Table 3 The top 30 signal strength of AEs of misoprostol ranked by ROR at the PTs level.
From: A disproportionality analysis of FDA adverse event reporting system events for misoprostol
System organ class | PTs | Case reports | ROR (95% CI) | PRR (95% CI) | χ2 | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|---|---|
Pregnancy, puerperium and perinatal conditions | Uterine tachysystole | 95 | 19203.92 (13024.98, 28314.1) | 18952.43 (12806.23, 28048.42) | 484695.03 | 12.32 (11.94) | 5103.31 (3687.8) |
Pregnancy, puerperium and perinatal conditions | Birth trauma | 16 | 2332.63 (1324.09, 4109.37) | 2327.49 (1318.36, 4109.04) | 27905.94 | 10.77 (10) | 1745.87 (1087.01) |
Pregnancy, puerperium and perinatal conditions | Traumatic delivery | 10 | 2330.7 (1138.95, 4769.45) | 2327.49 (1149.34, 4713.31) | 17441.21 | 10.77 (9.81) | 1745.87 (958.96) |
Pregnancy, puerperium and perinatal conditions | Precipitate labour | 15 | 2141.92 (1200.67, 3821.06) | 2137.49 (1210.74, 3773.61) | 24524.83 | 10.68 (9.89) | 1636.75 (1008.43) |
Pregnancy, puerperium and perinatal conditions | Post abortion haemorrhage | 29 | 1848.22 (1226.83, 2784.33) | 1840.83 (1219.71, 2778.24) | 42200.72 | 10.51 (9.94) | 1456.98 (1034.05) |
Pregnancy, puerperium and perinatal conditions | Failed trial of labour | 3 | 1746.34 (492.7, 6189.82) | 1745.62 (488.27, 6240.81) | 4184.69 | 10.45 (8.87) | 1396.7 (484.48) |
Pregnancy, puerperium and perinatal conditions | Uterine hyperstimulation | 16 | 1492.89 (869.77, 2562.4) | 1489.59 (860.45, 2578.74) | 19616.68 | 10.26 (9.51) | 1227.86 (781.33) |
Pregnancy, puerperium and perinatal conditions | Abnormal labour | 19 | 1278.99 (783.9, 2086.78) | 1275.64 (781.49, 2082.25) | 20461.21 | 10.08 (9.39) | 1078.75 (716.18) |
Pregnancy, puerperium and perinatal conditions | Labour pain | 10 | 932.28 (481.74, 1804.2) | 931 (478.12, 1812.86) | 8197.05 | 9.68 (8.78) | 821.59 (472.86) |
Pregnancy, puerperium and perinatal conditions | Anaphylactoid syndrome of pregnancy | 10 | 908.07 (469.7, 1755.56) | 906.82 (465.7, 1765.77) | 8008.16 | 9.65 (8.74) | 802.7 (462.38) |
Pregnancy, puerperium and perinatal conditions | Uterine atony | 20 | 660.54 (417.38, 1045.36) | 658.72 (419.68, 1033.91) | 12002.28 | 9.23 (8.59) | 602.02 (410.01) |
Pregnancy, puerperium and perinatal conditions | Uterine hypertonus | 19 | 556.55 (348.63, 888.48) | 555.09 (346.79, 888.5) | 9734.93 | 9.01 (8.35) | 514.29 (347.72) |
Injury, poisoning and procedural complications | Abortion induced incomplete | 13 | 4546.76 (2260.89, 9143.73) | 4538.61 (2241.22, 9190.96) | 35743.01 | 11.43 (10.53) | 2751.07 (1533.27) |
Injury, poisoning and procedural complications | Induced abortion haemorrhage | 8 | 3994.39 (1675.16, 9524.56) | 3989.99 (1684.37, 9451.64) | 20302.48 | 11.31 (10.2) | 2539.45 (1227.33) |
Injury, poisoning and procedural complications | Foetal exposure during delivery | 201 | 3749.26 (3156.32, 4453.57) | 3645.4 (3055.88, 4348.65) | 481139.09 | 11.23 (10.99) | 2395.36 (2074.02) |
Injury, poisoning and procedural complications | Induced abortion failed | 43 | 3595.67 (2488.01, 5196.46) | 3574.36 (2463.01, 5187.16) | 101601.63 | 11.21 (10.71) | 2364.48 (1737.48) |
Injury, poisoning and procedural complications | Uterine cervical laceration | 10 | 1109.86 (569.3, 2163.69) | 1108.33 (569.19, 2158.16) | 9547.8 | 9.9 (8.99) | 956.64 (547.21) |
Injury, poisoning and procedural complications | Perineal injury | 15 | 971.8 (565.99, 1668.55) | 969.79 (560.19, 1678.88) | 12746.52 | 9.73 (8.98) | 851.64 (541.78) |
Injury, poisoning and procedural complications | Uterine rupture | 95 | 525.09 (425.76, 647.61) | 518.23 (417.72, 642.92) | 45654.97 | 8.91 (8.61) | 482.49 (404.84) |
Investigations | Foetal heart rate decreased | 93 | 1334.27 (1067.79, 1667.26) | 1317.18 (1061.72, 1634.1) | 102901.82 | 10.11 (9.8) | 1108.3 (919.81) |
Investigations | Amniocentesis abnormal | 15 | 783.24 (459.11, 1336.19) | 781.62 (460.43, 1326.86) | 10517.08 | 9.46 (8.71) | 703.03 (449.65) |
Investigations | Foetal heart rate increased | 6 | 551.7 (240.22, 1267.09) | 551.25 (242.01, 1255.62) | 3054.37 | 9 (7.88) | 510.99 (254.84) |
Infections and infestations | Endometritis bacterial | 3 | 3492.68 (873.32, 13968.3) | 3491.24 (868.19, 14039.25) | 6978.48 | 11.18 (9.51) | 2327.83 (729.88) |
Infections and infestations | Post abortion infection | 7 | 2877.91 (1193.09, 6941.93) | 2875.14 (1190.18, 6945.55) | 14245.98 | 10.99 (9.84) | 2036.85 (974.96) |
Infections and infestations | Endometritis | 39 | 501.44 (362.06, 694.48) | 498.75 (357.42, 695.97) | 18081.92 | 8.86 (8.4) | 465.57 (354.51) |
Congenital, familial and genetic disorders | Congenital aqueductal stenosis | 3 | 1309.76 (381.55, 4496.03) | 1309.21 (380.84, 4500.66) | 3302.44 | 10.11 (8.56) | 1102.65 (392.87) |
Congenital, familial and genetic disorders | Congenital brain damage | 7 | 514.99 (238.94, 1110) | 514.5 (239.56, 1104.99) | 3341.31 | 8.9 (7.87) | 479.26 (252.06) |
Psychiatric disorders | Postpartum stress disorder | 9 | 6991.15 (2774.32, 17617.36) | 6982.48 (2779.31, 17542.11) | 31412.15 | 11.77 (10.66) | 3491.74 (1611.32) |
Endocrine disorders | Postpartum hypopituitarism | 3 | 1047.8 (311.29, 3526.93) | 1047.37 (310.7, 3530.65) | 2727.06 | 9.83 (8.3) | 910.89 (329.92) |
Cardiac disorders | Foetal heart rate disorder | 11 | 545.56 (295.24, 1008.1) | 544.73 (296.69, 1000.13) | 5538.05 | 8.98 (8.13) | 505.38 (302.34) |
