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Table 6 HIGH clinical trial: Detection of treatmen-by-subset interaction when K=2

From: Enrichment Bayesian design for randomized clinical trials using categorical biomarkers and a binary outcome

 

Interaction method

\(\boldsymbol {\widehat {\theta }}\) global CI95%

\(\boldsymbol {\widehat {\theta _{A}}}\) CI95%

\(\boldsymbol {\widehat {\theta _{B}}}\) CI95%

Decision

nA

nB

Probability of interaction effect*

Age Partition

Age≥65

Age<65

    

1er interim analysis

Millen

 

1.228[0.721-1.988]

0.913[0.548-1.412]

Go with entire population

87

107

0.56

 

Gail and Simon

 

1.228[0.721-1.988]

0.913[0.548-1.412]

Go with entire population

87

107

0.02& 0.09

2nd interim analysis

Millen

 

1.367[0.931-1.957]

0.868[0.586-1.241]

Go with entire population

178

210

0.80

 

Gail and Simon

 

1.367[0.931-1.957]

0.868[0.586-1.241]

Go with entire population

178

210

0.02& 0.08

3th interim analysis

Millen

 

1.184[0.879-1.568]

0.745[0.529-1.011]

Go with entire population

265

320

0.85

 

Gail and Simon

 

1.184[0.879-1.568]

0.745[0.529-1.011]

Go with entire population

265

320

0.01& 0.00

Final analysis

Millen

0.989[0.819-1.182]

1.245[0.956-1.597]

0.780[0.580-1.017]

Go with entire population

360

416

0.9

 

Gail and Simon

0.989[0.819-1.182]

1.245[0.956-1.597]

0.780[0.580-1.017]

Go with entire population

360

416

0.01& 0.00

SOFA neurological Partition

SOFA neuro≥1

SOFA neuro<1

    

1er interim analysis

Millen

 

0.799[0.391-1.349]

1.136[0.750-1.655]

Go with entire population

27

167

0.66

 

Gail and Simon

 

0.799[0.391-1.349]

1.136[0.750-1.655]

Go with entire population

27

167

0.02& 0.02

2nd interim analysis

Millen

 

0.633[0.341-1.026]

1.252[0.916-1.677]

Enrichment in subset A

54

334

0.94

 

Gail and Simon

 

0.633[0.341-1.026]

1.252[0.916-1.677]

Enrichment in subset A

54

334

0.08& 0.00

3th interim analysis

Millen

 

0.753[0.477-1.107]

1.252[0.916-1.679]

Enrichment in subset A

77

334

–

 

Gail and Simon

 

0.753[0.477-1.107]

1.252[0.916-1.679]

Enrichment in subset A

77

334

–

Final analysis

Millen

1.156[0.890-1.477]

0.858[0.350-1.688]

1.252[0.916-1.677]

Enrichment in subset A

102

334

–

 

Gail and Simon

1.156[0.890-1.477]

0.858[0.350-1.688]

1.252[0.916-1.677]

Enrichment in subset A

102

334

–

PaO2/FiO2Partition

PaO2/FiO2<100

PaO2/FiO2≥100

    

1er interim analysis

Millen

 

1.380[0.852-2.131]

0.848[0.498-1.342]

Go with entire population

80

114

0.78

 

Gail and Simon

 

1.380[0.852-2.131]

0.848[0.498-1.342]

Go with entire population

80

114

0.07& 0.28

2nd interim analysis

Millen

 

1.164[0.790-1.659]

1.050[0.717-1.475]

Go with entire population

152

236

0.30

 

Gail and Simon

 

1.164[0.790-1.659]

1.050[0.717-1.475]

Go with entire population

152

236

0.00& 0.03

3th interim analysis

Millen

 

0.973[0.694-1.319]

0.957[0.711-1.254]

Go with entire population

219

366

0.16

 

Gail and Simon

 

0.973[0.694-1.319]

0.957[0.711-1.254]

Go with entire population

219

366

0.00& 0.00

Final analysis

Millen

0.998[0.824-1.196]

0.983[0.731-1.292]

1.017[0.809-1.263]

Go with entire population

278

498

0.09

 

Gail and Simon

0.998[0.824-1.196]

0.983[0.731-1.292]

1.017[0.809-1.263]

Go with entire population

278

498

0.00& 0.00

  1. The reported intervals are 95% credibility intervals, defined as [quantile(2.5%), quantile(97.5%)] of the posterior distribution.
  2. * In case of Millen’s criterion, this refers to the posterior probability that P2K (equation (2)). In case of Gail & Simon’s criterion, it refers to the posterior probabilities Pquali and Pquanti, respectively, as described in equations (5) & (6).
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BMC Medical Research Methodology

ISSN: 1471-2288

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