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A peer-reviewed article of this preprint also exists.
supplementary.pdf (456.72KB )
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Submitted:
12 June 2024
Posted:
12 June 2024
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Characteristics | Total | SCBs | Non-SCBs | p-value | |||
---|---|---|---|---|---|---|---|
N | % | N | % | N | % | ||
Reports | 46,963 | 100.0 | 14,847 | 31.6 | 32,116 | 68.4 | - |
Sex | <.0001 | ||||||
Male | 16,349 | 34.8 | 5,891 | 39.7 | 10,458 | 32.6 | |
Female | 29,454 | 62.7 | 8,403 | 56.6 | 21,051 | 65.5 | |
Unknown | 1,160 | 2.5 | 553 | 3.7 | 607 | 1.9 | |
Age group | <.0001 | ||||||
00-09 | 1,494 | 3.2 | 1,093 | 7.4 | 401 | 1.3 | |
10-19 | 1,580 | 3.4 | 1,177 | 7.9 | 403 | 1.3 | |
20-29 | 2,717 | 5.8 | 1,775 | 12.0 | 942 | 2.9 | |
30-39 | 3,577 | 7.6 | 1,815 | 12.2 | 1,762 | 5.5 | |
40-49 | 5,319 | 11.3 | 1,907 | 12.8 | 3,412 | 10.6 | |
50-59 | 9,300 | 19.8 | 2,409 | 16.2 | 6,891 | 21.5 | |
>60 | 21,509 | 45.8 | 3,837 | 25.8 | 17,672 | 55.0 | |
Unknown | 1,467 | 3.1 | 834 | 5.6 | 633 | 2.0 | |
Original reporter | <.0001 | ||||||
Clinician | 9,805 | 20.9 | 4,495 | 36.0 | 5,310 | 15.4 | |
Pharmacist | 18,396 | 39.2 | 2,167 | 17.4 | 16,229 | 47.1 | |
Nurse | 14,974 | 31.9 | 4,484 | 35.9 | 10,493 | 30.4 | |
Other medical specialists | 251 | 0.5 | 167 | 1.3 | 167 | 0.5 | |
Consumer | 2,629 | 5.6 | 999 | 8.0 | 1,630 | 4.7 | |
Unknown | 908 | 1.9 | 260 | 2.1 | 648 | 1.9 | |
Assessment | <.0001 | ||||||
Certain | 817 | 1.7 | 399 | 2.7 | 418 | 1.3 | |
Probable/likely | 11,868 | 25.3 | 5,247 | 35.3 | 6,621 | 20.6 | |
Possible | 34,278 | 73.0 | 9,201 | 62.0 | 25,077 | 78.1 | |
Seriousness | <.0001 | ||||||
Yes | 2,888 | 6.1 | 1,903 | 12.8 | 985 | 3.1 | |
No | 44,075 | 93.9 | 12,944 | 87.2 | 31,131 | 96.9 | |
Seriousness category | <.0001 | ||||||
Death | 65 | 0.1 | 26 | 0.2 | 39 | 0.1 | |
Life-threatening | 130 | 0.3 | 76 | 0.5 | 54 | 0.2 | |
Hospitalization | 1,633 | 3.5 | 1,144 | 7.7 | 489 | 1.5 | |
Disability | 31 | 0.1 | 22 | 0.2 | 9 | 0.0 | |
Congenial anomaly | 2 | 0.0 | 2 | 0.0 | - | - | |
Other significant medical events | 1,240 | 2.6 | 818 | 5.5 | 422 | 1.3 |
SOC | Total | SCBs | Non-SCBs | ||||
---|---|---|---|---|---|---|---|
N | % | N | % | N | % | ||
Total | 46,963 | 100 | 14,847 | 100.0 | 32,116 | 100.0 | |
Central & peripheral nervous system disorders | 12,484 | 26.6 | 2,477 | 16.7 | 10,007 | 31.2 | |
Skin and appendages disorders | 8,438 | 18.0 | 5,631 | 37.9 | 2,807 | 8.7 | |
Gastro-intestinal system disorders | 8,413 | 17.9 | 1,351 | 9.1 | 7,062 | 22.0 | |
Psychiatric disorders | 7,290 | 15.5 | 1,436 | 9.7 | 5,854 | 18.2 | |
Body as a whole - general disorders | 3,810 | 8.1 | 1,078 | 7.3 | 2,732 | 8.5 | |
Liver and biliary system disorders | 1,197 | 2.5 | 662 | 4.5 | 535 | 1.7 | |
Metabolic and nutritional disorders | 1,092 | 2.3 | 495 | 3.3 | 597 | 1.9 | |
White cell and RES* disorders | 577 | 1.2 | 380 | 2.6 | 197 | 0.6 | |
Platelet, bleeding & clotting disorders | 416 | 0.9 | 308 | 2.1 | 108 | 0.3 | |
Vision disorders | 519 | 1.1 | 193 | 1.3 | 326 | 1.0 | |
Urinary system disorders | 936 | 2.0 | 146 | 0.98 | 790 | 2.46 | |
Respiratory system disorders | 381 | 0.8 | 130 | 0.9 | 251 | 0.8 | |
Heart rate and rhythm disorders | 257 | 0.5 | 101 | 0.7 | 156 | 0.5 | |
Secondary terms - events | 159 | 0.3 | 89 | 0.6 | 70 | 0.2 | |
Musculo-skeletal system disorders | 338 | 0.7 | 81 | 0.5 | 257 | 0.8 | |
Cardiovascular disorders, general | 212 | 0.5 | 67 | 0.5 | 145 | 0.5 | |
Red blood cell disorders | 87 | 0.2 | 51 | 0.3 | 36 | 0.1 | |
Reproductive disorders, female | 72 | 0.2 | 44 | 0.30 | 28 | 0.087 | |
Hearing and vestibular disorders | 69 | 0.1 | 33 | 0.2 | 36 | 0.1 | |
Vascular (extracardiac) disorders | 60 | 0.1 | 30 | 0.2 | 30 | 0.1 | |
Special senses other, disorders | 65 | 0.1 | 15 | 0.1 | 50 | 0.2 | |
Neonatal and infancy disorders | 11 | 0.0 | 11 | 0.1 | - | 0.0 | |
Resistance mechanism disorders | 14 | 0.0 | 8 | 0.1 | 6 | 0.019 | |
Reproductive disorders, male | 22 | 0.0 | 7 | 0.0 | 15 | 0.047 | |
Endocrine disorders | 15 | 0.0 | 6 | 0.0 | 9 | 0.0 | |
Neoplasms | 10 | 0.0 | 6 | 0.0 | 4 | 0.0 | |
Application site disorders | 8 | 0.0 | 6 | 0.0 | 2 | 0.0 | |
Collagen disorders | 7 | 0.0 | 3 | 0.0 | 4 | 0.0 | |
Foetal disorders | 2 | 0.0 | 2 | 0.01 | - | 0.000 | |
Poison specific terms | 2 | 0.0 | - | 0.00 | 2 | 0.01 |
Group | SOC ROR (95% CI) | ||||
---|---|---|---|---|---|
Drug | Skin and appendages disorders | CNS & PNS system disorders | Psychiatric disorders | Gastro-intestinal system disorders | Body as a whole - general disorders |
SCBs | |||||
Carbamazepine | 4.22 (3.91-4.54) | 0.51 (0.46-0.56) | 0.36 (0.31-0.41) | 0.41 (0.36-0.47) | 1.4 (1.24-1.57) |
Lacosamide | 0.89 (0.7-1.13) | 1.41 (1.16-1.7) | 1.09 (0.86-1.39) | 0.47 (0.35-0.64) | 0.34 (0.2-0.58) |
Lamotrigine | 10.96 (10.04-11.97) | 0.16 (0.13-0.19) | 0.29 (0.24-0.34) | 0.21 (0.17-0.25) | 1.11 (0.96-1.28) |
Oxcarbazepine | 6.44 (5.79-7.16) | 0.36 (0.31-0.43) | 0.32 (0.26-0.4) | 0.29 (0.24-0.36) | 0.58 (0.45-0.73) |
Phenytoin | 3.41 (2.97-3.91) | 0.55 (0.46-0.66) | 0.27 (0.2-0.37) | 0.31 (0.24-0.41) | 0.83 (0.64-1.09) |
Valproate | 1.74 (1.61-1.87) | 0.48 (0.44-0.52) | 0.59 (0.53-0.65) | 0.64 (0.58-0.7) | 0.67 (0.58-0.77) |
Topiramate | 0.52 (0.45-0.59) | 1.21 (1.11-1.33) | 1.46 (1.32-1.62) | 0.56 (0.49-0.64) | 0.71 (0.6-0.84) |
Non-SCBs | |||||
Clonazepam | 0.38 (0.33-0.44) | 0.77 (0.7-0.85) | 3.05 (2.8-3.33) | 0.95 (0.86-1.06) | 0.84 (0.72-0.99) |
Gabapentin | 0.25 (0.24-0.27) | 1.24 (1.18-1.29) | 1.38 (1.31-1.46) | 1.92 (1.83-2.02) | 1.23 (1.15-1.32) |
Levitiracetam | 1.93 (1.78-2.09) | 0.37 (0.33-0.41) | 0.96 (0.86-1.06) | 0.64 (0.58-0.71) | 0.67 (0.58-0.78) |
Phenobarbital | 4.62 (3.58-5.96) | 0.15 (0.08-0.26) | 0.47 (0.29-0.75) | 0.22 (0.12-0.4) | 1.21 (0.79-1.87) |
Pregabalin | 0.19 (0.17-0.2) | 2.37 (2.27-2.48) | 1.01 (0.96-1.07) | 1.47 (1.4-1.55) | 1.12 (1.04-1.2) |
ROR | >1 | <1 | Not significant |
Top | SCBs | Non-SCBs | |||||
---|---|---|---|---|---|---|---|
ADR | Reports (n) | % | ADR | Reports (n) | % | ||
1 | Rash | 2,644 | 17.8 | Dizziness | 7,597 | 23.7 | |
2 | Pruritus | 1,219 | 8.2 | Somnolence | 4,184 | 13.0 | |
3 | Dizziness | 999 | 6.7 | Nausea | 2,020 | 6.3 | |
4 | Urticaria | 916 | 6.2 | Constipation | 1,193 | 3.7 | |
5 | Somnolence | 577 | 3.9 | Vomiting | 1,172 | 3.6 | |
6 | Nausea | 359 | 2.4 | Mouth Dry | 1,076 | 3.4 | |
7 | Hepatic Enzymes Increased | 352 | 2.4 | Rash | 1,003 | 3.1 | |
8 | Fever | 333 | 2.2 | Dyspepsia | 886 | 2.8 | |
9 | Thrombocytopenia | 285 | 1.9 | Pruritus | 849 | 2.6 | |
10 | Paraesthesia | 272 | 1.8 | Headache | 695 | 2.2 | |
11 | Vomiting | 263 | 1.8 | Urticaria | 478 | 1.5 | |
12 | Headache | 228 | 1.5 | Asthenia | 450 | 1.4 | |
13 | Leucopenia | 210 | 1.4 | Oedema Generalised | 442 | 1.4 | |
14 | Drug Hypersensitivity Syndrome | 207 | 1.4 | Hepatic Enzymes Increased | 429 | 1.3 | |
15 | Constipation | 198 | 1.3 | Face Oedema | 426 | 1.3 | |
16 | Tremor | 197 | 1.3 | Oedema | 384 | 1.2 | |
17 | Stevens Johnson Syndrome | 170 | 1.1 | Tremor | 327 | 1.0 | |
18 | Dyspepsia | 163 | 1.1 | Insomnia | 307 | 1.0 | |
19 | Weight Increase | 145 | 1.0 | Weight Increase | 289 | 0.9 | |
20 | Anorexia | 139 | 0.9 | Oedema Peripheral | 280 | 0.9 | |
Total of Top20 | 9,876 | 66.52 | Total of Top20 | 24,487 | 76.25 | ||
Others | 4,971 | 33.5 | Others | 7,629 | 23.8 |
Median time to onset 1 Days (Q1, Q3) |
Median time to onset 2 Days (Q1, Q3) |
|||
---|---|---|---|---|
ADR | SCBs | Non-SCBs | SCBs | Non-SCBs |
Dizziness | 0 (0, 2) | 0 (0, 1) | 1 (0, 10) | 0 (0, 1) |
Somnolence | 0 (0, 1) | 0 (0, 0) | 0 (0, 10) | 0 (0, 1) |
Rash | 3 (0, 9) | 1 (0, 5) | 9 (1, 84) | 3 (0, 72) |
Nausea | 0 (0, 1) | 0 (0, 1) | 0 (0, 6) | 0 (0, 1) |
Pruritus | 2 (0, 7) | 0 (0, 2) | 7 (0, 83) | 1 (0, 10) |
Vomiting | 0 (0, 2) | 0 (0, 1) | 1 (0, 6) | 0 (0, 1) |
Urticaria | 2 (0, 8) | 0 (0, 2) | 8 (0, 82) | 1 (0, 8) |
Constipation | 0 (0, 5) | 0 (0, 2) | 3 (0, 20) | 0 (0, 5) |
Mouth Dry | 0 (0, 0) | 0 (0, 0) | 0 (0, 5) | 0 (0, 0) |
Dyspepsia | 0 (0, 1) | 0 (0, 0) | 0 (0, 14) | 0 (0, 0) |
Sexual/Reproductive SOC ADRs |
SCBs Number of reports (%) |
Non-SCBs Number of reports (%) |
P-value |
---|---|---|---|
Total | 64 (59.8%) | 43 (40.2%) | <0.0001 |
Reproductive disorders, male | 7 (31.8%) | 15 (68.2%) | 0.4642 |
Balanoposthitis | 0 | 1 | |
Ejaculation Disorder | 0 | 2 | |
Ejaculation Failure | 0 | 3 | |
Ejaculation Premature | 2 | 1 | |
Priapism | 0 | 1 | |
Semen Abnormal | 1 | 0 | |
Sexual Function Abnormal | 4 | 7 | |
Reproductive disorders, female | 44 (61.1%) | 28 (38.9%) | 0.0081 |
Amenorrhoea | 6 | 1 | |
Breast Discomfort | 0 | 1 | |
Breast Engorgement | 2 | 1 | |
Breast Enlargement | 1 | 4 | |
Breast Pain | 1 | 3 | |
Breast Pain Female | 1 | 1 | |
Dysmenorrhoea | 3 | 0 | |
Gynecological-Related Pain | 1 | 0 | |
Lactation Nonpuerperal | 1 | 3 | |
Leukorrhoea | 1 | 1 | |
Menorrhagia | 1 | 0 | |
Menstrual Disorder | 23 | 8 | |
Post-Menopausal Bleeding | 0 | 1 | |
Uterine Atony | 0 | 1 | |
Vaginal Discomfort | 0 | 1 | |
Vaginal Haemorrhage | 0 | 2 | |
Vaginitis | 3 | 0 | |
Foetal disorders | 2 (100.0%) | 0 (0.0%) | - |
Drug Exposure In Pregnancy | 2 | 0 | |
Neonatal and infancy disorders | 11 (100.0%) | 0 (0.0%) | - |
Psychomotor Development Impaired | 11 | 0 |
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