Rio Salado College Documenting Adverse Events Activity
Description
Review the scenarios below and fill out the log using the information from the scenario, the CTCAE
Example: A patient was entered into a trial on November 20, 2020. Six days after taking the first dose of study medication, the patient was extremely sleepy and bloated after eating dinner. She took an OTC medication, TUMs, and went to sleep and felt better the next day, eating two slices of pumpkin pie for breakfast. See the log attached to view how this was documented.
Scenario 1:
A patient gave consent and was entered into a trial on October 16, 2021. The next morning the patient took the first dose of study medication and felt severely nauseated shortly afterward. She ate a light breakfast and coffee. The patient said she was violently sick about an hour later and vomited twice. She felt better a few hours later and continued to take her next study drug dose as scheduled. She did not have any more symptoms.
Scenario 2:
A participant is enrolled in a trial evaluating the safety and efficacy of a new investigational anti-inflammatory agent for osteoarthritis on September 20, 2020. He develops severe abdominal pain and nausea 30 days after randomization (enrollment). The PI advises the patient to see a gastroenterologist and the medical evaluation reveals gastric ulcers. He is prescribed Rabeprazole and will be seen again in 2-3 months for follow-up evaluation. The PI reviews the information and believes the patient should remain in the study but will re-evaluate after the follow-up evaluation with the GI.
Scenario 3:
A participant with seizures enrolled in a trial comparing a new investigational anti-seizure agent to a standard FDA-approved anti-seizure medication on August 10, 2019. One month after enrollment, the subject is hospitalized with severe fatigue, shortness of breath, and jaundice. The bloodwork confirms that the patient has immune-mediated hemolytic anemia and is scheduled for blood transfusion.
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