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"trial_id": {
"type": "string",
"description": "Unique trial identifier string"
},
"n_participants": {
"type": "integer",
"description": "Total randomized participants (100\u201350000)",
"range": [
100,
50000
]
},
"trial_phase": {
"type": "string",
"description": "I | II | III | IV"
},
"blinding": {
"type": "string",
"description": "OPEN | SINGLE | DOUBLE"
},
"randomization": {
"type": "string",
"description": "SIMPLE | BLOCK | STRATIFIED | MINIMIZATION"
},
"n_sites": {
"type": "integer",
"description": "Number of investigator sites (5\u2013200)"
},
"arms": {
"type": "array",
"description": "List of arm objects: {arm_id, label, randomization_weight, treatment_effect_cohens_d, ae_multiplier}"
},
"therapeutic_area": {
"type": "string",
"description": "Cardiology | Oncology | Neurology | Metabolic | Respiratory | Psychiatry | Rheumatology | Infectious Disease | Rare Disease | Ophthalmology | Dermatology | GI"
},
"endpoint_type": {
"type": "string",
"description": "CONTINUOUS | BINARY | TTE"
},
"endpoint_name": {
"type": "string",
"description": "Human-readable endpoint label"
},
"baseline_mean": {
"type": "float",
"description": "Mean baseline endpoint value (CONTINUOUS only)"
},
"baseline_sd": {
"type": "float",
"description": "SD of baseline endpoint (CONTINUOUS only)"
},
"placebo_change_mean": {
"type": "float",
"description": "Mean CFB for placebo arm at primary visit (CONTINUOUS only)"
},
"binary_baseline_response_rate": {
"type": "float",
"description": "Placebo response probability (BINARY only, 0\u20131)"
},
"binary_odds_ratios": {
"type": "array",
"description": "Odds ratios vs placebo per arm (BINARY only)"
},
"tte_median_placebo_weeks": {
"type": "float",
"description": "Median survival weeks in placebo (TTE only)"
},
"tte_hazard_ratios": {
"type": "array",
"description": "Hazard ratios vs placebo per arm (TTE only, <1 = benefit)"
},
"dropout_mcar_rate": {
"type": "float",
"description": "Base MCAR dropout probability per visit (0\u20130.05)"
},
"dropout_mar_arm_coef": {
"type": "float",
"description": "Logit coefficient for arm index in MAR dropout model"
},
"ae_base_rate_per_patient": {
"type": "float",
"description": "Expected AEs per placebo patient"
},
"ae_active_arm_increment": {
"type": "float",
"description": "Additional AEs per active arm step above placebo"
}
} |