Adverse Events, COPD Exacerbations and Concurrent Illness and Medications Sample Clauses

Adverse Events, COPD Exacerbations and Concurrent Illness and Medications. Each adverse event, COPD exacerbation or concurrent illness that occurs during the study must be documented in the CRF, as outlined in Section 7. For any fractures that occur after the initiation of study drug, the location of the fracture and whether or not it is considered traumatic or non-traumatic must be recorded. A non-traumatic bone fracture will be defined as a fracture caused by a fall from less than a standing height. If there has been a change in the subject’s concurrent medication, this must be documented in the appropriate Concurrent Medications section of the CRF. The procedure for dealing with COPD exacerbations is described in Section 3.3.4 and Section 5.4.3.
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Related to Adverse Events, COPD Exacerbations and Concurrent Illness and Medications

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