Table 3 Signal strength of the top 5 individual PTs under the top 10 SOCs of reported frequency.
SOC (top 10) | PTs (top 5 per SOC) | Cases (n) | ROR (95%CI) | PRR(χ2) | EBGM (EBGM05) | IC (IC025) |
|---|---|---|---|---|---|---|
General disorders and administration site conditions | Fatigue | 372 | 4.1 (3.7–4.56) | 3.95 (827.92) | 3.94 (3.61) | 1.98 (1.83) |
Pain | 104 | 1.21 (1–1.47) | 1.21 (3.76) | 1.21 (1.03) | 0.27 (− 0.01) | |
Feeling abnormal | 65 | 2.67 (2.09–3.41) | 2.66 (67.27) | 2.65 (2.16) | 1.41 (1.05) | |
Malaise | 50 | 1.12 (0.85–1.48) | 1.12 (0.66) | 1.12 (0.89) | 0.17 (− 0.24) | |
Swelling face | 49 | 7.9 (5.96–10.47) | 7.86 (292.65) | 7.84 (6.19) | 2.97 (2.56) | |
Investigations | Aspartate aminotransferase increased | 124 | 26.84 (22.46–32.08) | 26.41 (3007.35) | 26.19 (22.56) | 4.71 (4.45) |
Alanine aminotransferase increased | 116 | 20.69 (17.21–24.87) | 20.38 (2125.5) | 20.25 (17.36) | 4.34 (4.07) | |
Gamma-Glutamyltransferase increased | 73 | 41.61 (32.99–52.48) | 41.2 (2826.53) | 40.67 (33.49) | 5.35 (5.01) | |
Blood alkaline phosphatase increased | 69 | 38.97 (30.7–49.47) | 38.61 (2497.47) | 38.15 (31.25) | 5.25 (4.9) | |
Hepatic enzyme increased | 67 | 7.97 (6.26–10.14) | 7.91 (403.66) | 7.89 (6.45) | 2.98 (2.63) | |
Skin and subcutaneous tissue disorders | Hair colour changes | 300 | 224.64(199.36–253.11) | 215.46(59872.94) | 201.47(182.32) | 7.65 (7.48) |
Pruritus | 165 | 3.71 (3.18–4.33) | 3.65 (319.01) | 3.65 (3.2) | 1.87 (1.64) | |
Rash | 127 | 2.48 (2.08–2.96) | 2.45 (110.1) | 2.45 (2.12) | 1.29 (1.04) | |
Alopecia | 48 | 2.09 (1.58–2.78) | 2.09 (27.25) | 2.09 (1.65) | 1.06 (0.65) | |
Skin discolouration | 47 | 9.5 (7.13–12.66) | 9.44 (353.92) | 9.42 (7.4) | 3.24 (2.82) | |
Injury, poisoning and procedural complications | Product dose omission issue | 341 | 5.57 (5–6.21) | 5.36 (1217.1) | 5.35 (4.88) | 2.42 (2.26) |
Off label use | 110 | 0.78 (0.65–0.94) | 0.79 (6.54) | 0.79 (0.67) | − 0.35(− 0.62) | |
Product dose omission in error | 83 | 16.24 (13.07–20.17) | 16.07 (1167.4) | 15.99 (13.33) | 4 (3.68) | |
Product use issue | 52 | 2.19 (1.67–2.88) | 2.18 (33.32) | 2.18 (1.73) | 1.12 (0.73) | |
Incorrect dose administered | 35 | 1.16 (0.84–1.62) | 1.16 (0.81) | 1.16 (0.88) | 0.22 (− 0.26) | |
Gastrointestinal disorders | Nausea | 203 | 2.51 (2.18–2.88) | 2.46 (178.34) | 2.46 (2.19) | 1.3 (1.1) |
Diarrhoea | 105 | 1.35 (1.12–1.64) | 1.35 (9.61) | 1.35 (1.15) | 0.43 (0.15) | |
Vomiting | 60 | 1.26 (0.97–1.62) | 1.25 (3.09) | 1.25 (1.01) | 0.33 (− 0.05) | |
Abdominal discomfort | 57 | 2.69 (2.08–3.5) | 2.68 (60.21) | 2.68 (2.15) | 1.42 (1.04) | |
Constipation | 55 | 2.19 (1.68–2.86) | 2.19 (35.47) | 2.18 (1.75) | 1.13 (0.74) | |
Nervous system disorders | Headache | 86 | 1.29 (1.04–1.59) | 1.28 (5.44) | 1.28 (1.07) | 0.36 (0.05) |
Dizziness | 71 | 1.41 (1.12–1.78) | 1.41 (8.36) | 1.41 (1.16) | 0.49 (0.15) | |
Somnolence | 50 | 2.4 (1.82–3.17) | 2.39 (40.43) | 2.39 (1.89) | 1.26 (0.85) | |
Taste disorder | 39 | 8.62 (6.29–11.81) | 8.58 (260.46) | 8.56 (6.57) | 3.1 (2.64) | |
Memory impairment | 33 | 2.1 (1.49–2.96) | 2.1 (18.95) | 2.1 (1.57) | 1.07 (0.57) | |
Musculoskeletal and connective tissue disorders | Arthralgia | 88 | 1.68 (1.36–2.07) | 1.67 (23.78) | 1.67 (1.4) | 0.74 (0.43) |
Pain in extremity | 44 | 1.41 (1.05–1.9) | 1.41 (5.23) | 1.41 (1.1) | 0.49 (0.06) | |
Joint swelling | 37 | 2.23 (1.61–3.08) | 2.22 (24.94) | 2.22 (1.7) | 1.15 (0.68) | |
Back pain | 25 | 1 (0.68–1.48) | 1 (0) | 1 (0.72) | 0 (− 0.56) | |
Arthropathy | 13 | 1.68 (0.97–2.89) | 1.68 (3.57) | 1.68 (1.06) | 0.75 (− 0.03) | |
Eye disorders | Periorbital swelling | 64 | 53.81 (41.99–68.97) | 53.35 (3232.29) | 52.46 (42.62) | 5.71 (5.35) |
Eye swelling | 46 | 12.39 (9.27–16.57) | 12.32 (476.91) | 12.28 (9.63) | 3.62 (3.19) | |
Vision blurred | 24 | 1.77 (1.18–2.64) | 1.76 (7.96) | 1.76 (1.26) | 0.82 (0.24) | |
Visual impairment | 16 | 1.04 (0.63–1.69) | 1.04 (0.02) | 1.04 (0.69) | 0.05 (− 0.65) | |
Swelling of eyelid | 11 | 8.88 (4.91–16.05) | 8.87 (76.58) | 8.85 (5.39) | 3.14 (2.31) | |
Infections and infestations | Covid-19 | 49 | 0.96 (0.72–1.27) | 0.96 (0.09) | 0.96 (0.76) | − 0.06 (− 0.47) |
Nasopharyngitis | 29 | 1.31 (0.91–1.88) | 1.31 (2.09) | 1.31 (0.96) | 0.39 (− 0.14) | |
Influenza | 19 | 1.48 (0.94–2.32) | 1.48 (2.95) | 1.48 (1.01) | 0.56 (− 0.08) | |
Urinary tract infection | 13 | 0.64 (0.37–1.09) | 0.64 (2.72) | 0.64 (0.4) | − 0.65(− 1.42) | |
Sinusitis | 11 | 0.9 (0.5–1.62) | 0.9 (0.12) | 0.9 (0.55) | − 0.15(− 0.99) | |
Surgical and medical procedures | Therapy cessation | 65 | 9 (7.05–11.49) | 8.93 (456.65) | 8.9 (7.26) | 3.15 (2.8) |
Therapy interrupted | 38 | 2.45 (1.78–3.37) | 2.44 (32.37) | 2.44 (1.87) | 1.29 (0.82) | |
Surgery | 32 | 4.6 (3.25–6.5) | 4.58 (89.49) | 4.57 (3.42) | 2.19 (1.69) | |
Therapy change | 17 | 12.91 (8.01–20.8) | 12.88 (185.6) | 12.83 (8.61) | 3.68 (3) | |
Knee arthroplasty | 8 | 2.9 (1.45–5.8) | 2.9 (9.93) | 2.9 (1.62) | 1.53 (0.57) |
