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14.3.4.1

Summary of Laboratory Values: Chemistry by Visit

Made 2026-10-17 from simulated data.

ONCO-EX

Table 14.3.4.1

Summary of Laboratory Values: Chemistry by Visit

Safety Analysis Set

Standard of Care (N=150)Clinwrightinib 200 mg (N=150)
nMean (SD)Change Mean (SD)nMean (SD)Change Mean (SD)
Parameter: Sodium (mmol/L)
Baseline150139.7 (2.59)- (-)150140.3 (2.83)- (-)
Week 3146140.0 (2.94)0.3 (3.67)146140.2 (3.02)-0.1 (4.07)
Week 6145140.5 (2.52)0.8 (3.44)142140.1 (2.70)-0.2 (3.68)
Week 980140.1 (3.11)0.6 (3.88)116140.6 (3.08)0.3 (3.76)
Week 1281140.7 (2.65)1.1 (3.59)114139.7 (2.63)-0.5 (4.04)
Week 1580140.3 (2.88)0.8 (3.54)112139.8 (2.55)-0.3 (3.62)
Week 1876140.6 (2.44)1.1 (3.40)111140.3 (2.76)0.1 (3.67)
Week 2177140.7 (2.84)1.3 (4.04)103140.6 (2.64)0.3 (4.32)
Week 2479140.6 (2.84)1.0 (3.96)106140.6 (2.43)0.5 (3.54)
Week 2761141.0 (2.33)1.6 (3.27)96140.1 (2.55)0.0 (3.60)
Week 3060141.0 (3.01)1.6 (3.95)96140.4 (2.90)0.2 (4.08)
Week 3344141.3 (3.19)1.6 (3.90)80140.6 (3.05)0.4 (4.35)
Week 3645141.1 (2.46)1.5 (3.82)81140.4 (2.91)0.2 (3.98)
Week 3935141.3 (2.63)1.8 (3.30)70140.7 (3.17)0.4 (4.44)
Week 4236140.8 (2.89)1.0 (3.31)71140.4 (3.09)0.3 (3.88)
Week 4528142.1 (3.04)2.2 (3.50)62139.7 (2.50)-0.5 (3.49)
Week 4827142.2 (3.02)2.3 (3.85)62140.6 (2.92)0.3 (4.07)
End of Treatment147140.9 (2.68)1.1 (3.58)148140.2 (3.16)-0.1 (4.16)
Parameter: Potassium (mmol/L)
Baseline1504.3 (0.41)- (-)1504.3 (0.39)- (-)
Week 31484.3 (0.41)0.0 (0.51)1464.2 (0.39)-0.1 (0.51)
Week 61454.3 (0.38)0.0 (0.50)1434.3 (0.40)0.0 (0.51)
Week 9794.3 (0.38)0.1 (0.48)1164.3 (0.41)0.0 (0.51)
Week 12784.3 (0.40)0.1 (0.51)1144.3 (0.36)0.0 (0.49)
Week 15794.3 (0.43)0.1 (0.49)1134.3 (0.40)0.0 (0.49)
Week 18804.3 (0.37)0.0 (0.51)1114.2 (0.42)-0.1 (0.52)
Week 21794.3 (0.38)0.1 (0.50)1074.2 (0.42)-0.1 (0.58)
Week 24794.2 (0.41)0.0 (0.50)1064.2 (0.38)-0.1 (0.43)
Week 27594.3 (0.41)0.1 (0.48)964.3 (0.40)-0.1 (0.52)
Week 30624.2 (0.45)-0.1 (0.56)974.3 (0.36)0.0 (0.46)
Week 33444.2 (0.44)0.0 (0.43)804.2 (0.41)-0.1 (0.48)
Week 36464.4 (0.37)0.1 (0.44)814.2 (0.36)-0.1 (0.49)
Week 39354.4 (0.38)0.2 (0.55)704.2 (0.36)-0.1 (0.53)
Week 42364.3 (0.40)0.0 (0.57)714.2 (0.38)-0.1 (0.56)
Week 45274.2 (0.40)0.0 (0.54)624.2 (0.42)-0.1 (0.52)
Week 48274.3 (0.39)0.0 (0.49)624.3 (0.41)0.0 (0.50)
End of Treatment1484.3 (0.41)0.0 (0.53)1504.3 (0.39)0.0 (0.48)
Parameter: Chloride (mmol/L)
Baseline150105.9 (3.39)- (-)150104.9 (3.13)- (-)
Week 3147105.7 (3.04)-0.2 (4.42)144105.7 (3.20)0.9 (4.58)
Week 6144105.5 (3.44)-0.4 (4.58)144105.5 (2.94)0.6 (4.05)
Week 981105.3 (3.23)-0.5 (4.43)115105.3 (3.08)0.5 (4.21)
Week 1279105.9 (2.68)0.1 (4.06)112105.2 (3.29)0.3 (4.40)
Week 1580105.3 (3.31)-0.7 (4.74)114105.6 (3.09)0.8 (4.07)
Week 1880105.7 (3.25)-0.2 (4.55)110105.2 (3.51)0.3 (4.08)
Week 2179106.1 (3.49)0.2 (4.23)106105.4 (3.16)0.6 (4.08)
Week 2477105.8 (3.03)-0.1 (4.12)107105.6 (2.68)0.7 (3.81)
Week 2761106.1 (3.36)0.0 (4.14)94105.7 (3.45)1.1 (4.27)
Week 3061105.1 (3.08)-1.0 (4.25)98105.1 (3.29)0.5 (4.32)
Week 3342106.0 (3.31)0.0 (4.66)80104.6 (3.63)-0.1 (4.16)
Week 3647105.7 (3.20)-0.2 (4.11)80105.4 (2.76)0.7 (3.99)
Week 3935105.8 (3.60)-0.1 (5.47)70105.3 (2.96)0.9 (3.65)
Week 4237105.2 (3.59)-0.7 (4.14)68105.3 (3.23)1.1 (4.39)
Week 4528106.7 (3.07)1.1 (3.93)62105.1 (4.04)0.8 (4.33)
Week 4827105.5 (3.84)-0.3 (4.91)62104.6 (3.80)0.1 (4.74)
End of Treatment149105.5 (3.49)-0.5 (4.31)149104.9 (3.29)0.1 (4.40)
Parameter: Bilirubin (umol/L)
Baseline15010.0 (4.63)- (-)1509.6 (4.32)- (-)
Week 314910.1 (4.77)0.1 (3.36)14510.1 (5.10)0.5 (3.70)
Week 614610.5 (4.71)0.4 (3.19)14410.0 (5.06)0.5 (3.87)
Week 9809.4 (3.98)-0.1 (3.03)1169.8 (4.55)0.3 (3.48)
Week 128010.0 (3.81)0.4 (3.69)1129.7 (5.29)0.4 (3.22)
Week 158010.2 (5.12)0.7 (3.34)1129.3 (4.22)-0.1 (3.07)
Week 18799.9 (4.82)0.3 (4.53)1099.4 (4.09)0.2 (3.16)
Week 217810.0 (4.16)0.4 (3.94)1079.7 (4.60)0.3 (3.30)
Week 247810.2 (4.87)0.5 (3.71)1069.4 (3.94)-0.1 (3.11)
Week 276111.0 (5.12)1.0 (4.87)969.2 (4.49)-0.1 (2.85)
Week 306310.5 (3.97)0.6 (4.18)989.9 (4.26)0.6 (3.42)
Week 334412.2 (4.63)1.5 (3.58)819.6 (4.22)0.0 (3.21)
Week 364611.3 (4.22)1.0 (3.81)799.8 (4.72)0.1 (3.07)
Week 393410.9 (4.26)1.4 (4.66)709.9 (4.24)0.4 (3.72)
Week 423610.5 (3.62)1.2 (4.43)709.5 (4.31)-0.1 (3.60)
Week 452710.5 (4.04)0.9 (4.45)6110.0 (4.72)0.2 (3.77)
Week 482610.4 (3.40)1.0 (4.25)6210.0 (4.84)0.2 (3.20)
End of Treatment14810.4 (4.56)0.4 (3.43)1479.8 (4.99)0.2 (3.65)
Parameter: Alkaline Phosphatase (U/L)
Baseline15076.3 (45.78)- (-)15078.2 (45.87)- (-)
Week 314879.7 (39.71)2.9 (51.16)14573.4 (40.07)-5.0 (55.35)
Week 614382.0 (57.66)6.6 (59.99)14473.9 (42.24)-4.7 (50.37)
Week 98072.5 (29.68)-5.4 (48.78)11370.7 (38.57)-6.3 (56.03)
Week 128080.7 (43.95)2.4 (52.89)11171.0 (37.96)-7.6 (46.77)
Week 157873.2 (39.13)-3.3 (52.31)11274.1 (47.27)-2.7 (47.54)
Week 187973.2 (46.03)-4.5 (53.46)11072.6 (38.56)-4.9 (42.03)
Week 217977.2 (48.19)-0.2 (55.86)10670.4 (37.15)-7.3 (55.12)
Week 247879.1 (46.99)0.1 (53.60)10577.2 (45.10)-1.7 (58.15)
Week 276074.9 (33.13)-1.8 (48.49)9671.3 (42.74)-4.9 (47.82)
Week 306377.7 (39.23)2.0 (45.80)9871.8 (54.01)-4.2 (47.55)
Week 334366.8 (28.90)-11.6 (47.37)8177.0 (76.14)3.3 (73.28)
Week 364781.8 (40.67)4.4 (45.06)7977.4 (41.87)1.9 (44.23)
Week 393571.8 (33.51)-5.0 (47.51)7066.5 (38.27)-10.6 (45.08)
Week 423769.5 (32.45)-6.7 (53.22)7082.3 (44.83)6.4 (45.63)
Week 452871.7 (39.43)-8.5 (41.84)6280.0 (81.13)1.5 (58.95)
Week 482770.6 (29.51)-10.4 (54.84)6180.8 (45.31)3.1 (54.40)
End of Treatment14982.3 (45.37)5.9 (57.52)14876.5 (40.81)-2.2 (53.07)
Parameter: Gamma Glutamyl Transferase (U/L)
Baseline15021.8 (21.76)- (-)15023.9 (29.52)- (-)
Week 314922.2 (22.59)0.3 (18.38)14724.8 (29.35)0.8 (25.61)
Week 614321.9 (24.35)-0.7 (17.74)14326.1 (30.12)1.6 (21.04)
Week 98025.5 (26.46)1.4 (22.71)11422.2 (25.19)-3.9 (27.13)
Week 128123.0 (22.69)-1.3 (23.37)11426.9 (33.15)0.8 (31.85)
Week 158023.7 (26.87)-0.3 (20.82)11327.8 (39.49)1.7 (30.28)
Week 187921.1 (17.48)-2.7 (19.65)11024.5 (27.22)-1.4 (29.83)
Week 217823.4 (25.68)0.6 (19.62)10624.8 (27.07)-0.8 (22.79)
Week 247725.4 (26.43)1.3 (22.13)10625.1 (31.59)0.9 (25.47)
Week 276130.5 (36.18)6.5 (28.64)9721.7 (23.02)-3.2 (22.33)
Week 306223.2 (25.82)-0.8 (25.39)9625.7 (24.42)0.2 (24.94)
Week 334321.3 (16.98)-0.6 (15.38)7924.0 (26.16)-0.8 (22.09)
Week 364625.4 (22.24)3.3 (20.74)8019.8 (22.37)-4.0 (19.24)
Week 393522.5 (20.27)0.1 (15.11)6823.1 (28.13)0.6 (24.72)
Week 423726.8 (29.12)2.7 (24.14)6920.5 (28.16)-2.6 (22.02)
Week 452825.5 (22.71)-0.2 (15.95)6221.4 (23.39)-0.5 (22.00)
Week 482725.1 (19.40)0.2 (18.91)6222.0 (25.77)0.0 (18.59)
End of Treatment14723.5 (25.49)1.6 (20.75)14923.9 (26.55)-0.1 (19.84)
Parameter: Alanine Aminotransferase (U/L)
Baseline15018.6 (10.44)- (-)15017.3 (7.77)- (-)
Week 314816.8 (8.25)-1.9 (13.38)14717.5 (8.48)0.3 (10.61)
Week 614516.9 (8.39)-1.8 (13.27)14218.2 (7.81)1.1 (9.53)
Week 97917.3 (8.52)-0.9 (12.21)11318.0 (7.87)0.7 (11.07)
Week 128117.8 (9.71)-0.3 (12.28)11418.8 (9.57)1.6 (11.56)
Week 157920.9 (9.80)2.8 (12.67)11317.8 (7.42)0.7 (9.81)
Week 187917.5 (9.44)-0.6 (12.21)11017.8 (7.76)0.8 (9.93)
Week 217918.4 (11.37)0.6 (13.75)10718.7 (9.86)1.6 (11.31)
Week 247819.8 (9.23)1.7 (12.18)10818.5 (8.54)1.7 (10.13)
Week 276117.5 (9.04)-1.1 (12.69)9619.2 (9.62)2.1 (11.19)
Week 306317.7 (9.63)-1.1 (11.90)9818.5 (8.88)1.5 (11.63)
Week 334418.6 (6.59)0.2 (10.92)8119.0 (10.83)2.1 (13.36)
Week 364715.6 (6.83)-3.1 (11.56)8015.8 (6.98)-1.2 (9.66)
Week 393416.8 (6.79)-0.9 (9.55)6719.6 (10.34)2.5 (13.25)
Week 423718.6 (8.04)-0.1 (9.76)7019.7 (12.48)2.9 (14.74)
Week 452821.5 (15.41)4.1 (16.90)6119.5 (9.31)2.7 (12.30)
Week 482721.2 (10.27)3.8 (13.98)6217.9 (9.54)1.4 (11.52)
End of Treatment14917.6 (8.49)-1.1 (13.37)14818.2 (8.87)1.0 (11.15)
Parameter: Aspartate Aminotransferase (U/L)
Baseline15023.3 (6.83)- (-)15023.0 (7.89)- (-)
Week 314922.9 (6.88)-0.3 (9.53)14823.8 (7.22)0.9 (9.70)
Week 614123.5 (6.61)0.2 (9.48)14024.0 (8.56)1.1 (11.17)
Week 98123.7 (7.17)1.1 (8.91)11522.7 (8.78)0.1 (11.53)
Week 128123.9 (6.84)1.4 (9.06)11222.4 (6.93)-0.5 (9.81)
Week 158023.2 (7.15)0.5 (10.04)11122.8 (6.84)0.2 (11.00)
Week 188023.2 (6.68)0.8 (8.50)11122.4 (6.90)-0.6 (10.00)
Week 217923.1 (7.55)0.6 (8.65)10722.0 (6.17)-1.0 (9.99)
Week 247923.3 (7.23)0.7 (8.30)10722.5 (7.49)-0.5 (11.12)
Week 276125.1 (7.27)2.9 (10.38)9621.9 (8.51)-0.1 (10.04)
Week 306322.8 (6.85)0.5 (9.26)9823.1 (8.70)0.8 (10.74)
Week 334424.5 (8.62)2.6 (11.65)8023.4 (7.89)1.8 (9.93)
Week 364626.1 (9.94)4.1 (9.71)8123.1 (6.93)1.5 (9.16)
Week 393524.4 (7.36)2.3 (8.29)7023.3 (6.76)1.4 (8.52)
Week 423622.2 (6.15)0.1 (8.73)7023.3 (8.27)1.4 (10.33)
Week 452726.4 (7.57)4.1 (9.03)6221.6 (6.89)-0.9 (9.61)
Week 482725.1 (8.53)2.8 (12.18)6123.0 (7.75)0.8 (8.75)
End of Treatment14924.0 (6.75)0.7 (8.79)14923.5 (8.48)0.5 (10.89)
Parameter: Creatinine (umol/L)
Baseline150101.1 (18.48)- (-)150104.8 (19.94)- (-)
Week 3147101.2 (19.12)0.2 (15.37)146104.3 (22.06)-0.4 (14.08)
Week 6142102.5 (16.42)1.2 (14.66)144103.9 (18.45)-0.8 (14.25)
Week 981101.4 (19.22)-1.9 (14.83)116104.5 (17.89)-0.3 (14.79)
Week 1281103.8 (18.81)0.7 (15.37)109103.7 (20.98)-1.3 (16.28)
Week 1580101.5 (19.59)-2.1 (15.61)114104.8 (22.80)-0.2 (15.31)
Week 1878103.3 (17.89)0.4 (14.77)109104.1 (19.57)-1.4 (14.12)
Week 2179101.1 (16.39)-1.6 (14.90)106105.0 (20.87)-0.1 (15.51)
Week 2479101.5 (19.63)-1.7 (14.48)108106.2 (20.26)0.4 (15.30)
Week 2760103.2 (21.34)0.7 (15.00)95105.4 (20.51)0.3 (14.15)
Week 3062102.2 (19.49)-0.6 (14.73)98104.1 (20.99)-0.8 (16.52)
Week 3344105.3 (17.17)2.1 (17.29)79104.3 (19.61)-0.2 (16.48)
Week 3647100.9 (22.18)-1.7 (15.33)81103.8 (17.28)-1.9 (16.04)
Week 3934101.9 (19.28)-1.6 (16.37)69104.5 (17.82)0.0 (15.65)
Week 4237102.9 (15.80)-1.4 (13.65)71106.1 (19.54)1.0 (14.03)
Week 4528100.9 (17.59)-4.0 (14.82)62104.6 (16.05)-1.5 (14.70)
Week 4827104.1 (20.13)-0.7 (12.76)61104.2 (20.71)-1.5 (15.34)
End of Treatment149102.4 (17.23)1.3 (14.12)149105.5 (20.06)0.6 (14.11)
Parameter: Urate (umol/L)
Baseline150299.2 (75.43)- (-)150297.6 (71.46)- (-)
Week 3147293.5 (76.71)-6.0 (59.08)146297.8 (71.85)-1.0 (62.43)
Week 6143295.6 (72.11)-1.1 (56.74)143295.6 (74.36)-3.5 (60.31)
Week 981304.0 (85.71)3.1 (59.68)116300.6 (68.41)-1.4 (59.63)
Week 1281295.5 (80.68)-5.8 (56.25)113302.3 (70.91)0.4 (60.44)
Week 1580304.7 (74.53)4.2 (57.81)114303.0 (70.81)0.4 (64.53)
Week 1878307.2 (83.82)4.1 (59.49)110312.9 (71.61)12.6 (61.11)
Week 2179302.3 (86.25)0.4 (64.74)105301.6 (70.70)2.8 (60.54)
Week 2479289.2 (77.94)-11.9 (56.99)108299.1 (72.77)0.3 (66.30)
Week 2760301.6 (77.56)5.5 (59.02)96298.8 (72.58)-7.6 (58.48)
Week 3062297.4 (76.61)2.5 (56.24)98299.4 (73.86)-4.5 (63.56)
Week 3344292.7 (100.80)-8.3 (59.27)81296.8 (76.30)-4.4 (53.99)
Week 3646308.2 (89.08)-1.6 (58.48)80296.9 (69.27)-6.9 (55.55)
Week 3935298.4 (86.79)3.9 (56.26)70290.1 (74.61)-11.1 (63.71)
Week 4237296.7 (76.87)0.9 (59.79)69295.6 (78.30)-9.8 (60.05)
Week 4528327.2 (91.89)11.0 (64.53)62297.2 (68.40)-4.7 (64.35)
Week 4827319.0 (85.28)4.5 (41.23)62293.9 (56.90)-9.4 (56.79)
End of Treatment149296.3 (70.55)-2.4 (56.64)149295.8 (71.52)-2.2 (62.59)
Parameter: Phosphate (mmol/L)
Baseline1501.1 (0.15)- (-)1501.2 (0.13)- (-)
Week 31471.2 (0.13)0.0 (0.18)1451.2 (0.14)0.0 (0.18)
Week 61461.2 (0.14)0.0 (0.18)1431.2 (0.15)0.0 (0.19)
Week 9801.2 (0.15)0.0 (0.17)1161.2 (0.15)0.0 (0.19)
Week 12811.2 (0.11)0.0 (0.16)1131.2 (0.15)0.0 (0.19)
Week 15781.2 (0.14)0.0 (0.20)1141.2 (0.12)0.0 (0.18)
Week 18791.1 (0.14)0.0 (0.19)1101.2 (0.13)0.0 (0.19)
Week 21781.2 (0.15)0.0 (0.19)1061.2 (0.13)0.0 (0.16)
Week 24791.2 (0.13)0.0 (0.17)1081.2 (0.13)0.0 (0.18)
Week 27601.1 (0.14)0.0 (0.18)971.2 (0.13)0.0 (0.17)
Week 30621.1 (0.15)0.0 (0.20)981.2 (0.14)0.0 (0.19)
Week 33431.1 (0.13)0.0 (0.20)801.2 (0.14)0.0 (0.19)
Week 36461.1 (0.11)0.0 (0.16)791.2 (0.13)0.0 (0.19)
Week 39341.2 (0.14)0.0 (0.16)701.2 (0.13)0.0 (0.18)
Week 42371.2 (0.14)0.0 (0.18)711.2 (0.14)0.0 (0.19)
Week 45281.2 (0.17)0.0 (0.23)611.2 (0.15)0.0 (0.15)
Week 48271.1 (0.14)0.0 (0.19)621.2 (0.14)0.0 (0.17)
End of Treatment1501.1 (0.15)0.0 (0.20)1481.2 (0.14)0.0 (0.17)
Parameter: Calcium (mmol/L)
Baseline1502.3 (0.10)- (-)1502.3 (0.11)- (-)
Week 31482.3 (0.10)0.0 (0.14)1462.3 (0.11)0.0 (0.14)
Week 61442.3 (0.11)0.0 (0.14)1442.3 (0.10)0.0 (0.14)
Week 9802.3 (0.10)0.0 (0.15)1152.3 (0.11)0.0 (0.14)
Week 12812.3 (0.10)0.0 (0.11)1132.3 (0.10)0.0 (0.15)
Week 15802.3 (0.10)0.0 (0.12)1132.3 (0.10)0.0 (0.13)
Week 18802.3 (0.09)0.0 (0.11)1112.3 (0.11)0.0 (0.14)
Week 21792.3 (0.10)0.0 (0.14)1072.3 (0.09)0.0 (0.14)
Week 24792.3 (0.08)0.0 (0.13)1072.3 (0.11)0.0 (0.15)
Week 27602.2 (0.10)-0.1 (0.13)972.3 (0.11)0.0 (0.13)
Week 30632.3 (0.12)-0.1 (0.14)972.3 (0.10)0.0 (0.13)
Week 33432.3 (0.10)0.0 (0.14)812.3 (0.11)0.0 (0.14)
Week 36472.2 (0.11)-0.1 (0.13)812.3 (0.11)0.0 (0.13)
Week 39342.3 (0.10)0.0 (0.11)702.3 (0.10)0.0 (0.14)
Week 42362.3 (0.10)0.0 (0.12)702.3 (0.10)0.0 (0.14)
Week 45272.3 (0.11)-0.1 (0.13)612.3 (0.11)0.0 (0.14)
Week 48272.3 (0.09)-0.1 (0.09)602.3 (0.09)0.0 (0.14)
End of Treatment1492.3 (0.09)0.0 (0.12)1472.3 (0.10)0.0 (0.14)
Parameter: Glucose (mmol/L)
Baseline1505.6 (1.43)- (-)1505.5 (1.65)- (-)
Week 31455.3 (1.42)-0.3 (1.95)1475.5 (1.75)0.0 (2.19)
Week 61455.6 (1.56)0.0 (2.26)1435.4 (1.20)0.0 (1.87)
Week 9805.2 (1.30)-0.3 (1.73)1165.5 (1.73)0.1 (2.16)
Week 12795.4 (1.47)-0.2 (1.97)1135.6 (1.58)0.2 (2.19)
Week 15795.4 (1.61)-0.1 (1.99)1135.6 (1.47)0.2 (2.22)
Week 18795.4 (1.51)-0.2 (1.91)1115.4 (1.35)0.0 (2.09)
Week 21795.3 (1.28)-0.2 (2.03)1055.5 (1.43)0.1 (2.13)
Week 24785.3 (1.62)-0.3 (2.00)1075.5 (1.41)0.1 (1.93)
Week 27605.1 (1.33)-0.4 (1.89)965.5 (1.41)0.1 (2.15)
Week 30625.6 (1.84)0.1 (2.27)975.6 (1.50)0.2 (2.20)
Week 33435.2 (1.42)-0.3 (2.14)815.8 (1.49)0.4 (1.86)
Week 36475.4 (1.56)-0.2 (2.05)805.7 (1.49)0.3 (2.28)
Week 39355.6 (1.58)-0.1 (2.00)696.0 (1.66)0.7 (1.83)
Week 42375.5 (1.56)-0.1 (2.21)675.5 (1.26)0.2 (1.74)
Week 45285.8 (1.59)0.4 (1.75)616.1 (1.78)0.8 (2.42)
Week 48275.8 (1.49)0.4 (1.98)605.8 (1.53)0.5 (2.15)
End of Treatment1495.7 (1.65)0.1 (2.22)1465.6 (1.45)0.1 (2.11)
Parameter: Protein (g/L)
Baseline15069.9 (3.94)- (-)15070.4 (4.41)- (-)
Week 314670.7 (4.35)0.7 (5.10)14570.7 (4.27)0.5 (4.89)
Week 614570.6 (4.81)0.7 (5.11)14470.0 (4.40)-0.2 (5.14)
Week 98171.2 (4.14)1.1 (4.86)11469.8 (4.27)-0.3 (5.53)
Week 128070.5 (4.13)0.5 (4.45)11370.4 (4.47)0.5 (5.61)
Week 157970.5 (4.10)0.5 (4.53)11269.7 (4.34)-0.2 (5.54)
Week 188070.1 (5.04)0.0 (5.21)10970.2 (4.39)0.2 (5.38)
Week 217870.5 (4.67)0.4 (4.88)10570.8 (4.21)1.0 (5.11)
Week 247870.0 (4.76)-0.1 (5.18)10770.6 (4.38)0.6 (5.53)
Week 276070.6 (4.73)0.3 (5.32)9770.0 (4.02)0.2 (5.52)
Week 306371.1 (4.20)0.8 (4.91)9770.3 (3.88)0.6 (5.43)
Week 334369.7 (4.22)-0.1 (4.68)8070.4 (4.12)0.7 (5.19)
Week 364669.9 (5.33)0.2 (5.86)8069.3 (4.61)-0.4 (5.75)
Week 393571.1 (4.07)0.7 (4.22)7069.1 (3.81)-0.7 (5.33)
Week 423770.2 (4.43)0.1 (5.39)7169.1 (5.19)-0.6 (5.83)
Week 452770.9 (3.45)1.2 (4.29)6269.9 (3.92)0.1 (5.73)
Week 482670.0 (4.80)0.1 (4.68)6270.3 (4.18)0.5 (5.78)
End of Treatment14870.3 (4.55)0.3 (4.95)15070.2 (4.38)-0.2 (5.37)
Parameter: Albumin (g/L)
Baseline15039.8 (2.58)- (-)15039.6 (2.95)- (-)
Week 314739.7 (2.51)-0.1 (3.03)14539.9 (2.86)0.2 (3.58)
Week 614640.1 (2.76)0.3 (3.34)14239.9 (2.40)0.3 (3.31)
Week 98140.2 (3.02)0.1 (3.30)11540.1 (2.88)0.5 (3.54)
Week 128139.6 (2.25)-0.6 (3.06)11339.7 (2.68)0.2 (3.31)
Week 158039.9 (2.70)-0.3 (3.31)11339.7 (2.75)0.2 (3.23)
Week 188040.0 (2.77)-0.2 (3.37)10639.7 (2.93)0.2 (3.31)
Week 217939.6 (2.70)-0.5 (2.83)10439.8 (2.69)0.3 (3.00)
Week 247939.9 (2.89)-0.3 (3.28)10839.7 (2.69)0.4 (2.98)
Week 276139.9 (2.64)-0.5 (3.36)9739.3 (2.59)-0.3 (2.99)
Week 306339.7 (2.96)-0.8 (3.11)9739.6 (2.81)0.1 (3.41)
Week 334339.9 (2.64)-0.6 (3.75)8139.5 (2.67)0.0 (3.76)
Week 364640.3 (2.84)-0.3 (3.58)8039.3 (2.87)-0.3 (3.45)
Week 393539.4 (1.94)-1.3 (2.52)6939.4 (2.43)-0.1 (2.98)
Week 423739.4 (2.39)-1.3 (3.41)7139.0 (2.76)-0.6 (3.40)
Week 452739.4 (2.82)-1.3 (3.43)6139.8 (2.43)0.1 (3.51)
Week 482739.6 (2.79)-1.2 (3.88)6139.5 (2.88)0.0 (3.46)
End of Treatment14939.9 (2.96)0.1 (3.49)14939.8 (2.51)0.1 (3.25)
Parameter: Cholesterol (mmol/L)
Baseline1505.8 (1.07)- (-)1505.9 (1.10)- (-)
Week 31475.7 (0.88)-0.1 (0.85)1485.8 (1.04)0.0 (0.90)
Week 61435.7 (0.95)-0.1 (0.95)1445.7 (1.05)-0.2 (0.80)
Week 9805.8 (1.05)0.1 (0.87)1155.9 (1.06)-0.1 (0.79)
Week 12815.6 (0.94)-0.1 (0.96)1125.7 (1.00)-0.2 (0.82)
Week 15805.6 (0.87)-0.1 (0.87)1135.7 (1.05)-0.3 (0.79)
Week 18795.7 (0.97)-0.1 (0.85)1095.7 (1.10)-0.3 (0.89)
Week 21795.8 (0.93)0.0 (0.96)1065.7 (1.09)-0.3 (0.87)
Week 24795.7 (1.01)-0.1 (0.86)1075.6 (1.01)-0.3 (0.77)
Week 27585.8 (0.78)-0.1 (0.82)975.6 (1.06)-0.4 (0.77)
Week 30635.7 (0.91)-0.1 (0.86)975.5 (1.17)-0.5 (0.78)
Week 33435.6 (0.96)-0.1 (0.92)815.6 (1.09)-0.3 (0.78)
Week 36475.9 (0.81)0.0 (0.95)805.5 (1.06)-0.5 (0.79)
Week 39355.7 (0.93)0.0 (1.08)685.6 (1.06)-0.3 (0.77)
Week 42375.7 (0.89)-0.1 (0.79)705.5 (1.05)-0.4 (0.70)
Week 45285.8 (0.97)0.1 (0.88)615.6 (1.11)-0.3 (0.80)
Week 48275.5 (0.92)-0.2 (0.90)625.3 (1.03)-0.5 (0.82)
End of Treatment1495.7 (0.91)-0.1 (0.90)1495.5 (1.08)-0.4 (0.82)
Parameter: Creatine Kinase (U/L)
Baseline15096.7 (56.51)- (-)15096.7 (58.91)- (-)
Week 314999.6 (65.25)2.7 (80.46)146107.5 (68.44)10.6 (83.25)
Week 6146105.7 (79.02)8.4 (96.99)144103.2 (72.72)5.8 (91.88)
Week 98197.2 (52.88)0.9 (67.18)11598.8 (59.14)4.0 (75.22)
Week 1280108.8 (63.47)13.2 (77.13)11294.9 (61.14)1.0 (82.70)
Week 1580100.7 (55.16)3.8 (77.28)11498.9 (68.73)5.3 (82.71)
Week 187997.6 (53.21)0.2 (69.73)11188.9 (55.88)-8.2 (82.85)
Week 217998.7 (47.06)1.3 (66.03)10589.7 (64.30)-8.7 (88.46)
Week 2478111.2 (58.21)15.1 (80.90)10786.3 (46.12)-9.0 (72.26)
Week 2760117.6 (67.57)22.2 (73.73)9790.9 (65.60)-5.4 (84.54)
Week 3063114.5 (51.47)16.9 (72.34)9793.3 (58.02)-4.9 (81.35)
Week 3344119.5 (56.17)18.9 (73.05)8188.2 (47.44)-8.5 (77.71)
Week 3647115.1 (56.38)9.3 (87.61)80101.3 (73.07)4.7 (85.94)
Week 3935109.3 (49.54)10.4 (67.82)7092.4 (73.54)-3.3 (98.17)
Week 4237105.0 (41.58)6.4 (68.29)71101.6 (76.51)4.5 (91.76)
Week 4528106.3 (37.90)11.5 (67.36)6284.6 (50.37)-8.7 (75.09)
Week 4827110.5 (56.72)13.7 (84.26)6285.2 (57.79)-11.4 (81.47)
End of Treatment149110.4 (60.93)14.3 (87.57)15089.8 (52.32)-6.8 (70.27)

Change: from baseline.

Source: ADLBC.

Program: t-14-3-4-1.sas

Program t-14-3-4-1.sas

Version 1, written from Clinwright's patterns, 2026-10-17, checks passed.

/*==== 00-header ====*/
/*----------------------------------------------------------------------------
  Output  : Table 14.3.4.1 / Summary of Laboratory Values: Chemistry by Visit / Safety Analysis Set
  Program : t-14-3-4-1.sas   Reporting effort : CSR
  ADaM    : /work/adam (ADSL, ADLBC, ADLBH, ADVS, ADAE, ADEG, ADCM, ADMH, ADEX, ADRS, ADTR, ADTTE)
  The header and the report step follow from the shell. The sections between
  them make WORK.FINAL, one record per row of the table, in order:
    _page     the page (1 unless the output is paged); _pagelbl its heading or empty
    _ord      the row's order; _indent the label's indentation (0 = flush left)
    _rowid    the uuid of the shell row it shows (WORK._SHELL); one shell row may
              have several (a category per value); a blank row's is blank-<n>
    _kind     label | stat | blank
    rowlabel  the row's label, as text
    col1      n
    col2      Mean (SD)
    col3      Change|Mean (SD)
    col4      n
    col5      Mean (SD)
    col6      Change|Mean (SD)
  and set the big N of the column headers:
    &_bign1_3  Standard of Care|(N=xx)
    &_bign4_6  Clinwrightinib 200 mg|(N=xx)
  /work/_lib/clinwright.sas has %ls_bign, %ls_count, %ls_stats, %ls_npct, %ls_num.
----------------------------------------------------------------------------*/
libname adam "/work/adam" access=readonly;
%include "/work/_lib/clinwright.sas";
%ls_setup;

/* The shell's rows, in order, with each column's value pattern (_xx1-_xx6). */
data work._shell;
  length _page 8 _pagelbl $200 _ord 8 _indent 8 _rowid $36 _kind $5 _var $32 rowlabel $200 _xx1 $40 _xx2 $40 _xx3 $40 _xx4 $40 _xx5 $40 _xx6 $40;
  _page = 1; _pagelbl = '';
  _ord=1; _indent=0; _rowid='2c5c43d9-79de-477b-8b07-10c3128fe181'; _kind='stat'; _var='AVISIT'; rowlabel='[Visit]'; _xx1='xx'; _xx2='xx.x (xx.xx)'; _xx3='xx.x (xx.xx)'; _xx4='xx'; _xx5='xx.x (xx.xx)'; _xx6='xx.x (xx.xx)'; output;
run;

/*==== 10-data ====*/
/* Made from the output's analysis: the records of ADLBC of the subjects of ADSL with SAFFL = 'Y', by TRT01A. */
/* The population's subjects, in each column they count in. */
data work._popc;
  set adam.adsl(where=(saffl = 'Y'));
  if trt01a in ('Standard of Care') then do; _col = 1; output; end;
  if trt01a in ('Standard of Care') then do; _col = 2; output; end;
  if trt01a in ('Standard of Care') then do; _col = 3; output; end;
  if trt01a in ('Clinwrightinib 200 mg') then do; _col = 4; output; end;
  if trt01a in ('Clinwrightinib 200 mg') then do; _col = 5; output; end;
  if trt01a in ('Clinwrightinib 200 mg') then do; _col = 6; output; end;
  keep usubjid _col;
run;
data work._pop1; set adam.adsl(where=(saffl = 'Y')); keep usubjid trt01a; run;
proc sort data=work._pop1; by usubjid; run;
/* The records of ADLBC, of the population's subjects, in each column. */
proc sort data=adam.adlbc(keep=usubjid saffl avisit avisitn visit param paramn aval chg) out=work._rec; by usubjid; run;
data work._an;
  merge work._rec(in=_r) work._pop1(in=_p);
  by usubjid;
  if _r and _p;
  if trt01a in ('Standard of Care') then do; _col = 1; output; end;
  if trt01a in ('Standard of Care') then do; _col = 2; output; end;
  if trt01a in ('Standard of Care') then do; _col = 3; output; end;
  if trt01a in ('Clinwrightinib 200 mg') then do; _col = 4; output; end;
  if trt01a in ('Clinwrightinib 200 mg') then do; _col = 5; output; end;
  if trt01a in ('Clinwrightinib 200 mg') then do; _col = 6; output; end;
run;
data work._cols; do _col = 1 to 6; output; end; run;
%ls_bign(data=work._popc, trt=_col, values=1|2|3|4|5|6|1 2 3|4 5 6, names=_lsn1 _lsn2 _lsn3 _lsn4 _lsn5 _lsn6 _bign1_3 _bign4_6);

/* Subjects and records per column. */
proc sort data=work._an(keep=usubjid _col) out=work._u; by _col usubjid; run;
data work._c;
  set work._u;
  by _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; id _col; var _e; run;
data work._z; _z = 1; run;
data work._g2;
  merge work._z work._tn work._te;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  do _i = 1 to 6; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n6);
  drop _i _z;
run;
/* Per value of param: subjects and records per column. */
proc sort data=work._an(keep=usubjid _col param paramn where=(not missing(param))) out=work._u; by param _col usubjid; run;
data work._c;
  set work._u;
  by param _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep param paramn _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; by param paramn; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; by param paramn; id _col; var _e; run;
data work._g1;
  merge work._tn work._te; by param paramn;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  do _i = 1 to 6; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n6);
  drop _i;
run;
proc sort data=work._g1; by paramn param; run;
data work._g1;
  set work._g1;
  _o1 = _n_;
run;
/* Per value of param and avisit: subjects and records per column. */
proc sort data=work._an(keep=usubjid _col param avisit avisitn where=(not missing(param) and not missing(avisit))) out=work._u; by param avisit _col usubjid; run;
data work._c;
  set work._u;
  by param avisit _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep param avisit avisitn _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; by param avisit avisitn; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; by param avisit avisitn; id _col; var _e; run;
data work._g0;
  merge work._tn work._te; by param avisit avisitn;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  do _i = 1 to 6; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n6);
  drop _i;
run;
proc sort data=work._g0; by param avisitn avisit; run;
data work._g0;
  set work._g0;
  by param;
  retain _r;
  if first.param then _r = 0;
  _r = _r + 1;
  _o2 = _r;
  drop _r;
run;
proc sort data=work._g0; by param; run;
proc sort data=work._g1(keep=param _o1) out=work._gp; by param; run;
data work._g0; merge work._g0(in=_in) work._gp; by param; if _in; run;
/* [Visit] of AVISIT. */
data work._f; set work._g0; do _col = 1 to 6; output; end; run;
proc sort data=work._f; by param avisit _col; run;
%ls_stats(data=work._an, out=work._cs0, var=aval, trt=_col, by=param avisit, keepraw=Y);
data work._cs0;
  set work._cs0(rename=(_vn=_c0n _vmean=_c0mean _vsd=_c0sd _vmedian=_c0median _vq1=_c0q1 _vq3=_c0q3 _vmin=_c0min _vmax=_c0max _vcv=_c0cv _vgmean=_c0gmean _vgcv=_c0gcv _vglo=_c0glo _vghi=_c0ghi));
  keep param avisit _col _c0n _c0mean _c0sd _c0median _c0q1 _c0q3 _c0min _c0max _c0cv _c0gmean _c0gcv _c0glo _c0ghi;
run;
%ls_stats(data=work._an, out=work._cs1, var=chg, trt=_col, by=param avisit, keepraw=Y);
data work._cs1;
  set work._cs1(rename=(_vn=_c1n _vmean=_c1mean _vsd=_c1sd _vmedian=_c1median _vq1=_c1q1 _vq3=_c1q3 _vmin=_c1min _vmax=_c1max _vcv=_c1cv _vgmean=_c1gmean _vgcv=_c1gcv _vglo=_c1glo _vghi=_c1ghi));
  keep param avisit _col _c1n _c1mean _c1sd _c1median _c1q1 _c1q3 _c1min _c1max _c1cv _c1gmean _c1gcv _c1glo _c1ghi;
run;
data work._k1;
  length _rowid $36 _label _pagelbl $200 _v $200;
  merge work._f(in=_in) work._cs0 work._cs1;
  by param avisit _col;
  if _in;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  _rowid = '2c5c43d9-79de-477b-8b07-10c3128fe181';
  _page = _o1;
  _pagelbl = 'Parameter: ' || strip(param);
  _k0 = 1;
  _k1 = _o2; _k2 = 0;
  _label = strip(avisit);
  if _col = 1 then _v = strip(ifc(missing(sum(_c0n, 0)), '-', %ls_num(sum(_c0n, 0), 0)));
  else if _col = 2 then _v = strip(ifc(missing(_c0mean), '-', %ls_num(_c0mean, 1))) || ' (' || strip(ifc(missing(_c0sd), '-', %ls_num(_c0sd, 2))) || ')';
  else if _col = 3 then _v = strip(ifc(missing(_c1mean), '-', %ls_num(_c1mean, 1))) || ' (' || strip(ifc(missing(_c1sd), '-', %ls_num(_c1sd, 2))) || ')';
  else if _col = 4 then _v = strip(ifc(missing(sum(_c0n, 0)), '-', %ls_num(sum(_c0n, 0), 0)));
  else if _col = 5 then _v = strip(ifc(missing(_c0mean), '-', %ls_num(_c0mean, 1))) || ' (' || strip(ifc(missing(_c0sd), '-', %ls_num(_c0sd, 2))) || ')';
  else if _col = 6 then _v = strip(ifc(missing(_c1mean), '-', %ls_num(_c1mean, 1))) || ' (' || strip(ifc(missing(_c1sd), '-', %ls_num(_c1sd, 2))) || ')';
  keep _rowid _label _page _pagelbl _k0 _k1 _k2 _col _v;
run;

data work._cells; set work._k1; run;
proc sort data=work._cells; by _page _pagelbl _k0 _k1 _k2 _rowid _label _col; run;
proc transpose data=work._cells out=work._wide(drop=_name_) prefix=col;
  by _page _pagelbl _k0 _k1 _k2 _rowid _label;
  id _col;
  var _v;
run;
proc sort data=work._wide; by _rowid; run;
proc sort data=work._shell(drop=_page _pagelbl) out=work._rows; by _rowid; run;
data work._inst;
  merge work._wide(in=_w) work._rows(in=_s);
  by _rowid;
  if _w and _s;
  if _label ne '' then rowlabel = _label;
run;
data work._fixed;
  set work._shell;
  if _rowid not in ('2c5c43d9-79de-477b-8b07-10c3128fe181');
  _k0 = _ord; _k1 = 0; _k2 = 0;
run;
data work.final;
  length col1 col2 col3 col4 col5 col6 $200 _pagelbl $200;
  set work._inst work._fixed;
run;
proc sort data=work.final; by _page _k0 _k1 _k2; run;
data work.final;
  set work.final;
  _ord = _n_;
  keep _page _pagelbl _ord _indent _rowid _kind rowlabel col1 col2 col3 col4 col5 col6;
run;

/*==== 90-report ====*/
/* 90-report: from the shell; the titles, columns, headers and footnotes are not changed here. */
%ls_need(_bign1_3 _bign4_6);
%ls_final_check(columns=_page _pagelbl _ord _indent _rowid _kind rowlabel col1 col2 col3 col4 col5 col6);
proc sort data=work.final out=work._report; by _page _ord; run;
data work._report;
  set work._report;
  /* Two spaces per step of indentation: the label column keeps leading spaces (asis=on). */
  if _indent > 0 then rowlabel = repeat(' ', 2 * _indent - 1) || rowlabel;
run;
%let _lspaged = 0;
proc sql noprint; select count(*) into :_lspaged trimmed from work._report where _pagelbl ne ''; quit;

options orientation=landscape;
ods listing close;
ods rtf file="/work/out/t-14-3-4-1.rtf" style=journal;
title1 j=l "ONCO-EX" j=r "Page ~{thispage} of ~{lastpage}";
title2 j=c "Table 14.3.4.1";
title3 j=c "Summary of Laboratory Values: Chemistry by Visit";
title4 j=c "Safety Analysis Set";
footnote1 j=l "Change: from baseline.";
footnote2 j=l "Source: ADLBC.";
footnote3 j=l "Program: t-14-3-4-1.sas";
%macro _ls_report;
proc report data=work._report nowd split='|' missing style(report)={width=100%};
  column _page _pagelbl _ord _indent _kind rowlabel ("Standard of Care|(N=&_bign1_3.)" col1 col2 col3) ("Clinwrightinib 200 mg|(N=&_bign4_6.)" col4 col5 col6);
  define _page / order order=internal noprint;
  define _pagelbl / order noprint;
  define _ord / order order=internal noprint;
  define _indent / display noprint;
  define _kind / display noprint;
  define rowlabel / display "" style(column)={cellwidth=40% asis=on} style(header)={just=l};
  define col1 / display "n" style(column)={cellwidth=10% just=c} style(header)={just=c};
  define col2 / display "Mean (SD)" style(column)={cellwidth=10% just=c} style(header)={just=c};
  define col3 / display "Change|Mean (SD)" style(column)={cellwidth=10% just=c} style(header)={just=c};
  define col4 / display "n" style(column)={cellwidth=10% just=c} style(header)={just=c};
  define col5 / display "Mean (SD)" style(column)={cellwidth=10% just=c} style(header)={just=c};
  define col6 / display "Change|Mean (SD)" style(column)={cellwidth=10% just=c} style(header)={just=c};
  %if &_lspaged > 0 %then %do;
  compute before _pagelbl / style={just=l};
    line _pagelbl $200.;
  endcomp;
  %end;
  break after _page / page;
run;
%mend _ls_report;
%_ls_report;
ods rtf close;
ods listing;
%ls_final_export;