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Adverse Events and Serious Adverse Events

Adverse Events and Serious Adverse Events.

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Adverse Events and Serious Adverse Events

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  1. Adverse Events and Serious Adverse Events

  2. A 52 yo was found seizing and was appropriately enrolled . Her convulsions stop prior to ED arrival. After recovering from her post ictal state she complains of a severe headache. CT shows a subarachnoid hemorrhage. After diagnostic angiography she is admitted to the ICU to await surgery. 14 hours after admission her neurological condition deteriorates and repeat CT shows a massive re-bleed, which is fatal 2 hours later. Adverse event? Yes / No

  3. A 52 yo was found seizing and was appropriately enrolled . Her convulsions stop prior to ED arrival. After recovering from her post ictal state she complains of a severe headache. CT shows a subarachnoid hemorrhage. After diagnostic angiography she is admitted to the ICU to await surgery. 14 hours after admission her neurological condition deteriorates and repeat CT shows a massive re-bleed, which is fatal 2 hours later. Adverse event? Yes / No

  4. A 52 yo was found seizing and was appropriately enrolled . Her convulsions stop prior to ED arrival. After recovering from her post ictal state she complains of a severe headache. CT shows a subarachnoid hemorrhage. After diagnostic angiography she is admitted to the ICU to await surgery. 14 hours after admission her neurological condition deteriorates and repeat CT shows a massive re-bleed, which is fatal 2 hours later. Adverse event? Yes / No If yes, is it serious? Yes / No

  5. A 52 yo was found seizing and was appropriately enrolled . Her convulsions stop prior to ED arrival. After recovering from her post ictal state she complains of a severe headache. CT shows a subarachnoid hemorrhage. After diagnostic angiography she is admitted to the ICU to await surgery. 14 hours after admission her neurological condition deteriorates and repeat CT shows a massive re-bleed, which is fatal 2 hours later. Adverse event? Yes / No If yes, is it serious? Yes / No

  6. A 52 yo was found seizing and was appropriately enrolled . Her convulsions stop prior to ED arrival. After recovering from her post ictal state she complains of a severe headache. CT shows a subarachnoid hemorrhage. After diagnostic angiography she is admitted to the ICU to await surgery. 14 hours after admission her neurological condition deteriorates and repeat CT shows a massive re-bleed, which is fatal 2 hours later. Adverse event? Yes / No If yes, is it serious? Yes / No Expected? Yes / No

  7. A 52 yo was found seizing and was appropriately enrolled . Her convulsions stop prior to ED arrival. After recovering from her post ictal state she complains of a severe headache. CT shows a subarachnoid hemorrhage. After diagnostic angiography she is admitted to the ICU to await surgery. 14 hours after admission her neurological condition deteriorates and repeat CT shows a massive re-bleed, which is fatal 2 hours later. Adverse event? Yes / No If yes, is it serious? Yes / No Expected? Yes / No

  8. A 52 yo was found seizing and was appropriately enrolled . Her convulsions stop prior to ED arrival. After recovering from her post ictal state she complains of a severe headache. CT shows a subarachnoid hemorrhage. After diagnostic angiography she is admitted to the ICU to await surgery. 14 hours after admission her neurological condition deteriorates and repeat CT shows a massive re-bleed, which is fatal 2 hours later. Related to study? A. Not related B. Unlikely C. Possibly D. Probably E. Definitely

  9. A 52 yo was found seizing and was appropriately enrolled . Her convulsions stop prior to ED arrival. After recovering from her post ictal state she complains of a severe headache. CT shows a subarachnoid hemorrhage. After diagnostic angiography she is admitted to the ICU to await surgery. 14 hours after admission her neurological condition deteriorates and repeat CT shows a massive re-bleed, which is fatal 2 hours later. Related to study? A. Not related B. Unlikely C. Possibly D. Probably E. Definitely

  10. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the patient becomes more alert and 15 minutes after arrival the nasal trumpet is removed. Adverse event? Yes / No

  11. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the patient becomes more alert and 15 minutes after arrival the nasal trumpet is removed. Adverse event? Yes / No

  12. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the patient becomes more alert and 15 minutes after arrival the nasal trumpet is removed. Adverse event? Yes / No If yes, is it serious? Yes / No

  13. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the patient becomes more alert and 15 minutes after arrival the nasal trumpet is removed. Adverse event? Yes / No If yes, is it serious? Yes / No

  14. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the patient becomes more alert and 15 minutes after arrival the nasal trumpet is removed. Adverse event? Yes / No If yes, is it serious? Yes / No Expected? Yes / No

  15. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the patient becomes more alert and 15 minutes after arrival the nasal trumpet is removed. Adverse event? Yes / No If yes, is it serious? Yes / No Expected? Yes / No

  16. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the patient becomes more alert and 15 minutes after arrival the nasal trumpet is removed. Related to study? A. Not related B. Unlikely C. Possibly D. Probably E. Definitely

  17. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the patient becomes more alert and 15 minutes after arrival the nasal trumpet is removed. Related to study? A. Not related B. Unlikely C. Possibly D. Probably E. Definitely

  18. Let’s change it around a bit…. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the respiratory depression worsens and endotracheal intubation is performed. Adverse event? Yes / No

  19. Let’s change it around a bit…. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the respiratory depression worsens and endotracheal intubation is performed. Adverse event? Yes / No

  20. Let’s change it around a bit…. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the respiratory depression worsens and endotracheal intubation is performed. Adverse event? Yes / No If yes, is it serious? Yes / No

  21. Let’s change it around a bit…. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the respiratory depression worsens and endotracheal intubation is performed. Adverse event? Yes / No If yes, is it serious? Yes / No

  22. Let’s change it around a bit…. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the respiratory depression worsens and endotracheal intubation is performed. Adverse event? Yes / No If yes, is it serious? Yes / No Expected? Yes / No

  23. Let’s change it around a bit…. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the respiratory depression worsens and endotracheal intubation is performed. Adverse event? Yes / No If yes, is it serious? Yes / No Expected? Yes / No

  24. Let’s change it around a bit…. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the respiratory depression worsens and endotracheal intubation is performed. Related to study? A. Not related B. Unlikely C. Possibly D. Probably E. Definitely

  25. Let’s change it around a bit…. A 14 yo with epilepsy was found seizing and was appropriately enrolled . En route to the ED he stops convulsing, but remains unresponsive. His respirations are shallow and he making some snoring noises. EMS places a nasopharyngeal airway. In the ED the respiratory depression worsens and endotracheal intubation is performed. Related to study? A. Not related B. Unlikely C. Possibly D. Probably E. Definitely

  26. Continuing with the same case…. After the 14 yo is endotracheally intubated, he begins convulsing again. He is treated with IV Keppra, and then a propofol drip and is admitted to the ICU for continuous EEG monitoring. Adverse event? Yes / No

  27. Continuing with the same case…. After the 14 yo is endotracheally intubated, he begins convulsing again. He is treated with IV Keppra, and then a propofol drip and is admitted to the ICU for continuous EEG monitoring. Adverse event? Yes / No

  28. Continuing with the same case…. After the 14 yo is endotracheally intubated, he begins convulsing again. He is treated with IV Keppra, and then a propofol drip and is admitted to the ICU for continuous EEG monitoring. Adverse event? Yes / No If yes, is it serious? Yes / No

  29. Continuing with the same case…. After the 14 yo is endotracheally intubated, he begins convulsing again. He is treated with IV Keppra, and then a propofol drip and is admitted to the ICU for continuous EEG monitoring. Adverse event? Yes / No If yes, is it serious? Yes / No

  30. Continuing with the same case…. After the 14 yo is endotracheally intubated, he begins convulsing again. He is treated with IV Keppra, and then a propofol drip and is admitted to the ICU for continuous EEG monitoring. Adverse event? Yes / No If yes, is it serious? Yes / No Expected? Yes / No

  31. Continuing with the same case…. After the 14 yo is endotracheally intubated, he begins convulsing again. He is treated with IV Keppra, and then a propofol drip and is admitted to the ICU for continuous EEG monitoring. Adverse event? Yes / No If yes, is it serious? Yes / No Expected? Yes / No

  32. Continuing with the same case…. After the 14 yo is endotracheally intubated, he begins convulsing again. He is treated with IV Keppra, and then a propofol drip and is admitted to the ICU for continuous EEG monitoring. Related to study? A. Not related B. Unlikely C. Possibly D. Probably E. Definitely

  33. Continuing with the same case…. After the 14 yo is endotracheally intubated, he begins convulsing again. He is treated with IV Keppra, and then a propofol drip and is admitted to the ICU for continuous EEG monitoring. Related to study? A. Not related B. Unlikely C. Possibly D. Probably E. Definitely

  34. A 24 yo is appropriately enrolled. Her convulsions stop prior to ED arrival. While in the ED she complains of mild to moderate nausea, but declines an antiemetic when it is offered to her. Adverse event? Yes / No

  35. A 24 yo is appropriately enrolled. Her convulsions stop prior to ED arrival. While in the ED she complains of mild to moderate nausea, but declines an antiemetic when it is offered to her. Adverse event? Yes / No

  36. Ok, let’s change it just a little…. A 24 yo is appropriately enrolled. Her convulsions stop prior to ED arrival. While in the ED she complains of mild to moderate nausea and is treated with Zofran, after which her nausea resolves. Adverse event? Yes / No

  37. Ok, let’s change it just a little…. A 24 yo is appropriately enrolled. Her convulsions stop prior to ED arrival. While in the ED she complains of mild to moderate nausea and is treated with Zofran, after which her nausea resolves. Adverse event? Yes / No

  38. Ok, let’s change it just a little…. A 24 yo is appropriately enrolled. Her convulsions stop prior to ED arrival. While in the ED she complains of mild to moderate nausea and is treated with Zofran, after which her nausea resolves. Adverse event? Yes / No If yes, is it serious? Yes / No

  39. Ok, let’s change it just a little…. A 24 yo is appropriately enrolled. Her convulsions stop prior to ED arrival. While in the ED she complains of mild to moderate nausea and is treated with Zofran, after which her nausea resolves. Adverse event? Yes / No If yes, is it serious? Yes / No

  40. Ok, let’s change it just a little…. A 24 yo is appropriately enrolled. Her convulsions stop prior to ED arrival. While in the ED she complains of mild to moderate nausea and is treated with Zofran, after which her nausea resolves. Adverse event? Yes / No If yes, is it serious? Yes / No Expected? Yes / No

  41. Ok, let’s change it just a little…. A 24 yo is appropriately enrolled. Her convulsions stop prior to ED arrival. While in the ED she complains of mild to moderate nausea and is treated with Zofran, after which her nausea resolves. Adverse event? Yes / No If yes, is it serious? Yes / No Expected? Yes / No

  42. Ok, let’s change it just a little…. A 24 yo is appropriately enrolled. Her convulsions stop prior to ED arrival. While in the ED she complains of mild to moderate nausea and is treated with Zofran, after which her nausea resolves. Related to study? A. Not related B. Unlikely C. Possibly D. Probably E. Definitely

  43. Ok, let’s change it just a little…. A 24 yo is appropriately enrolled. Her convulsions stop prior to ED arrival. While in the ED she complains of mild to moderate nausea and is treated with Zofran, after which her nausea resolves. Related to study? A. Not related B. Unlikely C. Possibly D. Probably E. Definitely

  44. Following along with this same 24 yo a little longer… She is diagnosed with fluoxetine over-dose, is loaded with 1g phenytoin, and is admitted to the hospital. 16 hours later (20 hours after ED arrival) she has another generalized seizure which spontaneously stops after 3 minutes. Her doctor orders another 0.5g phenytoin. Adverse event? Yes / No

  45. Following along with this same 24 yo a little longer… She is diagnosed with fluoxetine over-dose, is loaded with 1g phenytoin, and is admitted to the hospital. 16 hours later (20 hours after ED arrival) she has another generalized seizure which spontaneously stops after 3 minutes. Her doctor orders another 0.5g phenytoin. Adverse event? Yes / No

  46. Following along with this same 24 yo a little longer… She is diagnosed with fluoxetine over-dose, is loaded with 1g phenytoin, and is admitted to the hospital. 16 hours later (20 hours after ED arrival) she has another generalized seizure which spontaneously stops after 3 minutes. Her doctor orders another 0.5g phenytoin. Adverse event? Yes / No If yes, is it serious? Yes / No

  47. Following along with this same 24 yo a little longer… She is diagnosed with fluoxetine over-dose, is loaded with 1g phenytoin, and is admitted to the hospital. 16 hours later (20 hours after ED arrival) she has another generalized seizure which spontaneously stops after 3 minutes. Her doctor orders another 0.5g phenytoin. Adverse event? Yes / No If yes, is it serious? Yes / No

  48. Following along with this same 24 yo a little longer… She is diagnosed with fluoxetine over-dose, is loaded with 1g phenytoin, and is admitted to the hospital. 16 hours later (20 hours after ED arrival) she has another generalized seizure which spontaneously stops after 3 minutes. Her doctor orders another 0.5g phenytoin. Adverse event? Yes / No If yes, is it serious? Yes / No Expected? Yes / No

  49. Following along with this same 24 yo a little longer… She is diagnosed with fluoxetine over-dose, is loaded with 1g phenytoin, and is admitted to the hospital. 16 hours later (20 hours after ED arrival) she has another generalized seizure which spontaneously stops after 3 minutes. Her doctor orders another 0.5g phenytoin. Adverse event? Yes / No If yes, is it serious? Yes / No Expected? Yes / No

  50. Following along with this same 24 yo a little longer… She is diagnosed with fluoxetine over-dose, is loaded with 1g phenytoin, and is admitted to the hospital. 16 hours later (20 hours after ED arrival) she has another generalized seizure which spontaneously stops after 3 minutes. Her doctor orders another 0.5g phenytoin. Related to study? A. Not related B. Unlikely C. Possibly D. Probably E. Definitely

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