Adverse Events/DSMB

Data Safety Monitoring Board:   DSMB Minutes December 2011
Next Meeting: June 2012

Adverse Events 

91105

97309

97509

98110

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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@wakehealth.edu. 

*Denotes addendum for clarification or resolution.

Archived Adverse Events  for closed studies.

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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

97309 Yoga

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

97509 Armodafinil

 

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

 

98110 ArginMax  

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.