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During the
weekly visits, adverse side effects must be documented. Adverse
side effects are defined as any untoward clinical symptom, sign,
or event. For instance, if the patient developed a headache and
took ibuprofen for relief, this should be documented as an adverse
event. All concomitant medications should be documented as well.
When documenting an adverse event assess the following:
- Onset and
cessation date;
- Frequency;
- Severity;
- Seriousness;
- Relation
to the study medication;
- Action
taken; and
- Outcome.
All serious
adverse events should be brought to the attention of the principal
investigator and addressed immediately. Serious adverse events
include any of the following:
- Death;
- Immediate
threatening of life; and
- Inpatient
hospitalization or prolongation of existing hospitalization;
persistent or significant disability/incapability and/or associated
with congenital abnormality, cancer, or overdose.
Again, all
data must correspond to the desired objectives as stated in the
primary and secondary endpoints. In this study, the WHO pain ladder
allows us to determine the severity and duration of mouth and
throat pain, and duration of narcotic use. The WHO and OMAS scales
allow us to determine the severity and duration of mucositis and
the patient's oral functioning.
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