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Table 5 Parameter estimates from the joint multivariate longitudinal clinical laboratory, concomitant medication and AE counts 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)

− 0.00394, 0.0052

0.793

 Treatment

  ASAQ

− 0.0036 (0.0275)

−0.0575, 0.0504

0.897

  DHAPQ

0.0031 (0.0275)

−0.0508, 0.0570

0.909

 Second trimester

−0.0212 (0.0311)

− 0.0820, 0.0397

0.496

 Constant

2.8221 (0.0609)

2.7027, 2.9415

< 0.001

Log total bilirubin longitudinal sub-model

 Maternal age

−0.0026 (0.0035)

−0.0095, 0.0043

0.464

 Treatment

  ASAQ

−0.0229 (0.0424)

−0.1059, 0.0601

0.589

  DHAPQ

−0.0413 (0.0422)

−0.1240, 0.0414

0.328

 Second trimester

−0.1786 (0.0493)

−0.2752, − 0.0820

< 0.001

 Constant

2.3103 (0.0963)

2.1216, 2.4990

< 0.001

Concomitant medication count sub-model

 Maternal age

0.0086 (0.0052)

−0.0017, 0.0189

0.101

 Treatment

  ASAQ

−0.1841 (0.0619)

−0.3054, − 0.0629

0.003

  DHAPQ

−0.1723 (0.0610)

− 0.2918, − 0.0528

0.005

 Second trimester

0.2861 (0.0718)

0.1454, 0.4268

< 0.001

 Constant

0.9147 (0.1395)

0.6414, 1.188

< 0.001

Adverse events count sub-model

 Maternal age

0.0189 (0.0088)

0.0017, 0.0362

0.031

 Treatment

  ASAQ

0.2118 (0.1039)

0.0082, 0.4154

0.041

  DHAPQ

−0.0508 (0.1046)

−0.2559, 0.1542

0.627

 Second trimester

0.3986 (0.1222)

0.1592, 0.6381

0.001

  αlog(ALT)

− 0.0288 (0.2427)

− 0.5045, 0.4469

0.906

  αlog(bilirubin)

0.1153 (0.1042)

− 0.0889, 0.3194

0.269

  αconcmed

1.7487 (0.1029)

1.5471, 1.9503

< 0.001

  Constant

−0.8220 (0.7739)

−2.3388, 0.6949

0.288

Patient-specific random effects standard deviations

 Standard deviations

  δlog(ALT)

0.2547 (0.0119)

0.2324, 0.2792

 

  δlog(bilirubin)

0.5025 (0.0154)

0.4732, 0.5336

 

  δlog(concmed)

0.5378 (0.0248)

0.4914, 0.5887

 
  1. ALT Alanine aminotransferase, concmed Concomitant medication