Data Safety Monitoring Board:  DSMB Minutes June 2009  
Next Meeting: December 2009 

Adverse Events 

97202

97405

97106

91105

98308

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Included in the list below are all adverse events (AEs) and serious adverse events (SAEs) from the Wake Forest site and all participating site members. This page is updated the first Thursday of each month with new events received during the previous month. Sites should submit AEs/SAEs from other sites as well as those that occur locally, according to the policies and procedures of their IRB.

Individual AEs for open studies are posted in our Patient Registration System, CCRBIS.  After entering your user name and password, click on the "Information" link at the top left hand corner of the screen.  Each AE is located in the middle of page using the drop-down menu for specific protocols.  For questions regarding this web site  please contact Sarah C. Hahne at 336-716-5992 or at shahne@wfubmc.edu. 
 

Archived Adverse Events  for closed studies.

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97202 - CoQ10, Fatigue, Breast cancer  

Event Number	Date of Event	Main Event (brief description)	Related to study drug?
1	10/18/2004	Hospitalization for grade 4 febrile neutropenia	No
2	11/25/2004	Hospitalization for grade 3 febrile neutropenia	No
3	2/17/2005	Hospitalization following laparoscopy with bilateral salpingo-oophorectomy; diverticulitis	No
4	3/15/2005	Hospitalization for nausea/vomiting, febrile neutropenia, hypovolemia and dehydration	No
5	3/22/2005	Hospitalization for chemotherapy-induced pancytopenia, febrile neutropenia	No
6	3/29/2005	Hospitalization for grade 3 febrile neutropenia and diarrhea	No
7	7/15/2005	Hospitalization for chemotherapy-induced neutropenia with nausea/vomiting, and diarrhea	No
8	8/15/2005	Hospitalization for chills and fever	No
9	10/11/2005	Hospitalization for cellulites, fever, chills	No
10	10/20/2005	Hospitalization for neutropenic fever	No
11	11/21/2005	Patient seen in clinic for vomiting, dehydration, pain; grade 4 leucopenia, grade 4 neutropenia	No
12	12/5/2005	Hospitalization for dehydration, nausea	No
13	12/12/2005	Hospitalization for shortness of breath; grade 4 vascular event	No
14	12/13/2005	Hospitalization for grade 4 infection	No
15	12/15/2005	Hospitalization for syncopal episode	No
16	12/19/2005	Labs revealed grade 4 decreased ANC	No
17	12/21/2005	Hospitalization for fatigue and syncope	No
18	12/24/2005	Hospitalization for dehydration, fatigue, nausea, vomiting	No
19	1/2/2006	Hospitalization for grade 3 diarrhea	No
20	1/5/2006	Hospitalization for thrombus	No
21	1/16/2006	Hospitalization for grade 1 fever and possible sepsis	No
22	2/27/2006	Hospitalization for grade 2 nausea, vomiting, and dehydration.	No
23	3/27/2006	Hospitalization for grade 3 catheter infection, nausea/vomiting, and headache	No
24	4/4/2006	Hospitalization for grade 2 DVT	No
25	2/20/2006	Hospitalization for dehydration, possible hypotension, tachycardia, swelling	No
26	5/16/2006	Hospitalization for grade 3 constipation	No
Jun-06
27	4/22/2006	Hospitalization for  grade 2 hematuria and hydonephroasis	No
Aug-06
28	8/18/2006	Hospitalization due to grade 3 shortness of breath and syncope	No
Oct-06
29	10/17/2006	Hospitalization due to grade 4 neutropenia	No
Nov-06
30	11/9/2006	Hospitalization due to grade 3 diarrhea and dehydration	No
31	11/14/2006	Hospitalization due to grade 3 anemia and neutropenia	No
Jan-07
32	12/6/2006	Hospitalization due to grade 3 diarrhea and neutropenia	No
Feb-07
33	12/8/2006	Hospitalization due to infection	No
34	1/31/2007	Hospitalization due to grade 3 neutropenia	No
35	2/4/2007	Hospitalization due to grade 3 infection, fever and hydration	No
Mar-07
36	3/1/2007	Hospitalization due to grade 3 dehydration and diarrhea	No
May-07
37	3/30/2007	Hospitalization due to grade 4 neutropenia and grade 3 dehydration	No
Jun-07
38	5/10/2007	Hospitalization due to grade 2 dizziness and weakness, grade 3 fever, infection, leukocytes and neutropenia.	No
July-07
39	7/24/2007	Hospitalization due to grade 3 dehydration	No
Aug-07
40	8/11/2007	Hospitalization due to grade 2 muscle weakness	No
41	11/22/2005	Hospitalization due to appendicitis	No
Sep-07
42	4/24/2007	Hospitalization due to grade 3 cellulitis	No
43	5/31/2007	Hospitalization due grade 4 WBC and grade 4 ANC	No
44	7/31/2007	Hospitalization due to grade 3 neutropenic fever and grade 3 hypotensive	No
45	8/18/2007	Hospitalization due to grade 3 neutropenia and grade 3 colon infection	No
Oct-07
46	9/29/2007	Hospitalization due to grade 3 post-op liver resection ileus and grade 2 UTI	No
Nov-07
47	09/08/07	Hospitalization due to grade 3 vomiting, pain and infection	No
Sep-08
48	8/31/2008	Hospitalization due to grade 2 fever	No
Nov-08
49	11/7/2008	Hospitalization due to grade 4 neutropenia and grade 3 dehydration	No
Dec-08
50	12/19/2008	Hospitalization due to grade 3 neutropenia	No
Feb-09
51	1/5/2009	Hospitalization due to grade 3 vomiting, diarrhea and dehydration	No
Aug-09
52	2/20/2009	Grade 4 neutropenia	No
53	7/15/2009	Cardiomyopathy	No
Sept-09
54	8/17/2009	Hospitalization due to grade 3 mood alteration-anxiety	No

97405 – Soy/Effexor  

Event Number	Date of event	Main event (brief description)	Related to study drug?
Nov-07
1	10/12/2007	Hospitalization due to grade 4 abdominal pain	No
2	12/19/2007	Hospitalization due to grade 3 infection	No
Jun-08
3	11/5/2007	Hospitalization due to grade 3 pain and GU obstruction	No
Aug-08
4	1/8/2008	Hospitalization due to knee replacement	No
May-09
5	4/16/09	Grade 3 anxiety, fatigue and pain	No
Aug-09
6	7/30/09	Hospitalization due to grade 3 pain	No
7	9/02/07	Hospitalization due to grade 3 pain	No

97106 - ArginMax  

Event Number	Date of event	Main event (brief description)	Related to study drug?
Jan-08
1	11/29/2007	Grade 3 stomach pain	No
2	3/17/2008	Hospitalization due to grade 3 Vulva abscess	No
Aug-08
3	8/15/2008	Grade 3 hyperglycemia	No
May-09
4	1/21/08	Grade 3 night sweats and insomnia	Possible

91105 - Donepezil  

Event Number	Date of event	Main event (brief description)	Related to study drug?
Aug-08
1	8/3/2008	Hospitalization due to grade 3 confusion and cognitive disturbance	No
2	8/15/2008	Death, Grade 3 confusion and cognitive disturbance	No
Sep-08
3	9/8/2008	Hospitalization due to grade 3 syncope	No
June-09
4	03/26/2009	Grade 3 insomnia	Probable
Aug-09
5	7/29/2009	Grade 3 insomnia and headaches	Probable
Sept-09
6	7/7/2009	Grade 3 mood alteration	No
Oct-09
7	7/22/09	Hospitalization due to surgery	No
8	9/25/09	Hospitalization due to seizure	No
9	10/2/09	Death due to pulmonary embolus	No
10	10/22/09	Hospitalization due to grade 4 aspiration and grade 3 somnolence	Possible

98308 COLD-fX  

Event Number	Date of event	Main event	Related to study drug?
Dec-08
1	12/3/2008	Hospitalization due to grade 3 abdominal pain	No
2	12/25/2008	Hospitalization due to grade 3 pneumonia	No
Jan-09
3	1/2/2009	Hospitalized due to grade 4 dyspnea and grade 3 diastolic dysfunction	No
4	1/4/2009	Grade 3 stomach pain and grade 3 vomiting	No
5	1/5/2009	Hospitalization due to grade 3 pain	No
6	1/12/2009	Grade 3 hypertension	No
7	1/12/2009	Hospitalization due to grade 3 dyspnea	No
8	1/16/2009	Hospitalization due to grade 3 hemorrhage, pain and dyspnea	No
		(amended: grade 3 infection)
Feb-09
9	11/18/2008	Hospitalization due to transurethral hypertrophy	No
10	12/29/2008	Grade 3 urinary frequency	Possibly
11	1/20/2009	Grade 3 hyperglycemia	No
12	1/20/2009	Hospitalization due to grade 3 cardiac ischemia/infarction	No
13	1/27/2009	Grade 3 hemolysis	Possibly
14	2/3/2009	Hospitalization due to spleen abscess	No
15	2/4/2009	Prostate biopsy revealing low risk prostate cancer	No
16	2/11/2009	Hospitalization due to grade 3 dyspnea and low heart rate	No
Mar-09
17	1/12/2009	Hospitalization due to knee surgery	No
18	1/23/2009	Hospitalization due to grade 3 chest pain	No
19	2/25/2009	Hospitalization due to grade 2 chest pain	No
20	3/16/2009	Hospitalization due to grade 4 seizures Addendum: Death due to encephalitis	No
Apr-09
21	4/15/2009	Hospitalization due to grade 3 syncope and lightheadedness	No
May - 09
22	4/21/09	Grade 3 thrombosis	Unlikely
23	5/1/09	Grade 3 hyperglycemia	No
24	5/4/09	Hospitalization due to grade 3 infection and ulceration	No
June- 09
25	5/8/09	Grade 3 pain, headache	No
July-09
26	3/26/09	Grade 4 chest pain	Unlikely
27	4/27/09	Grade 3 bronchospasm, wheezing, and dyspnea	Unlikely
Aug-09
28	3/9/09	Grade 3 glucose	No
29	3/18/09	New cancer diagnosis	No
30	4/8/09	Hospitalization due to planned lobectomy	No
Sept-09
31	12/22/08	Hospitalization due to grade 2 colitis and grade 3 diarrhea	No
Oct-09
32	3/6/09	Grade 3 rash	No
33	4/24/09	Grade 3 URI	No
34	5/16/09	Hospitalization due to grade 4 hypercalcemia	No