The following case study is a paraphrase from "Good Clinical Practice. Standard Operating Procedures for Clinical Researchers" (Kolman, J., Meng, P. and Scott, G. editors; John Wiley and Sons publishers, 1998): “While a study subject and a relative were walking in town one day during the summer, a hanging flower basket fell on a study subjects head, resulting in the study subject falling down and becoming unconscious. The subject’s relative called for an ambulance. On arrival at a local hospital’s Emergency Department, in which the subject regained consciousness but could not recall the event, a x-ray revealed a fractured skull. The subject’s consciousness level at this point was deteriorating and after further tests a subdural hematoma was diagnosed, which was evacuated under general anesthesia. Postoperative recovery was uneventful and progressing well until day four, when the patient developed acute dyspnea (shortness of breath) at rest during visiting time. An emergency lung scan was performed that confirmed a diagnosis of pulmonary embolism. The study subject was anticoagulated and was eventually discharged from the hospital” 1. What is/are the AE/s in the case study? 2. Are there any AEs that are "serious"? If "yes", list them and state why they are serious. 3. What are your thoughts about the AE(s) being related to the study drug (NOTE: we do not know whether the subject is on active drug or placebo)?
The following case study is a paraphrase from "Good Clinical Practice. Standard Operating Procedures for Clinical Researchers" (Kolman, J., Meng, P. and Scott, G. editors; John Wiley and Sons publishers, 1998):
“While a study subject and a relative were walking in town one day during the summer, a hanging flower basket fell on a study subjects head, resulting in the study subject falling down and becoming unconscious. The subject’s relative called for an ambulance. On arrival at a local hospital’s Emergency Department, in which the subject regained consciousness but could not recall the event, a x-ray revealed a fractured skull. The subject’s consciousness level at this point was deteriorating and after further tests a subdural hematoma was diagnosed, which was evacuated under general anesthesia. Postoperative recovery was uneventful and progressing well until day four, when the patient developed acute dyspnea (shortness of breath) at rest during visiting time. An emergency lung scan was performed that confirmed a diagnosis of pulmonary embolism. The study subject was anticoagulated and was eventually discharged from the hospital”
1. What is/are the AE/s in the case study?
2. Are there any AEs that are "serious"? If "yes", list them and state why they are serious.
3. What are your thoughts about the AE(s) being related to the study drug (NOTE: we do not know whether the subject is on active drug or placebo)?
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