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

51. 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

52. “I just have to create a few loose ends for other people to clear up, and then I can out of here.”

53. Write good SAE narratives Be concise but complete Include only the pertinent PMH and HPI Describe the event Describe the response Describe the outcome And say when each of those happened Look for and respond to queries promptly

54. Sample narrative A 83 year old female with a history of epilepsy was found seizing and was appropriately enrolled at 18:05 on 3/10/09. In the ED at 20:22 she was awake and conversant. At 21:10 she had another generalized seizure and was treated with lorazepam 2 mg IV with termination of her seizure at 21:14. Her phenytoin level subsequently was reported to be 5. At 21:25 she was given phenytoin 1 g IV. At admission at 22:50 she was again awake and conversant.

55. Sample narrative A 83 year old female with a history of epilepsy was found seizing and was appropriately enrolled at 18:05 on 3/10/09. No respiratory distress or hypoxia was noted in the ED. Pulse ox 97% at 22:00 before admission. On 3/11/09 at 16:00, she was noted to be short of breath with a pulse ox of 88% on room air. At 16:15 supplemental oxygen was administered at 4 LPM and pulse ox was 93%. Chest x-ray at 17:11 showed RLL infiltrate suggestive of aspiration. Respiratory distress increased and at 23:20 she was transferred to the ICU and endotracheally intubated.