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Table 6 Parameter estimates from the joint multivariate continuous longitudinal clinical laboratory, paracetamol concomitant medication count and AE count model

From: Joint modelling of multivariate longitudinal clinical laboratory safety outcomes, concomitant medication and clinical adverse events: application to artemisinin-based treatment during pregnancy clinical trial

Variable

Coefficient (SE)

95% Confidence interval

P-value

Log alanine amino transferase longitudinal sub-model

 Maternal age

0.0006 (0.0023)

−0.0040, 0.0051

0.810

 Treatment

  ASAQ

−0.0016 (0.0276)

−0.0557, 0.0525

0.953

  DHAPQ

0.0031 (0.0275)

−0.0508, 0.0570

0.909

 Second trimester

−0.0223 (0.0311)

−0.0833, 0.0387

0.474

 Constant

2.8236 (0.0608)

2.7043, 2.9428

< 0.001

Log total bilirubin longitudinal sub-model

 Maternal age

−0.0027 (0.0034)

−0.0094, 0.0039

0.418

 Treatment

  ASAQ

−0.0346 (0.0419)

−0.1168, 0.0476

0.409

  DHAPQ

−0.0483 (0.0416)

−0.1299, 0.0334

0.246

 Second trimester

−0.1747 (0.0471)

−0.2669, − 0.0824

< 0.001

 Constant

2.3118 (0.0911)

2.1394, 2.4966

< 0.001

Concomitant medication count sub-model

 Maternal age

0.0144 (0.0088)

−0.0030, 0.0318

0.103

 Treatment

  ASAQ

−0.3469 (0.1068)

−0. 5563, − 0. 1376

0.001

  DHAPQ

−0.2850 (0.1046)

− 0.4901, − 0.0798

0.006

 Second trimester

0.3850 (0.1273)

0.1355, 0.6344

0.002

 Constant

−0.6712 (0.2385)

−1.1387, − 0.2038

0.005

Adverse events count sub-model

 Maternal age

0.0161 (0.0092)

0.0019, 0.0340

0.079

 Treatment

  ASAQ

0.1687 (0.1099)

0.0466, 0.3840

0.125

  DHAPQ

−0.0876 (0.1103)

− 0.3038, 0.1286

0.427

 Second trimester

0.3986 (0.1270)

0.1497, 0.6474

0.002

  αlog(ALT)

0.0016 (0.2392)

−0.4673, 0.4704

0.995

  αlog(bilirubin)

0.0218 (0.1207)

−0.2148, 0.2585

0.856

  αconcmed

1.2969 (0.0837)

1.1328, 1.4609

< 0.001

  Constant

−0.6805 (0.7793)

−2.2079, 0.8469

0.383

Patient-specific random effects standard deviations

 Standard deviations

  δlog(ALT)

0.2555 (0.0119)

0.2331, 0.2800

 

  δlog(bilirubin)

0.5028 (0.0153)

0.4736, 0.5338

 

  δlog(concmed)

0.7931 (0.0480)

0.7043, 0.8931

 
  1. ALT Alanine aminotransferase, concmed Paracetamol concomitant medication