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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