File size: 1,818 Bytes
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"trial_id": "HLT003-CARD-CONT-001",
"trial_name": "Phase III RCT \u2014 LDL-C Reduction with Lipid-Lowering Therapy",
"sponsor": "XpertSystems Pharma LLC",
"n_participants": 800,
"trial_phase": "III",
"blinding": "DOUBLE",
"randomization": "STRATIFIED",
"n_sites": 30,
"arms": [
{
"arm_id": 0,
"label": "Placebo",
"randomization_weight": 1,
"treatment_effect_cohens_d": 0.0,
"ae_multiplier": 1.0
},
{
"arm_id": 1,
"label": "Drug A 50mg",
"randomization_weight": 1,
"treatment_effect_cohens_d": 0.4,
"ae_multiplier": 1.6
},
{
"arm_id": 2,
"label": "Drug A 100mg",
"randomization_weight": 1,
"treatment_effect_cohens_d": 0.75,
"ae_multiplier": 2.2
}
],
"therapeutic_area": "Cardiology",
"endpoint_type": "CONTINUOUS",
"endpoint_name": "LDL-C Reduction (mg/dL)",
"endpoint_unit": "mg/dL",
"baseline_mean": 148.0,
"baseline_sd": 30.0,
"placebo_change_mean": -8.0,
"residual_sd_factor": 0.35,
"visit_schedule": [
-2,
0,
1,
2,
4,
8,
12,
16,
20,
24,
28
],
"dropout_mcar_rate": 0.04,
"dropout_mar_baseline_logit": -3.5,
"dropout_mar_severity_coef": 0.025,
"dropout_mar_age_coef": 0.015,
"dropout_mar_arm_coef": 0.4,
"dropout_mnar_fraction": 0.15,
"ae_base_rate_per_patient": 3.2,
"ae_active_arm_increment": 1.5,
"ae_grade_probs_placebo": [
0.45,
0.32,
0.16,
0.05,
0.02
],
"ae_grade_probs_active": [
0.38,
0.3,
0.2,
0.08,
0.04
],
"subgroups": {
"biomarker_positive_fraction": 0.42,
"biomarker_treatment_interaction": 0.2,
"elderly_fraction": 0.28,
"elderly_ae_multiplier": 1.3
},
"output_filename": "cardiology_ldl_trial.csv",
"seed": 42
} |