1. Bashi Ratterree, RN, BSN, CCRP
Nurse Coordinator, CHM OHSU Knight Cancer Institute Mail code: UHN73C

2. Adverse Events Reporting Exercise
A Phase II Trial of the Safety and Efficacy of Abc-001 for the Treatment of CoordinatorStressitis
2 yr trial
Abc mg tablet daily PO
30 subjects
Age > 18 years
Dx: occupation in research

3. Investigator’s Brochure Drug: Abc-001
Common side effects
Nausea
Vomiting
Diarrhea
Abdominal pain
Abnormal LFT’s
Rash
Low K+
Elevated QTc
Headaches
Serious reactions
Death
Respiratory distress
Severe neutropenia
Hepatitis
Excessive bleeding

4. History for Subject 507
41 year old female otherwise in good general health
Diagnosis of occupation in research
Medical hx: asthma, allergies
Complains of intermittent, mild headaches
No known drug allergies
Meds: Zyrtec, multi-vitamin, ibuprofen

5. Physical for Subject 507 Alert, oriented, NAD Normal physical exam
BP 110/70, HR 76

6. Exercise Questions to Keep in Mind
Is there an adverse event?
What is the severity?
What is the relationship to study drug?
Is it a serious adverse event?
Is it an unanticipated problem?
Does it need to be reported?
To whom do you report?

7. Serious Adverse Events
Death
Life-Threatening
Hospitalization (initial or prolonged)
Disability
Congenital Anomaly
Requires Intervention to Prevent Permanent Impairment or Damage
Results in psychological or emotional harm requiring treatment
Results in a significant medical incident

8. Unanticipated Problems – Remember: ‘Must fit all’
1. On Protocol
2. SAE
3. Unanticipated
4. Related or Possibly Related
Category 1
2. Anticipated AE or SAE
3. Related or Possibly Related
4. Occurring at a higher frequency or severity
Category 2
1. Unanticipated AE or SAE
2. Related or Possibly Related
3. May alter the risks and therefore warrants changes to the protocol, DSMP, or consent process
Category 3
1. Unanticipated
2. ‘Other’ events
3. May place subjects or others at greater risk of harm or discomfort. Harm need not have occurred.
Category 4
If event does not fit, it is not reportable.

9. Progress Note
1/3/10 Subject 507 in for study visit. Reports feeling her
usual self. Takes study drug regularly. No side effects reported. No change in concomitant medications.

10. Subject Diary 1/10/10 Anxiety attack had to miss work. Felt nervous
all day.
1/12/10 Feeling better.
Back at work.

11. Example of documentation of AE & Con Med#
Start date
Stop date
SAE UP
Grade
Attribution
DLT
Action
Therapy
Outcome 1
Anxiety attack
1/10/10
1/12/10 N 2
Unlikely No
None
Lorazepam
Recovered #
Start
_____
Stop
Agent or Procedure
Dose
______
Route
Schedule
_______________
Reason
If applicable, AE # 1
Jan/05
Lorazepam
1 mg
Q 4-6 hrs PRN
ongoing PO
Anxiety

12. Progress Note 1/22/10 Subject 507 in for study visit. Reports nausea
lasting 2 hours on 1/18/10.

13. Progress Note
1/27/10 Reports fractured ankle from falling off a horse.
Outpatient surgical repair with excessive bleeding that
required overnight hospitalization. Study drug held for 2
weeks. Vicodin added to concomitant medications.

14. Progress Note
2/2/10 Subject 507 in for study visit. Reports recovering
from ankle fracture. Complains of increased headaches. Doubled her use of ibuprofen, continues pain medication and no change in other meds. Headaches are so severe, subject could not go to work.
Vital signs: BP 170/95, HR 90

15. Progress Note 2/15/10 Subject 507 in for study visit. Reports cold
symptoms of runny nose and non-productive cough. Took
cold remedies for 2 days. Does not recall the medication
names, doses or dates taken.
Plan: Review the importance of keeping track of dates and
any concomitant medications while participating in a study.

16. Progress Note
2/20/10 Someone broke into your car and stole a few items … including the laptop on which you keep data for this study.

17. Progress Note 3/3/10 Subject 507 in for study visit. Reports stomach
ache about 30 minutes after taking study drug. Lasts 1
hour, does not require medication or interfere with her
usual activity.

18. Exercise Questions Is there an adverse event? What is the severity?
What is the relationship to study drug?
Is it a serious adverse event?
Is it an unanticipated problem?
Does it need to be reported?
To whom do you report?

19. Progress Note 3/15/10 Subject 507 in for study visit. Reports rapid
onset of intermittent blurred vision beginning 3/9/10
and lasting 3 days. Reports no other problems.
Continues study drug and no change in concomitant
medications.

20. Progress Note
4/15/10 Subject reports having horrible nightmares. According to her spouse, she is sleep walking and has become a danger to herself.
Subject is admitted to the sleep unit for overnight observation.

21. Questions? Comments?