Bashi Ratterree, RN, BSN, CCRP Nurse Coordinator, CHM OHSU Knight Cancer Institute Mail code: UHN73C 503-494-9982 ratterre@ohsu.edu

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-001 50 mg tablet daily PO 30 subjects Age > 18 years Dx: occupation in research

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

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

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

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?

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

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.

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.

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

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

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

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.

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

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.

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.

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.

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?

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.

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.

Questions? Comments?