Adverse Events

Adverse Events 

98110 99211 99311

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.

 


  

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

10/11/12Hospitalization due to grade 3 mucositis

No

4

10/18/12Death, recurrent disease

No

5

11/02/12Grade 2 rheumatoid arthritis

No 

March - 13

6

02/22/13Death due to respiratory and cardiac arrest.

No

7

03/03/13Death due to post-op acute/subacute infarct causing brain edema.

No

May - 13

8

04/14/13Hospitalization due to grade 2 left popliteal nonocclusive DVT and pulmonary embolism

No

June - 13

9

06/03/13Hospitalizations due to grade 2 CP

No

July -13

10

06/22/13Death due to acute respiratory failure

No

11

07/10/13Hospitalization due to grade 2 pain

No

12

07/13/13Hospitalization due to grade 3 fatigue, pneumonia, UTI, pulminary embolism, anemia and dyspnea

No

August - 13

13

04/01/13Hospitalization due to planned surgery

No

September -13

14

8/10/13Death

No

15

8/14/13Death due to progressive disease

No

16

8/19/13Hospitalization due to grade 3 anemia

No

17

9/19/13Hospitalization due to grade 3 sinus tachycardia

No

October - 13

18

09/14/13Hospitalization due to grade 2 headache, strep  throat and pneumonia    

No

19

10/08/13Hospitalization due to grade 3 neutophil count

No

20

10/14/13Hospitalization due to grade 4 dyspnea, grade 3 hypoxemia and COPD exacerbation

No

November - 13

21

09/29/13Hospitalization due to grade 4 neutropenia

No

January -14

22

11/17/13Death due to disease progression.

No

     23         12/19/13  Hospitalization due to risk reducing prophylactic hysterectomy                                                                              No
     24          06/22/14   Death due to disease progression                                                                                                                         No
     25          09/03/14    Hospitalization due to grade 3 wound infection.                                                                                                   No
   October - 14
    26           09/09/14  Hospitalization due to grade 3 COPD and Hyperclycemia                                                                                     No
    27            06/14/14  Hospitalization due to grade 3 intractable diarrhea                                                                                               No
    28            9/24/14    Hospitalization due to grade 3  infection                                                                                                               No
    29            10/26/14  Death due to severe sepsis                                                                                                                                   No
November - 14   
   30            11/14/14  Hospitalization due to grade 3 hypoxia                                                                                                                 No

99311 - Memantine

Event
Number
Date of
Event
Main Event
(brief description)
Related to
Study Drug?
December 2012

1

12/13/12Hospitalization, grade 4 ventricular fibrillation and grade 3 ACS

No

March  2013

2

03/18/13Hospitalization due to grade 2 chest pain and dyspnea.

No

August 2013

3

7/6/13Hospitalization due to cellulitis and low blood pressure

No

November 2013

4

11/02/13Hospitalization due to grade 3 pelvic pain

No

 

*Denotes addendum for clarification or resolution.

 

 

Quick Reference

Research Base

Fax 336-716-6275
Phone 336-716-0891

2000 West First Street
Protocol Information Office
Suite 101
Winston-Salem, NC 27104
Find A Doctor Ways to Give
Last Updated: 12-03-2014
USNWR 2013-2014Magnet Hospital RecognitionConsumer Choice2014 Best DoctorsJoint Commission Report

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.