A study requires that each subject be given two study drugs. The first study drug is given on Day 1. A second study drug is given on Day 7 to counteract the toxidity of Drug 1. Subject $4706 is given Drug 1 on Day 1. Due to a snowstorm, Subject 4-706 is delayed for several days before returning to the site for Drug 2. Missing the administration of Drug 2 on Day 7 placed the subject at risk of significant toxicity. This event required the subject be notified of the increased risk and required close monitoring of the subject by phone.
This is an unanticlpated problem that does not include an adverse event.
This is not an unanticlpated problem because adverse weather is a possibility In the area where the site is located.
This is not an unanticlpated problem because the subject was required to return on Day 7.
This is an adverse event, which does not require notification to the IRB.
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