Appendix 8.7

Summary of Serious Adverse Events occurring in Protocols 203, 205, and 208 Considered to be Unlikely to be Related to Bupropion Sustained-Release

 

Patient #

Protocol #

Age

Gender

Dose

(mg/dl)

Duration (days)

Adverse Event

1057

203

24

F

0

1

Overdose

8031

205

46

F

0

2

Hypertension, Dizziness, Syncope

8066

205

35

M

100

63

Urinary Tract Infection and Prostatitis

11049

205

43

F

100

8

Cholelithiasis

2045

205

40

F

300

8

Myocardial Infarction, Coronary Artery Disease found on catheterization

004-019

208

37

M

300

1

Overdose

008-004

208

73

F

0

1

Seizure

009-022

208

60

M

300

19

Anterior Chest Pain, Coronary Artery Disease

020-072

208

40

F

200

5

Normomocytic, Normochromic Anemia

021-16

208

65

F

200

1

Myocardial Infarction

022-032

208

28

F

0

1

Seizure

025-025

208

61

F

300

1

Broken Ankle and Foot after Falling Down Stairs

025-045

208

45

M

300

19

Overdose

028-019

208

57

M

300

1

Hiatal Hernia

036-004

208

44

F

200

1

Overdose/Seizure

050-010

208

47

M

300

1

Abdominal Pain

051-021

208

31

F

300

1

Overdose

053-028

208

32

M

300

1

Overdose

 

Bupropion Sustained-Release Clinical Review                   64

 

 

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