File size: 1,674 Bytes
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"trial_id": "HLT003-ONC-TTE-001",
"trial_name": "Phase II RCT \u2014 Oncology Progression-Free Survival",
"sponsor": "XpertSystems Pharma LLC",
"n_participants": 600,
"trial_phase": "II",
"blinding": "OPEN",
"randomization": "STRATIFIED",
"n_sites": 20,
"arms": [
{
"arm_id": 0,
"label": "SoC Chemotherapy",
"randomization_weight": 1,
"treatment_effect_cohens_d": 0.0,
"ae_multiplier": 1.0
},
{
"arm_id": 1,
"label": "Targeted Therapy",
"randomization_weight": 1,
"treatment_effect_cohens_d": 0.3,
"ae_multiplier": 1.3
}
],
"therapeutic_area": "Oncology",
"endpoint_type": "TTE",
"endpoint_name": "Progression-Free Survival",
"endpoint_unit": "weeks",
"tte_median_placebo_weeks": 14.0,
"tte_hazard_ratios": [
1.0,
0.6
],
"tte_censoring_rate": 0.35,
"treatment_weeks": 52,
"visit_schedule": [
-2,
0,
4,
8,
12,
16,
20,
24,
32,
40,
52
],
"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": 4.5,
"ae_active_arm_increment": 1.5,
"ae_grade_probs_placebo": [
0.3,
0.3,
0.25,
0.1,
0.05
],
"ae_grade_probs_active": [
0.25,
0.28,
0.27,
0.12,
0.08
],
"subgroups": {
"biomarker_positive_fraction": 0.35,
"biomarker_treatment_interaction": 0.25,
"elderly_fraction": 0.45,
"elderly_ae_multiplier": 1.4
},
"output_filename": "oncology_pfs_trial.csv",
"seed": 42
} |