Table 3.
Signal strength of reports of niraparib at the preferred term (PT) level in FAERS database.
| SOC | Preferred terms (PTs) | Niraparib cases reporting PT | ROR (95% two-sided Cl) | PRR (χ2) | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Anaemia | 772 | 8.52 (7.91–9.17) | 8.02 (4723.29) | 2.97 (2.87) | 7.93 (7.37) |
| Thrombocytopenia | 606 | 11.02 (10.15–11.97) | 10.50 (5148.09) | 3.35 (3.22) | 10.34 (9.52) | |
| Lymphadenopathy | 127 | 7.18 (6.02–8.56) | 7.11 (660.38) | 2.74 (2.48) | 7.04 (5.91) | |
| Pancytopenia | 124 | 4.53 (3.80–5.42) | 4.50 (335.57) | 2.11 (1.85) | 4.47 (3.74) | |
| Cardiac disorders | Palpitations | 361 | 6.21 (5.59–6.90) | 6.05 (1514.14) | 2.56 (2.41) | 6.00 (5.40) |
| Tachycardia | 121 | 2.58 (2.15–3.08) | 2.56 (115.10) | 1.32 (1.06) | 2.55 (2.13) | |
| Gastrointestinal disorders | Nausea | 3459 | 11.59 (11.14–12.06) | 8.46 (23,269.91) | 3.06 (3.00) | 8.36 (8.03) |
| Constipation | 2499 | 27.71 (26.50–28.99) | 22.01 (48,882.17) | 4.40 (4.34) | 21.29 (20.35) | |
| Vomiting | 1245 | 5.79 (5.46–6.14) | 5.28 (4374.92) | 2.39 (2.30) | 5.25 (4.95) | |
| Abdominal pain upper | 534 | 5.14 (4.71–5.61) | 4.95 (1686.01) | 2.29 (2.16) | 4.92 (4.51) | |
| Abdominal discomfort | 525 | 5.46 (5.00–5.97) | 5.26 (1813.06) | 2.37 (2.24) | 5.23 (4.79) | |
| Dry mouth | 521 | 14.18 (12.97–15.49) | 13.59 (5965.45) | 3.70 (3.57) | 13.32 (12.19) | |
| Abdominal pain | 396 | 3.44 (3.11–3.80) | 3.36 (659.03) | 1.73 (1.58) | 3.35 (3.03) | |
| Dyspepsia | 385 | 8.41 (7.59–9.31) | 8.16 (2398.36) | 2.98 (2.83) | 8.07 (7.29) | |
| Stomatitis | 332 | 10.06 (9.01–11.23) | 9.80 (2591.38) | 3.23 (3.07) | 9.67 (8.66) | |
| Abdominal distension | 309 | 5.98 (5.34–6.69) | 5.85 (1234.99) | 2.51 (2.34) | 5.80 (5.18) | |
| Intestinal obstruction | 230 | 11.51 (10.09–13.13) | 11.30 (2124.80) | 3.41 (3.21) | 11.12 (9.75) | |
| Flatulence | 216 | 7.74 (6.76–8.86) | 7.61 (1228.92) | 2.86 (2.66) | 7.53 (6.58) | |
| Gastrooesophageal reflux disease * | 175 | 4.38 (3.77–5.09) | 4.33 (446.61) | 2.07 (1.85) | 4.31 (3.71) | |
| Dysphagia | 169 | 3.55 (3.05–4.14) | 3.52 (303.79) | 1.78 (1.55) | 3.50 (3.01) | |
| Ascites | 158 | 10.64 (9.08–12.46) | 10.51 (1338.52) | 3.28 (3.05) | 10.35 (8.83) | |
| Retching | 156 | 15.28 (13.03–17.93) | 15.09 (2005.82) | 3.75 (3.52) | 14.76 (12.58) | |
| Oral pain | 110 | 9.36 (7.75–11.31) | 9.28 (801.80) | 3.08 (2.80) | 9.16 (7.58) | |
| General disorders and administration site conditions | Fatigue | 3075 | 9.11 (8.75–9.50) | 6.98 (16,200.15) | 2.79 (2.73) | 6.92 (6.64) |
| Asthenia | 1158 | 6.48 (6.10–6.89) | 5.94 (4791.56) | 2.55 (2.46) | 5.89 (5.54) | |
| Malaise | 670 | 2.69 (2.49–2.91) | 2.60 (670.55) | 1.37 (1.25) | 2.59 (2.40) | |
| Adverse drug reaction | 595 | 12.40 (11.41–13.48) | 11.82 (5807.91) | 3.51 (3.39) | 11.62 (10.69) | |
| Disease progression | 593 | 12.00 (11.04–13.04) | 11.44 (5574.21) | 3.47 (3.34) | 11.25 (10.35) | |
| Feeling abnormal * | 557 | 4.35 (3.99–4.74) | 4.19 (1358.61) | 2.05 (1.92) | 4.17 (3.83) | |
| Peripheral swelling | 259 | 2.43 (2.15–2.75) | 2.40 (213.07) | 1.25 (1.07) | 2.40 (2.12) | |
| Drug intolerance | 228 | 3.49 (3.06–3.98) | 3.44 (394.47) | 1.75 (1.56) | 3.43 (3.00) | |
| Ill-defined disorder | 179 | 6.65 (5.73–7.71) | 6.56 (836.56) | 2.65 (2.43) | 6.50 (5.60) | |
| Illness | 175 | 5.01 (4.31–5.82) | 4.95 (548.93) | 2.26 (2.04) | 4.92 (4.23) | |
| Unevaluable event | 131 | 3.08 (2.59–3.66) | 3.06 (181.42) | 1.58 (1.32) | 3.05 (2.57) | |
| Decreased activity | 116 | 21.91 (18.19–26.39) | 21.70 (2214.14) | 4.15 (3.88) | 21.00 (17.43) | |
| Infections and infestations | Urinary tract infection | 340 | 3.71 (3.33–4.13) | 3.63 (648.91) | 1.84 (1.68) | 3.61 (3.24) |
| Nasopharyngitis | 238 | 2.47 (2.17–2.81) | 2.44 (202.96) | 1.27 (1.08) | 2.43 (2.14) | |
| Investigations | Platelet count decreased | 2330 | 54.14 (51.67–56.72) | 43.56 (90,943.01) | 5.32 (5.26) | 40.75 (38.90) |
| Blood pressure increased | 1346 | 18.25 (17.24–19.33) | 16.27 (18,932.10) | 3.97 (3.89) | 15.88 (14.99) | |
| Carbohydrate antigen 125 increased | 1331 | 1067.22 (977.68–1164.95) | 945.93 (496,419.82) | 8.19 (8.09) | 374.25 (342.85) | |
| Haemoglobin decreased | 1051 | 22.78 (21.36–24.29) | 20.82 (19,269.58) | 4.31 (4.21) | 20.17 (18.92) | |
| White blood cell count decreased | 823 | 14.70 (13.68–15.79) | 13.73 (9554.34) | 3.73 (3.62) | 13.46 (12.53) | |
| Red blood cell count decreased | 812 | 61.48 (57.08–66.23) | 57.29 (41,149.29) | 5.62 (5.52) | 52.51 (48.75) | |
| Heart rate increased | 699 | 15.29 (14.15–16.52) | 14.43 (8575.94) | 3.79 (3.68) | 14.13 (13.08) | |
| Weight decreased | 641 | 4.39 (4.06–4.76) | 4.21 (1578.02) | 2.06 (1.94) | 4.19 (3.87) | |
| Blood count abnormal | 462 | 26.7 (24.28–29.35) | 25.68 (10,538.43) | 4.55 (4.41) | 24.7 (22.46) | |
| Blood creatinine increased | 366 | 11.67 (10.50–12.96) | 11.33 (3395.41) | 3.44 (3.28) | 11.15 (10.04) | |
| Laboratory test abnormal | 304 | 14.94 (13.31–16.76) | 14.58 (3762.72) | 3.77 (3.60) | 14.26 (12.71) | |
| Haematocrit decreased | 262 | 30.32 (26.75–34.37) | 29.67 (6930.65) | 4.68 (4.49) | 28.35 (25.01) | |
| Full blood count decreased | 229 | 19.69 (17.24–22.49) | 19.32 (3862.25) | 4.12 (3.92) | 18.77 (16.43) | |
| Neutrophil count decreased | 185 | 9.13 (7.89–10.57) | 9.00 (1299.47) | 3.08 (2.87) | 8.89 (7.68) | |
| Tumour marker increased | 183 | 62.72 (53.82–73.10) | 61.76 (9947.24) | 5.43 (5.20) | 56.24 (48.25) | |
| Blood potassium decreased * | 167 | 11.20 (9.60–13.07) | 11.06 (1502.89) | 3.35 (3.13) | 10.88 (9.33) | |
| Blood magnesium decreased | 158 | 35.06 (29.84–41.20) | 34.60 (4884.26) | 4.76 (4.53) | 32.82 (27.93) | |
| Eastern Cooperative Oncology Group performance status worsened | 133 | 248.74 (203.29–304.36) | 245.93 (23,204.79) | 6.24 (5.96) | 176.17 (143.98) | |
| Computerised tomogram abnormal | 101 | 145.98 (117.45–181.43) | 144.73 (11,680) | 5.76 (5.45) | 117.44 (94.49) | |
| Metabolism and nutrition disorders | Decreased appetite | 1176 | 10.19 (9.59–10.83) | 9.27 (8639.33) | 3.18 (3.09) | 9.14 (8.61) |
| Dehydration | 393 | 6.33 (5.73–7.01) | 6.16 (1689.59) | 2.59 (2.44) | 6.1 (5.52) | |
| Musculoskeletal and connective tissue disorders | Arthralgia | 678 | 3.31 (3.07–3.58) | 3.18 (1026.84) | 1.66 (1.54) | 3.17 (2.93) |
| Back pain | 490 | 4.09 (3.74–4.48) | 3.96 (1089.14) | 1.97 (1.83) | 3.94 (3.60) | |
| Pain in extremity | 391 | 2.57 (2.32–2.84) | 2.52 (360.79) | 1.32 (1.17) | 2.51 (2.27) | |
| Myalgia | 292 | 3.39 (3.02–3.81) | 3.33 (477.10) | 1.71 (1.54) | 3.32 (2.95) | |
| Muscle spasms | 276 | 2.90 (2.58–3.27) | 2.86 (334.64) | 1.50 (1.32) | 2.85 (2.53) | |
| Muscular weakness | 167 | 2.98 (2.56–3.48) | 2.96 (216.03) | 1.53 (1.31) | 2.95 (2.53) | |
| Bone pain | 160 | 5.08 (4.34–5.94) | 5.02 (512.91) | 2.28 (2.04) | 4.99 (4.27) | |
| Arthritis | 122 | 2.96 (2.48–3.54) | 2.94 (156.24) | 1.52 (1.25) | 2.93 (2.45) | |
| Nervous system disorders | Headache | 1318 | 4.19 (3.96–4.44) | 3.83 (2823.61) | 1.93 (1.84) | 3.81 (3.60) |
| Dizziness | 905 | 3.75 (3.50–4.01) | 3.54 (1673.98) | 1.81 (1.71) | 3.52 (3.29) | |
| Neuropathy peripheral * | 649 | 12.93 (11.94–14.01) | 12.27 (6616.89) | 3.56 (3.45) | 12.05 (11.12) | |
| Hypoaesthesia | 235 | 3.16 (2.77–3.59) | 3.11 (337.60) | 1.61 (1.42) | 3.10 (2.73) | |
| Balance disorder * | 220 | 4.83 (4.23–5.53) | 4.76 (651.15) | 2.21 (2.01) | 4.73 (4.14) | |
| Tremor | 215 | 2.54 (2.22–2.91) | 2.51 (196.32) | 1.31 (1.11) | 2.51 (2.19) | |
| Dysgeusia | 213 | 7.00 (6.11–8.02) | 6.89 (1063.97) | 2.73 (2.53) | 6.83 (5.96) | |
| Memory impairment * | 205 | 2.58 (2.25–2.96) | 2.55 (193.94) | 1.33 (1.13) | 2.55 (2.22) | |
| Taste disorder | 174 | 16.26 (13.97–18.92) | 16.03 (2392.61) | 3.84 (3.62) | 15.65 (13.45) | |
| Psychiatric disorders | Insomnia | 1722 | 14.50 (13.77–15.27) | 12.51 (18,093.9) | 3.61 (3.53) | 12.28 (11.67) |
| Anxiety | 554 | 3.59 (3.30–3.91) | 3.47 (981.34) | 1.78 (1.65) | 3.45 (3.17) | |
| Emotional distress * | 429 | 5.15 (4.68–5.68) | 5.00 (1372.11) | 2.30 (2.15) | 4.97 (4.51) | |
| Sleep disorder | 330 | 8.94 (8.01–9.98) | 8.72 (2230.66) | 3.07 (2.91) | 8.61 (7.71) | |
| Stress | 171 | 4.56 (3.92–5.31) | 4.51 (465.39) | 2.13 (1.90) | 4.49 (3.85) | |
| Nervousness | 125 | 4.89 (4.10–5.84) | 4.85 (379.83) | 2.21 (1.95) | 4.82 (4.04) | |
| Middle insomnia | 110 | 13.52 (11.18–16.35) | 13.40 (1236.51) | 3.55 (3.27) | 13.14 (10.87) | |
| Renal and urinary disorders | Renal impairment | 320 | 6.65 (5.95–7.44) | 6.50 (1479.45) | 2.66 (2.49) | 6.44 (5.76) |
| Renal disorder | 100 | 3.78 (3.10–4.60) | 3.75 (201.25) | 1.85 (1.56) | 3.74 (3.07) | |
| Respiratory, thoracic and mediastinal disorders | Dyspnoea | 859 | 2.92 (2.73–3.13) | 2.78 (1001.66) | 1.47 (1.36) | 2.77 (2.59) |
| Cough | 425 | 2.85 (2.58–3.14) | 2.78 (488.14) | 1.46 (1.32) | 2.77 (2.51) | |
| Oropharyngeal pain | 206 | 4.26 (3.71–4.89) | 4.20 (501.03) | 2.03 (1.83) | 4.18 (3.64) | |
| Dyspnoea exertional | 160 | 7.15 (6.11–8.37) | 7.07 (825.90) | 2.75 (2.51) | 7.00 (5.98) | |
| Epistaxis | 153 | 3.57 (3.04–4.19) | 3.54 (277.98) | 1.78 (1.55) | 3.52 (3.00) | |
| Rhinorrhoea | 149 | 4.09 (3.48–4.81) | 4.05 (340.73) | 1.97 (1.73) | 4.03 (3.42) | |
| Pleural effusion | 113 | 3.61 (3.00–4.34) | 3.58 (209.74) | 1.79 (1.52) | 3.57 (2.96) | |
| Skin and subcutaneous tissue disorders | Photosensitivity reaction * | 204 | 23.58 (20.48–27.15) | 23.19 (4177.97) | 4.33 (4.13) | 22.39 (19.44) |
| Hyperhidrosis | 167 | 2.59 (2.22–3.02) | 2.57 (160.02) | 1.33 (1.11) | 2.56 (2.20) | |
| Vascular disorders | Hypertension | 715 | 7.14 (6.62–7.71) | 6.77 (3509.00) | 2.73 (2.62) | 6.71 (6.21) |
| Hot flush | 219 | 5.98 (5.23–6.84) | 5.89 (882.89) | 2.51 (2.31) | 5.84 (5.11) | |
| Blood pressure fluctuation | 164 | 9.74 (8.34–11.38) | 9.62 (1248.94) | 3.16 (2.94) | 9.49 (8.12) | |
| Thrombosis | 112 | 2.61 (2.17–3.15) | 2.60 (109.78) | 1.34 (1.06) | 2.59 (2.15) |
*Emerging findings of niraparib associated AEs from FAERS database. ROR reporting odds ratio; CI confidence interval; PRR proportional reporting ratio; χ chi-squared; IC information component; IC025 the lower limit of 95% CI of the IC; EBGM empirical Bayesian geometric mean; EBGM05 the lower limit of 95% CI of EBGM.