potassium


Likely and Serious

  • Fewer red blood cells and white blood cells and platelets in the blood

    • A low number of red blood cells can make you feel tired and weak.

    • A low number of white blood cells can make it easier to get infections.

    • A low number of platelets causes you to bruise and bleed more easily.



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)


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)

  • 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)

Less Likely

(5-20 subjects out of 100)

Rare but Serious

(Less than 5 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

    • A low number of red blood cells can make you feel tired and weak.

    • A low number of white blood cells can make it easier to get infections.

    • 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 high-pitched sounds

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




  • Allergic reactions, which may be severe and life-threatening (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)

Less Likely

(5-20 subjects out of 100)

Rare but Serious

(Less than 5 subjects out of 100)

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

    • A low number of white blood cells can make it easier to get infections.


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

  • 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

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”.

All Subjects










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

These risks are expected to occur in more than 20 out of 100 subjects.



  • Unusual breath and odor from DMSO (substance used to protect the cells during freezing)

  • Nausea

  • Vomiting

  • Facial flushing

  • Red colored urine

  • Hypertension

  • Bradycardia




Not serious

Serious

Less likely

These risks are expected to occur in 5-20 subjects or less out of 100 subjects.



  • Diarrhea

  • Headache

  • Fever

  • Chills

  • Hypothermia

  • Hypotension

  • Abdominal cramps

  • Shortness of breath

  • Chest tightness










Serious

Rare

These risks are expected to occur in less than 5 subjects out of 100






  • Bleeding

  • Allergic reactions

  • Heart rhythm disorder

  • Kidney failure

  • Infection

  • Engraft failure

Are all groups exposed to the risks listed above?


Yes


No


N/A (There is only one group)




If No, Describe: [Describe here]



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