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Adverse Events l DSMB

Adverse Events/ DSMB   Data Safety Monitoring Board: Data Safety Monitoring Board Summary 6/09  Next Meeting: December 2009   Adverse Events: 97202  l  97405  l  97106  l  91105  l  98308 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. For questions regarding this website, or to request a copy of a particular MedWatch AE/SAE form, please contact Sarah C. Hahne at (336) 716-5992 or at shahne@wfubmc.edu.  Archived Adverse Events for closed studies. 97202 – CoQ10, Fatigue, Breast cancer   Event Number  Date of Event Main event (brief description) Related to study drug? 1 10/18/04 Hospitalization for grade 4 febrile neutropenia No 2 11/25/04 Hospitalization for grade 3 febrile neutropenia No 3 02/17/05 Hospitalization following laparoscopy with bilateral salpingo-oophorectomy; diverticulitis No 4 03/15/05 Hospitalization for nausea/vomiting, febrile neutropenia, hypovolemia and dehydration No 5 03/22/05 Hospitalization for chemotherapy-induced pancytopenia, febrile neutropenia No 6 03/29/05 Hospitalization for grade 3 febrile neutropenia and diarrhea No 7 07/15/05 Hospitalization for chemotherapy-induced neutropenia with nausea/vomiting, and diarrhea No 8 08/15/05 Hospitalization for chills and fever No 9 10/11/05 Hospitalization for cellulites, fever, chills No 10 10/20/05 Hospitalization for neutropenic fever No 11 11/21/05 Patient seen in clinic for vomiting, dehydration, pain; grade 4 leucopenia, grade 4 neutropenia No 12 12/05/05 Hospitalization for dehydration, nausea No 13 12/12/05 Hospitalization for shortness of breath; grade 4 vascular event No 14 12/13/05 Hospitalization for grade 4 infection No 15 12/15/05 Hospitalization for syncopal episode No 16 12/19/05 Labs revealed grade 4 decreased ANC No 17 12/21/05 Hospitalization for fatigue and syncope No 18 12/24/05 Hospitalization for dehydration, fatigue, nausea, vomiting No 19 01/02/06 Hospitalization for grade 3 diarrhea No 20 01/05/06 Hospitalization for thrombus No 21 01/16/06 Hospitalization for grade 1 fever and possible sepsis No 22 02/27/06 Hospitalization for grade 2 nausea, vomiting, and dehydration. No 23 03/27/06 Hospitalization for grade 3 catheter infection, nausea/vomiting, and headache No 24 04/04/06 Hospitalization for grade 2 DVT No 25 02/20/06 Hospitalization for dehydration, possible hypotension, tachycardia, swelling No 26 05/16/06 Hospitalization for grade 3 constipation No June 2006 27 04/22/06 Hospitalization for  grade 2 hematuria and hydonephroasis No August 2006 28 08/18/06 Hospitalization due to grade 3 shortness of breath and syncope No October 2006 29 10/17/06 Hospitalization due to grade 4 neutropenia No November 2006 30 11/09/06 Hospitalization due to grade 3 diarrhea and dehydration No 31 11/14/06 Hospitalization due to grade 3 anemia and neutropenia No January 2007 32 12/06/06 Hospitalization due to grade 3 diarrhea and neutropenia No February 2007 33 12/08/06 Hospitalization due to infection No 34 01/31/07 Hospitalization due to grade 3 neutropenia No 35 02/04/07 Hospitalization due to grade 3 infection, fever and hydration No March 2007 36 03/01/07 Hospitalization due to grade 3 dehydration and diarrhea No May 2007 37 03/30/07 Hospitalization due to grade 4 neutropenia and grade 3 dehydration No June 2007 38 05/10/07 Hospitalization due to grade 2 dizziness and weakness, grade 3 fever, infection, leukocytes and neutropenia. No      July 2007 39 07/24/07 Hospitalization due to grade 3 dehydration  No August 2007 40 08/11/07 Hospitalization due to grade 2 muscle weakness No 41 11/22/05 Hospitalization due to appendicitis No September 2007 42 04/24/07 Hospitalization due to grade 3 cellulitis No 43 05/31/07 Hospitalization due grade 4 WBC and grade 4 ANC No 44 07/31/07 Hospitalization due to grade 3 neutropenic fever and grade 3 hypotensive No 45 08/18/07 Hospitalization due to grade 3 neutropenia and grade 3 colon infection No October 2007 46 09/29/07 Hospitalization due to grade 3 post-op liver resection ileus and grade 2 UTI No November 2007 47  09/08/07 Hospitalization due to grade 3 vomiting, pain and infection No September 2008 48 08/31/08 Hospitalization due to grade 2 fever No November 2008 49 11/07/08 Hospitalization due to grade 4 neutropenia and grade 3 dehydration No December 2008 50 12/19/08 Hospitalization due to grade 3 neutropenia No February 2009 51 01/05/2009 Hospitalization due to grade 3 vomiting, diarrhea and dehydration No August 2009 52 02/20/2009 Grade 4 neutropenia No 53 07/15/2009 Cardiomyopathy No September 2009 54 08/17/09 Hospitalization due to grade 3 mood alteration-anxiety No Back to top           97405 – Soy / Effexor   Event Number  Date of event Main event (brief description) Related to study drug?   November 2007   1 10/12/07 Hospitalization due to grade 4 abdominal pain No   2 12/19/07 Hospitalization due to grade 3 infection No   June 2008 3 11/05/07 Hospitalization due to grade 3 pain and GU obstruction No August 2008 4 01/08/08 Hospitalization due to knee replacement No May 2009 5 04/16/09 Grade 3 anxiety, fatigue and pain No August 2009 6 07/30/09 Hospitalization due to grade 3 pain No 7 09/02/07 Hospitalization due to grade 3 pain No Back to top 97106  - ArginMax Event number Date of event Main event (brief description) Related to study drug? January 2008 1 11/29/07 Grade 3 stomach pain No 2 03/17/08 Hospitalization due to grade 3 Vulva abscess No August 2008 3 08/15/08 Grade 3 hyperglycemia No May 2009 4 01/21/08 Grade 3 night sweats and insomnia Possible Back to top     91105 - Donepezil Event number Date of event Main event (brief description) Related to study drug? August 2008 1 08/03/08 Hospitalization due to grade 3 confusion and cognitive disturbance No 2 08/15/08 Death, Grade 3 confusion and cognitive disturbance No September 2008 3 09/08/08 Hospitalization due to grade 3 syncope No June 2009 4 03/26/09 Grade 3 insomnia Probable August 2009 5 07/29/09 Grade 3 insomnia and headaches Probable September 2009 6 07/07/09 Grade 3 mood alteration No Back to top     98308 COLD-fX Event number Date of event Main event (brief description) Related to study drug? December 2008 1 12/03/08 Hospitalization due to grade 3 abdominal pain No 2 12/25/08 Hospitalization due to grade 3 pneumonia No January 2009 3 01/02/09 Hospitalized due to grade 4 dyspnea and grade 3 diastolic dysfunction No 4 01/04/09 Grade 3 stomach pain and grade 3 vomiting No 5 01/05/09 Hospitalization due to grade 3 pain No 6 01/12/09 Grade 3 hypertension No 7 01/12/09 Hospitalization due to grade 3 dyspnea No 8 01/16/09 Hospitalization due to grade 3 hemorrhage, pain and dyspnea (amended: grade 3 infection) No February 2009 9 11/18/08 Hospitalization due to transurethral hypertrophy No 10 12/29/08 Grade 3 urinary frequency Possibly 11 01/20/09 Grade 3 hyperglycemia No 12 01/20/09 Hospitalization due to grade 3 cardiac ischemia/infarction No 13 01/27/09 Grade 3 hemolysis Possibly 14 02/03/09 Hospitalization due to spleen abscess No 15 02/04/09 Prostate biopsy revealing low risk prostate cancer No 16 02/11/09 Hospitalization due to grade 3 dyspnea and low heart rate No March 2009 17 01/12/09 Hospitalization due to knee surgery No 18 01/23/09 Hospitalization due to grade 3 chest pain No 19 02/25/09 Hospitalization due to grade 2 chest pain No 20 03/16/09 Hospitalization due to grade 4 seizures Addendum: Death due to encephalitis No April 2009 21 04/15/09 Hospitalization due to grade 3 syncope and lightheadedness No May 2009 22 04/21/09 Grade 3 thrombosis Unlikely 23 05/01/09 Grade 3 hyperglycemia No 24 05/04/09 Hospitalization due to grade 3 infection and ulceration No June 2009 25 05/08/09 Grade 3 pain, headache No July 2009 26 03/26/09 Grade 4 chest pain Unlikely 27 04/27/09 Grade 3 bronochospasm, wheezing and dyspnea Unlikely August 2009 28 03/09/09 Grade 3 glucose No 29 03/18/09 New cancer diagnosis No 30 04/08/09 Hospitalization due to planned lobectomy No September 2009 31 12/22/08 Hospitalization due to grade 2 colitis and grade 3 diarrhea No Back to top   CCCWFU CCOP Research Base Home  l  Protocols  l  Welcome  l  Patient Registration  l  Accruals    Annual Meeting  l  Results  l  Adverse Events  l  Newsletter    Quick Reference Guides  l  Links  l  Sites  l  Staff  l  Contact Us