|
|
9f |
65C-3883
44
Table 7. Morphological Defects
Observed in CD Rat Fetuses: Listing by Defect Typea
|
|
323U66 HCl (mg/kg/day, po) |
||||
|
|
0 |
75 |
150 |
300 |
300b |
|
ANY
MALFORMATIONS |
|||||
|
Total
No. of Fetuses for any Malformationsc |
443 |
384 |
419 |
376 |
336 |
|
No.
of Fetuses with any Malformationsd |
48 |
36 |
35 |
28 |
45 |
|
%
Fetuses with Any Malformations |
10.8% |
9.4% |
8.4% |
7.4% |
13.4% |
|
Total
No. of Litters Examined for Any Malformationse |
29 |
27 |
27 |
25 |
24 |
|
No.
of Litters with Any Malformationsf |
12 |
11 |
11 |
10 |
14 |
|
%
Litters with Any Malformations |
41.4% |
40.7% |
40.7% |
40.0% |
58.3% |
|
|
|
|
|
|
|
|
EXTERNAL
MALFORMATIONS |
|
|
|
|
|
|
Total
No. of Fetuses Examined for External Malformationsc |
443 |
384 |
419 |
376 |
336 |
|
No.
of Fetuses with External Malformationsd |
0 |
0 |
0 |
0 |
0 |
|
%
Fetuses with External Malformations |
0.0% |
0.0% |
0.0% |
0.0% |
0.0% |
|
Total
No. of Litters Examined for External Malformationse |
29 |
27 |
27 |
25 |
24 |
|
No.
of Litters with External Malformationsf |
0 |
0 |
0 |
0 |
0 |
|
%
Litters with External Malformations |
0.0% |
0.0% |
0.0% |
0.0% |
0.0% |
|
|
|
|
|
|
|
|
VISCERAL
MALFORMATIONS |
|
|
|
|
|
|
Total
No. of Fetuses Examined for Visceral Malformationsc |
222 |
192 |
209 |
190 |
168 |
|
No.
of Fetuses with Visceral Malformationsd |
48 |
36 |
35 |
28 |
44 |
|
%
Fetuses with Visceral Malformations |
21.6% |
18.8% |
16.7% |
14.7% |
26.2% |
|
Total
No. of Litters Examined for Visceral Malformationse |
29 |
27 |
27 |
25 |
24 |
|
No.
of Letters with Visceral Malformationsf |
12 |
11 |
11 |
10 |
13 |
|
%
Litters with Visceral Malformations |
41.4% |
40.7% |
40.7% |
40.0% |
54.2% |
|
|
|
|
|
|
|
|
Hydrocephaly:
Mild |
|
4(1) |
|
2(2) |
|
|
Hydronephrosia:
Right |
|
|
|
1(1) |
|
|
Hydrouereter: Bilateral |
26(9) |
20(8) |
19(8) |
17(6) |
22(8) |
|
Left |
22(11) |
16(9) |
16(10) |
8(5) |
22(12) |
|
Right |
|
|
|
1(1) |
|
(continued)
Back a Page
Next Page
Back to Wellbutrin SRŪ NDA Index Page
Back to Main
Index