Computational and Mathematical Methods in Medicine / 2020 / Article / Tab 3

Research Article

Assessment of the Potential Adverse Events Related to Ribavirin-Interferon Combination for Novel Coronavirus Therapy

Table 3

All the detected adverse events displayed according to SOC and PT.

PTReportsPRR (95% CI)ROR (95% CI)IC (IC-2SD)Listed in the drug labels

Blood and lymphatic system disorders
Anemia25612.45 (11.09, 13.98)12.48 (11.68, 13.34)3.42 (3.22)Yes
Neutropenia877.40 (6.03, 9.10)7.41 (6.65, 8.27)2.74 (2.42)Yes
Splenomegaly96.48 (3.38, 12.45)6.49 (4.65, 9.07)2.06 (1.15)No
Aplastic anemia813.65 (6.83, 27.29)13.68 (9.60, 19.51)2.50 (1.54)Yes
Endocrine disorders
Hypothyroidism319.36 (6.60, 13.28)9.37 (7.82, 11.24)2.88 (2.36)Yes
Thyroid disorder229.03 (5.95, 13.69)9.04 (7.30, 11.20)2.73 (2.12)Yes
Hyperthyroidism1811.61 (7.33, 18.41)11.64 (9.18, 14.75)2.89 (2.36)Yes
Eye disorders
Visual acuity reduced234.27 (2.84, 6.42)4.28 (3.47, 5.27)1.90 (1.30)Yes
Retinal exudates1395.68 (55.36, 165.36)97.48 (73.62, 129.09)3.62 (2.85)Yes
Vogt-Koyanagi-Harada syndrome9355.71 (180.91, 699.39)382.31 (270.42, 540.51)3.29 (2.37)Yes
Gastrointestinal disorders
Vomiting1072.04 (1.70, 2.45)2.04 (1.85, 2.25)0.98 (0.69)Yes
Diarrhea851.30 (1.05, 1.60)1.30 (1.16, 1.45)0.36 (0.03)Yes
Abdominal pain391.47 (1.08, 2.01)1.47 (1.25, 1.73)0.53 (0.07)Yes
Ascites318.55 (6.03, 12.14)8.57 (7.15, 10.27)2.78 (2.26)No
Abdominal distension262.23 (1.52, 3.27)2.23 (1.83, 2.72)1.08 (0.52)Yes
Proctalgia2229.82 (19.65, 45.25)29.99 (24.19, 37.17)3.72 (3.11)No
Hemorrhoids228.95 (5.90, 13.56)8.96 (7.23, 11.10)2.72 (2.12)No
Pancreatitis acute217.34 (4.79, 11.23)7.35 (5.90, 9.15)2.50 (1.88)Yes
Rectal hemorrhage193.47 (2.22, 5.44)3.47 (2.76, 4.38)1.62 (0.97)No
Mouth ulceration146.10 (3.62, 10.28)6.10 (4.67, 7.98)2.18 (1.43)Yes
Anorectal discomfort1316.62 (9.66, 28.60)16.67 (12.62, 22.03)2.97 (2.19)No
Anal pruritus1024.09 (12.96, 44.78)24.20 (17.61, 33.25)2.96 (2.08)No
Tooth loss96.58 (3.43, 12.63)6.59 (4.71, 9.20)2.07 (1.16)No
Irritable bowel syndrome83.96 (1.98, 7.91)3.96 (2.78, 5.65)1.57 (0.61)No
General disorders and administration site conditions
Oedema peripheral291.69 (1.18, 2.43)1.69 (1.40, 2.04)0.72 (0.18)Yes
Hepatobiliary disorders
Hepatic cirrhosis5627.84 (21.48, 36.08)27.98 (24.43, 32.05)4.22 (3.83)No
Hepatic failure344.96 (3.55, 6.93)4.97 (4.18, 5.90)2.14 (1.64)No
Hepatic fibrosis2340.15 (26.69, 60.38)40.46 (32.78, 49.93)3.93 (3.33)No
Hepatic function abnormal153.47 (2.09, 5.75)3.47 (2.68, 4.50)1.58 (0.85)Yes
Hepatotoxicity94.27 (2.22, 8.20)4.27 (3.06, 5.97)1.68 (0.77)Yes
Cholestatic hepatitis911.83 (6.16, 22.73)11.86 (8.49, 16.57)2.50 (1.59)No
Investigations
Platelet count decreased807.29 (5.88, 9.04)7.30 (6.51, 8.18)2.72 (2.38)Yes
White blood cell count decreased797.29 (5.87, 9.05)7.30 (6.51, 8.19)2.71 (2.38)Yes
Hemoglobin decreased725.91 (4.71, 7.42)5.92 (5.25, 6.67)2.43 (2.08)Yes
Red blood cell count decreased257.07 (4.79, 10.45)7.08 (5.79, 8.66)2.51 (1.94)Yes
Blood creatinine increased192.40 (1.53, 3.75)2.40 (1.90, 3.02)1.16 (0.51)No
Haematocrit decreased124.15 (2.36, 7.30)4.15 (3.11, 5.55)1.74 (0.93)No
Metabolism and nutrition disorders
Dehydration422.55 (1.89, 3.44)2.55 (2.18, 2.98)1.28 (0.84)Yes
Diabetes mellitus303.15 (2.20, 4.49)3.15 (2.62, 3.78)1.54 (1.02)Yes
Lactic acidosis103.18 (1.71, 5.91)3.18 (2.32, 4.37)1.41 (0.53)No
Nervous system disorders
Loss of consciousness281.77 (1.22, 2.56)1.77 (1.46, 2.14)0.78 (0.23)Yes
Dysgeusia212.18 (1.42, 3.34)2.18 (1.75, 2.71)1.04 (0.42)Yes
Cerebral infarction184.72 (2.98, 7.48)4.72 (3.73, 5.98)1.97 (1.31)Yes
Hepatic encephalopathy159.65 (5.82, 15.98)9.66 (7.46, 12.53)2.64 (1.91)No
Facial palsy1123.63 (13.09, 42.67)23.74 (17.53, 32.14)3.03 (2.19)No
Psychiatric disorders
Depression1495.32 (4.55, 6.21)5.32 (4.89, 5.79)2.29 (2.04)Yes
Insomnia812.52 (2.04, 3.12)2.52 (2.25, 2.83)1.28 (0.95)Yes
Anorexia3513.00 (9.36, 18.07)13.03 (10.99, 15.46)3.27 (2.78)Yes
Suicidal ideation302.61 (1.83, 3.72)2.61 (2.17, 3.14)1.30 (0.77)Yes
Psychotic disorder163.95 (2.42, 6.43)3.95 (3.07, 5.08)1.74 (1.04)Yes
Renal and urinary disorders
Renal impairment182.16 (1.36, 3.42)2.16 (1.70, 2.73)1.02 (0.35)Yes
Respiratory, thoracic, and mediastinal disorders
Interstitial lung disease132.32 (1.35, 3.99)2.32 (1.76, 3.07)1.08 (0.3)Yes
Hemoptysis92.63 (1.37, 5.04)2.63 (1.88, 3.67)1.17 (0.26)No
Skin and subcutaneous tissue disorders
Rash1734.22 (3.66, 4.87)4.22 (3.90, 4.57)1.96 (1.73)Yes
Pruritus1133.35 (2.80, 4.01)3.35 (3.04, 3.69)1.66 (1.38)Yes

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