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Adverse Events/DSMB

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

Adverse Events 

97211

97509

97609

98110

99211

99311

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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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  97211 Cognitive Dysfunction

Event Number	Date of event	Main event (brief description)	Related to study drug?
February - 13
1	02/01/13	Hospitalization due to grade 4 E Coli bacteremia	No
March - 13
2	02/20/13	Hospitalization due to grade 3 chest pain	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
October-12
19	09/25/12	Hospitalization due to grade 3 chest pain and grade 4 acute coronary syndrome	No
November -12
20	10/30/12	Hospitalization due to grade 3 pulmonary embolus	No
December -12
21	12/03/12	Hospitalization due to grade 3 fall	No
22	12/09/12	Hospitalization due to grade 2 mucosal infection	No

97609 Biomarkers 

These AEs are posted for infomational purposes only.

Event Number	Date of event	Main event (brief description)	Related to study?
February  - 13
1	01/21/13	Death due to advanced disease	No
March - 13
2	03/01/13	Hospitalization due to grade 4 neoplasm, benign, malignant and upsecificed meningioma	No
3	03/11/13	Bleeding  at treatment site	No
April - 13
4	06/22/12	Hospitalization due to grade 3 cognitive function	No
5	97609 AE 5 was submitted and posted in error.  The Grade 4 toxicity was a Grade 4 from the ONS Case Report Form not the CTC.
6	01/27/13	Death.  Unrelated to study.	No
7	04/09/13	Hospitalization due to grade 3 mitral valve	No
May - 13
8	02/16/13	Hospitalization due to grade 3 dizziness and grade 2 weakness	No
9	02/20/13	Death due to grade 4 sepsis and colitis.  Death unrelated to study.	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

 
99211 Quitline

Event Number	Date of event	Main event (brief description)	Related to study drug?
July - 12
1	06/20/12	Hospitalization due to grade 1 fever, grade 2 dypsnea and cough and grade 3 hypertension	No
September - 12
2	09/13/12	Hospitalization due to grade 3 dehydration, anorexia,  dsyphagia, pain and fatigue; and grade 2 pharyngitis	No
November -12
3	10/11/12	Hospitalization due to grade 3 mucositis	No
4	10/18/12	Death, recurrent disease	No
5	11/02/12	Grade 2 rheumatoid arthritis	No
March - 13
6	02/22/13	Death due to respiratory and cardiac arrest.	No
7	03/03/13	Death due to post-op acute/subacute infarct causing brain edema.	No
May - 13
8	04/14/13	Hospitalization due to grade 2 left popliteal nonocclusive DVT and pulmonary embolism	No

 

99311 - Memantine

Event Number	Date of Event	Main Event (brief description)	Related to Study Drug?
December 2012
1	12/13/12	Hospitalization, grade 4 ventricular fibrillation and grade 3 ACS	No
March  2013
2	03/18/13	Hospitalization due to grade 2 chest pain and dyspnea.	No

 

*Denotes addendum for clarification or resolution.