Side effect adverse effect
[DOC File]SIGNIFICANT ADVERSE EVENT (SAE) REPORT
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If for med side effect or toxicity, explain: Was the pt/cg taught the side effects of the medication? Did the patient demonstrate understanding of teaching? Did the pt/cg report this side effect to the clinician? Was physician notified appropriately? IE = Insufficient evidence documented to make decision/not documented ADVERSE EVENT OUTCOME REPORT-
[DOC File]ADVERSE EVENT OUTCOME REPORT - NAHC
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Serious Adverse Experience Any experience that suggests a significant hazard, contra-indication, side effect or precaution. Side Effects Any actions or effects of a drug or treatment other than the intended effect. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems.
Ocular Side Effects of Systemic Drugs
If for med side effect or toxicity, explain: Was the pt/cg taught the side effects of the medication? Did the patient demonstrate understanding of teaching? Did the pt/cg report this side effect to the clinician? Was physician notified appropriately? IE = Insufficient evidence documented to make decision/not documented ADVERSE EVENT OUTCOME REPORT-
[DOC File]Possible Side Effects of FOLFOX (Leucovorin, 5 ...
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The Adverse Event may or may not have been contemplated and listed as side effect in the Informed Consent document. Expected Adverse Events - Adverse events described in the Package Insert on FDA approved drugs, biologics or devices; adverse events described in the FDA Investigator's Brochure/Device Description for investigational drugs ...
Difference Between Side Effect and Adverse Effect
Nov 14, 2016 · Possible Side Effects of FOLFIRINOX (Leucovorin, 5-Fluorouracil, Irinotecan, and Oxaliplatin) (Table Version Date: November 14, 2016) COMMON, SOME MAY BE SERIOUS In 100 people receiving FOLFIRINOX (Leucovorin, 5-Fluorouracil, Irinotecan, and Oxaliplatin), more than 20 and up to 100 may have:
[DOC File]ADVERSE OR UNANTICIPATED EVENTS
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Ocular side effects include meibomian gland dysfunction and atrophy, blepharoconjunctivitis, corneal opacities, decreased dark adaptation, decreased tolerance to CL, decreased vision, increased tear osmolarity, keratitis, myopia, ocular discomfort, ocular sicca, photophobia, teratogenic ocular abnormalities, and possibly decreased color vision (reversible)
[DOC File]ADVERSE EVENT OUTCOME REPORT
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Indicate if this SAE is already mentioned as a possible side effect in the consent form. IMPORTANT: Indicate which events are new by highlighting in yellow or by (lightly) shading the applicable row(s). If the highlighting or shading is too dark, the text will be unreadable on copies made of the report.
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