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. Author manuscript; available in PMC: 2020 Sep 25.
Published in final edited form as: Eur Urol. 2018 May 18;74(5):611–620. doi: 10.1016/j.eururo.2018.05.002

Table 2 -.

Pooled odds ratio estimates of serious adverse events (grade III–IV) within three randomized controlled trials of adjuvant targeted therapy for localized renal cell carcinoma

Study TKI OR (95% CI) p value
Decreased appetite
ASSURE Sorafenib 11.05 (0.61–200.312) 0.104
ASSURE Sunitinib 25.53 (1.51–432.13) 0.025
PROTECT Pazopanib 1.97 (0.18–21.77) 0.581
S-TRAC Sunitinib 5.00 (0.24–104.58) 0.300
Pooled ORfixed (95% CI) 6.49 (1.63–25.78) 0.008
Pooled ORrandom (95% CI) 6.49 (1.63–25.78) 0.008
Diarrhea
ASSURE Sorafenib 21.13 (6.58–67.81) <0.001
ASSURE Sunitinib 22.87 (7.14–73.26) <0.001
S-TRAC Sunitinib 12.37(1.60–95.71) 0.016
PROTECT Pazopanib 9.93 (3.52–28.01) <0.001
S-TRAC Sunitinib 12.37 (1.60–95.71) 0.016
Pooled ORfixed (95% CI) 15.79 (8.53–29.19) <0.001
Pooled ORrandom (95% CI) 15.79 (8.53–29.19) <0.001
Dyspepsia
ASSURE Sorafenib 6.03 (0.72–50.22) 0.097
ASSURE Sunitinib 15.37 (2.02–116.71) 0.008
PROTECT Pazopanib NR -
S-TRAC Sunitinib 9.06 (0.49–168.99) 0.140
Pooled ORfixed (95% CI) 9.67 (2.61–35.84) 0.001
Pooled ORrandom (95% CI) 9.67 (2.61–35.84) 0.001
Fatigue
ASSURE Sorafenib 2.41 (1.39–4.17) 0.002
ASSURE Sunitinib 6.82 (4.14–11.26) <0.001
PROTECT Pazopanib 3.24 (1.05–10.01) 0.041
S-TRAC Sunitinib 3.87 (1.27–11.79) 0.017
Pooled ORfixed (95% CI) 4.12 (2.94–5.76) <0.001
Pooled ORrandom (95% CI) 3.90 (2.14–4.44) <0.001
Headache
ASSURE Sorafenib 6.03 (0.72–50.22) 0.097
ASSURE Sunitinib 8.10 (1.01–64.99) 0.049
PROTECT Pazopanib 1.97 (0.18–21.77) 0.581
S-TRAC Sunitinib 5.00 (0.24–104.58) 0.300
Pooled ORfixed (95% CI) 4.94 (1.54–15.88) 0.007
Pooled ORrandom (95% CI) 4.94 (1.54–15.88) 0.007
Hand-food syndrome
ASSURE Sorafenib 43.79 (20.41–93.95) <0.001
ASSURE Sunitinib 15.65 (7.20–34.03) <0.001
PROTECT Pazopanib NR -
S-TRAC Sunitinib 57.77 (7.92–421.28) <0.001
Pooled ORfixed (95% CI) 27.90 (16.50–47.17) <0.001
Pooled ORrandom (95% CI) 29.27 (12.87–66.57) <0.001
Hypertension
ASSURE Sorafenib 4.48 (2.86–6.99) <0.001
ASSURE Sunitinib 4.66 (2.99–7.27) <0.001
PROTECT Pazopanib 4.65 (3.17–6.83) <0.001
S-TRAC Sunitinib 2.13 (0.72–6.28) 0.172
Pooled ORfixed (95% CI) 4.43 (3.50–5.62) <0.001
Pooled ORrandom (95% CI) 4.43 (3.50–5.62) <0.001
Mucositis/stomatitis
ASSURE Sorafenib 14.25 (1.87–108.70) 0.010
ASSURE Sunitinib 26.04 (3.52–192.79) 0.001
PROTECT Pazopanib 4.93 (0.24–102.91) 0.304
S-TRAC Sunitinib 45.86 (2.77–760.62) 0.008
Pooled ORfixed (95% CI) 18.35 (5.68–59.29) <0.001
Pooled ORrandom (95% CI) 18.35 (5.68–59.29) <0.001
Nausea
ASSURE Sorafenib 8.07 (1.01–64.67) 0.049
ASSURE Sunitinib 23.88 (3.22–177.37) 0.002
PROTECT Pazopanib 4.93 (0.24–102.91) 0.304
S-TRAC Sunitinib 13.17 (0.74–234.87) 0.079
Pooled ORfixed (95% CI) 11.904 (3.63–39.06) <0.001
Pooled ORrandom (95% CI) 11.904 (3.63–39.06) <0.001
Neutropenia/infection
ASSURE Sorafenib 2.39 (1.20–4.74) 0.013
ASSURE Sunitinib 1.52 (0.73–3.18) 0.269
PROTECT Pazopanib NR NR
S-TRAC Sunitinib 57.54 (3.49–948.54) 0.005
Pooled ORfixed (95% CI) 2.15 (1.31–3.53) 0.002
Pooled ORrandom (95% CI) 2.80 (0.98–7.97) 0.054
Vomiting
ASSURE Sorafenib 3.52 (0.73–17.00) 0.118
ASSURE Sunitinib 7.15 (1.62–31.59) 0.009
PROTECT Pazopanib 0.98 (0.06–15.74) 0.990
S-TRAC Sunitinib 15.25 (0.87–268.21) 0.063
Pooled ORfixed (95% CI) 4.76 (1.84–12.30) 0.001
Pooled ORrandom (95% CI) 4.76 (1.842–12.30) 0.001

CI = confidence interval; NR = not reported; OR = odds ratio; TKI = tyrosine kinase inhibitors.