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10.1
Reporting for Commercial Drugs: ADR reporting is based on the
Common Toxicity Criteria. Adverse reactions requiring submission
to NCCTG Operations Office must
also be reported to the local IRB.
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Unexpected
grade 4 - 5
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Increased
incidence of a known ADR1
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FDA Form 3500 to NCCTG within 5 days2
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X
|
X
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1.
Any increased incidence of a known ADR that has been reported
in the package insert or the literature, including adverse event
resulting from a drug overdose.
2.
Fax or mail:
Online
Research
First Street, SW
Rochester, MN 555555
Fax: 555-555-1111
10.2
Toxicities to be graded at each evaluation and pretreatment symptoms/conditions
to be evaluated at baseline per NCI CTC grading unless otherwise
stated:
Toxicity/Symptoms
|
Baseline
|
Each
Evaluation
|
Grading
scale
(if not CTC)
|
Nausea
|
X
|
X
|
|
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Vomiting
|
X
|
X
|
|
|
Neuro-cortical
|
X
|
X
|
|
|
Edema
|
X
|
X
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None,
mild, moderate, severe
|
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Ascites
|
X
|
X
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No
vs. yes
|
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Thromboembolic
phenomena
|
X
|
X
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No
vs. yes
|
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Pleural
effusion
|
X
|
X
|
No
vs. yes
|
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