Adverse Events/DSMB
Data Safety Monitoring Board: DSMB Minutes December 2011
Next Meeting: June 2012
Adverse Events
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@wakehealth.edu.
*Denotes addendum for clarification or resolution.
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 | 03/26/09 | Grade 3 insomnia | Probable |
| Aug-09 |
5 | 7/29/09 | Grade 3 insomnia and headaches | Probable |
| Sept-09 |
6 | 7/7/09 | 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 |
| Nov-09 |
11 | 11/01/09 | Death due to aspiration and infection | No |
| Mar-10 |
12 | 03/07/10 | Grade 3 vomiting and diarrhea | No |
| May-10 |
13 | 03/26/10 | Pain, Nausea, Vomiting, Infection - Grade 3, Lower gait walking - Grade 1 | No |
| June-10 |
14 | 04/27/10 | Hospitalization due to grade 3 nausea | No |
15 | 05/30/10 | Grade 3 muscule pain | No |
| Sept-10 |
16 | 06/18/10 | Grade 3 syncope event | No |
17 | 07/20/10 | Grade 3 pain | No |
| March-12 |
18 | 03/21/12 | Hospitalization due to grade 3 hernia | No |
Event number | Date of event | Main event | Related to study drug? |
| Mar-10 |
| 1 | 03/11/2010 | Hospitalization due to grade 3 neutropenic fever | No |
| Sept-10 |
| 2 | 08/27/2010 | Hospitalization due to grade 4 neutropenic fever and grade 3 acute kidney injury | No |
3 | 09/04/2010 | Hospitalization due to grade 3 Congestive Heart Failure | No |
Event number | Date of event | Main event | Related to study drug? |
| Sept-10 |
| 1 | 09/11/2010 | Hospitalization due to grade 4 agitation | No |
| Nov-10 |
| 2 | 11/19/2010 | Hospitalization due to grade 3 anemia and hematuria | No |
Dec-10 |
| 3 | 11/14/2010 | Hospitalization due to grade 3 diarrhea, nausea, vomiting, dehydration and grade 2 pain | No |
Feb-11 |
| 4 | 12/01/10 | Hypertension Grade 3, Sinus Tachycardia Grade 2 | No |
| 5 | 12/07/10 | Grade 3 Chest Pain, Grade 3 Headache, Grade 2 Nausea, Grade 3 Photophobia | Possibly |
| 6 | 01/01/11 | Hospitalization due to Fever Grade 1, Productive Cough Grade 2, Dyspnea Grade 1, Plenral Effusion Grade 2 | No |
Mar-11 |
| 7 | 01/11/11 | Hospitalization due to Grade 2 headache, siezure and fatigue. | Possibly |
April-11 |
| 8 | 03/30/11 | Grade 3 ALT and grade 1 AST | No |
May-11 |
| 9 | 03/21/11 | Hospitalization due to grade 3 muscle weakness and grade 2 lethargy | No |
| 10 | 04/12/11 | Grade 4 fatigue | No |
| 11 | 04/22/11 | Grade 5 due to tumor progression | No |
June-11 |
| 12 | 05/31/11 | Grade 5 due to tumor progression | No |
July-11 |
| 13 | 06/27/11 | Grade 5 due to disease | No |
| Nov-11 |
| 14 | 11/02/11 | Hospitalization due to grade 3 infection | No |
| 15 | 11/05/11 | Hospitalization due to grade 3 dizziness and grade 2 impaired mobility | No |
Dec-11 |
| 16 | 12/08/11 | Hospitalization due to grade 3 stroke and grade 1 rash | No |
Jan-12 |
| 17 | 10/05/11 | Hospitalized due to grade 4 febrile neutropenia | No |
| 18 | 12/20/11 | Death due to grade 3 delirium, UTI and pneumonia | No |
Event Number | Date of event | Main event (brief description) | Related to study drug? |
| May - 11 |
1 | 3/22/11 | Grade 3 rash | Unlikely |
| Sept - 11 |
2 | 7/6/11 | Hospitalization due to grade 2 chest pain | Unrelated |
3 | 9/10/11 | Hospitalization due to grade 2 respiratory disorder | Unrelated |
*Denotes addendum for clarification or resolution.
The third annual Biothreat Agents Workshop will be held on Monday March 15 from 8 a.m. to 5 p.m., with an evening...
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