Table 3.
OR of reporting AEs by medication class of pregnancy in JADER, categorized based on system organ class (SOC)
| Class 1 n=338 |
Class 2 n=55 |
Class 3 n=285 |
Class 4 n=582 |
Class 5 n=63 |
Class 6 n=226 |
Class 7 n=25 |
Class 8 n=40 |
Class 9 n=6 |
Class 10 n=4 |
Class 11 n=30 |
Reports in pregnancy without psychiatric medications, n=5,876 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SOC | # reports OR (95%CI) |
# reports OR (95%CI) |
# reports OR (95%CI) |
# reports OR (95%CI) |
# reports OR (95%CI) |
# reports OR (95%CI) |
# reports OR (95%CI) |
# reports OR (95%CI) |
# reports OR (95%CI) |
# reports OR (95%CI) |
# reports OR (95%CI) |
n (reference) |
| Preg | 93 | 20 | 98 | 126 | 16 | 73 | 5 | 30 | 1 | 2 | 20 | 2,156 |
| 0.7 (0.5,0.8) | 1.0 (0.6,1.7) | 0.9 (0.7,1.2) | 0.5 (0.4,0.6) | 0.6 (0.3,1.0) | 0.8 (0.6,1.1) | - | 5.2 (2.5,10.6) | - | - | 3.4 (1.6,7.4) | 1.0 | |
| Cong | 135 | 3 | 42 | 124 | 14 | 93 | 7 | 5 | 0 | 1 | 3 | 1,037 |
| 3.1 (2.5,3.9) | - | 0.8 (0.6,1.1) | 1.3 (1.0,1.6) | 1.3 (0.7,2.4) | 3.3 (2.5,4.3) | 1.8 (0.8,4.4) | - | - | - | - | 1.0 | |
| Resp | 39 | 11 | 93 | 144 | 19 | 17 | 4 | 4 | 2 | 1 | 6 | 712 |
| 0.9 (0.7,1.3) | 1.8 (0.9,3.5) | 3.5 (2.7,4.6) | 2.4 (1.9,2.9) | 3.1 (1.8,5.4) | 0.6 (0.4,1.0) | - | - | - | - | 1.8 (0.7,4.5) | 1.0 | |
| Genrl | 37 | 7 | 65 | 169 | 15 | 21 | 5 | 1 | 2 | 1 | 1 | 252 |
| 2.7 (1.9,3.9) | 3.3 (1.5,7.3) | 6.6 (4.9,8.9) | 9.1 (7.3,11.4) | 7.0 (3.9,12.6) | 2.3 (1.4,3.6) | - | - | - | - | - | 1.0 | |
| Nerv | 30 | 4 | 37 | 108 | 12 | 23 | 3 | 1 | 4 | 0 | 2 | 420 |
| 1.3 (0.9,1.9) | - | 1.9 (1.4,2.8) | 3.0 (2.3,3.7) | 3.1 (1.6,5.8) | 1.5 (0.9,2.3) | - | - | - | - | - | 1.0 | |
| Psych | 9 | 3 | 13 | 39 | 7 | 16 | 0 | 3 | 1 | 0 | 2 | 28 |
| 5.7 (2.7,12.2) | - | 10.0 (5.1,19.5) | 15.0 (9.2,24.6) | 26.1 (10.9,62.3) | 15.9 (8.5,29.9) | - | - | - | - | - | 1.0 | |
| Inv | 12 | 6 | 23 | 32 | 2 | 4 | 2 | 2 | 0 | 0 | 0 | 389 |
| 0.5 (0.3,0.9) | 1.7 (0.7,4.1) | 1.2 (0.8,1.9) | 0.8 (0.6,1.2) | - | - | - | - | - | - | - | 1.0 | |
| Metab | 4 | 3 | 10 | 37 | 1 | 8 | 4 | 3 | 1 | 1 | 2 | 316 |
| - | - | 0.6 (0.3,1.2) | 1.2 (0.8,1.7) | - | 0.6 (0.3,1.3) | - | - | - | - | - | 1.0 | |
| Inj&P | 8 | 4 | 13 | 31 | 0 | 7 | 0 | 0 | 2 | 0 | 0 | 295 |
| 0.5 (0.2,0.9) | - | 0.9 (0.5,1.6) | 1.1 (0.7,1.6) | - | 0.6 (0.3,1.3) | - | - | - | - | - | 1.0 | |
| Card | 11 | 2 | 2 | 29 | 2 | 6 | 2 | 1 | 0 | 0 | 1 | 429 |
| 0.4 (0.2,0.8) | - | - | 0.7 (0.5,1.0) | - | 0.3 (0.2,0.8) | - | - | - | - | - | 1.0 | |
| Musc | 9 | 2 | 18 | 17 | 2 | 5 | 2 | 0 | 0 | 0 | 0 | 153 |
| 1.0 (0.5,2.0) | - | 2.5 (1.5,4.2) | 1.1 (0.7,1.9) | - | - | - | - | - | - | - | 1.0 | |
| Gastr | 4 | 2 | 6 | 22 | 4 | 9 | 1 | 1 | 0 | 0 | 0 | 284 |
| - | - | 0.4 (0.2,1.0) | 0.8 (0.5,1.2) | - | 0.8 (0.4,1.6) | - | - | - | - | - | 1.0 | |
| Surg | 15 | 2 | 6 | 5 | 1 | 14 | 1 | 1 | 0 | 0 | 3 | 149 |
| 1.8 (1.0,3.1) | - | 0.8 (0.4,1.9) | - | - | 2.5 (1.4,4.5) | - | - | - | - | - | 1.0 | |
| Blood | 0 | 7 | 3 | 26 | 0 | 5 | 1 | 0 | 0 | 0 | 0 | 339 |
| - | 2.4 (1.1,5.3) | - | 0.8 (0.5,1.1) | - | - | - | - | - | - | - | 1.0 | |
| Skin | 2 | 7 | 1 | 18 | 1 | 4 | 2 | 0 | 0 | 0 | 0 | 212 |
| - | 3.9 (1.7,8.7) | - | 0.9 (0.5,1.4) | - | - | - | - | - | - | - | 1.0 | |
| Hepat | 3 | 6 | 3 | 17 | 0 | 3 | 0 | 1 | 0 | 0 | 0 | 184 |
| - | 3.8 (1.6,9.0) | - | 0.9 (0.6,1.5) | - | - | - | - | - | - | - | 1.0 | |
| Infec | 0 | 2 | 3 | 12 | 1 | 5 | 3 | 0 | 0 | 0 | 1 | 194 |
| - | - | - | 0.6 (0.3,1.1) | - | - | - | - | - | - | - | 1.0 | |
| Immun | 1 | 3 | 0 | 14 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 172 |
| - | - | - | 0.8 (0.5,1.4) | - | - | - | - | - | - | - | 1.0 | |
| Eye | 2 | 0 | 3 | 6 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 43 |
| - | - | - | 1.4 (0.6,3.3) | - | - | - | - | - | - | - | 1.0 | |
| Repro | 2 | 0 | 2 | 9 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 160 |
| - | - | - | 0.6 (0.3,1.1) | - | - | - | - | - | - | - | 1.0 | |
| Vasc | 2 | 1 | 3 | 11 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 177 |
| - | - | - | 0.6 (0.3,1.1) | - | - | - | - | - | - | - | 1.0 | |
| Neopl | 1 | 1 | 0 | 3 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 46 |
| - | - | - | - | - | - | - | - | - | - | - | 1.0 | |
| Endo | 1 | 0 | 3 | 3 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 56 |
| - | - | - | - | - | - | - | - | - | - | - | 1.0 | |
| Ear | 3 | 0 | 0 | 2 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 16 |
| - | - | - | - | - | - | - | - | - | - | - | 1.0 | |
| Renal | 1 | 1 | 1 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 167 |
| - | - | - | - | - | - | - | - | - | - | - | 1.0 | |
| SocCi | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| - | - | - | - | - | - | - | - | - | - | - | 1.0 | |
| Prod | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| - | - | - | - | - | - | - | - | - | - | - | 1.0 |
Significant results with p<0.05 in boldface
OR was estimated in cells with > 5 events
AE Adverse event, OR Odds ratio, SOC System organ class, Blood Blood and lymphatic system disorders, Card Cardiac disorders, Cong Congenital, familial and genetic disorders, Ear Ear and labyrinth disorders, Endo Endocrine disorders, Eye Eye disorders, Gastr Gastrointestinal disorders, Genrl General disorders and administration site conditions, Hepat Hepatobiliary disorders, Immun Immune system disorders, Infec Infections and infestations, Inj&P Injury, poisoning and procedural complications, Inv Investigations, Metab Metabolism and nutrition disorders, Musc Musculoskeletal and connective tissue disorders, Neopl Neoplasms benign, malignant and unspecified (incl cysts and polyps), Nerv Nervous system disorders, Preg Pregnancy, puerperium and perinatal conditions, Prod Product issues, Psych Psychiatric disorders, Renal Renal and urinary disorders, Repro Reproductive system and breast disorders, Resp Respiratory, thoracic and mediastinal disorders, Skin Skin and subcutaneous tissue disorders, SocCi Social circumstances, Surg Surgical and medical procedures, Vasc Vascular disorders