{
  "schema_version": "2.0",
  "artifact_kind": "clinical_trial_safety_aggregate_draft",
  "draft_status": "BLOCKED_INCOMPLETE_NOT_AN_INDIVIDUAL_CASE_SAFETY_REPORT",
  "safety_notice": "Aggregate display only. Do not use for individual-case assessment, reportability, transmission, causality, expectedness, seriousness, filing, or submission.",
  "data_classification": "aggregate",
  "authorized_purpose": null,
  "authorization_verified": false,
  "local_only_handling_confirmed": false,
  "analysis_metadata": {
    "protocol_reference": null,
    "sap_reference": null,
    "data_cut_reference": null,
    "analysis_set": null,
    "counting_rule": null,
    "threshold_rule": null,
    "meddra_version": null,
    "meddra_language": null,
    "coding_source_reference": null
  },
  "input_csv": "adverse_event_aggregate_input_template.csv",
  "required_columns": [
    "analysis_set",
    "treatment_group",
    "meddra_version",
    "system_organ_class",
    "preferred_term",
    "subjects_affected",
    "event_count",
    "denominator"
  ],
  "prohibited_content": [
    "patient identifiers",
    "subject identifiers",
    "case identifiers",
    "verbatim terms",
    "narratives",
    "exact event dates",
    "contact information"
  ],
  "provenance_manifest": null,
  "review": {
    "safety_coding_review": "pending",
    "statistical_review": "pending",
    "privacy_review": "pending",
    "regulatory_review": "pending",
    "submission_authorized": false
  }
}