{
  "schema_version": 1,
  "evaluated_at": "2026-09-11T03:42:13.646Z",
  "matcher_version": 8,
  "assessment": "Agreement with separately prepared AI source labels; independent human review pending",
  "independent_human_approvals": 0,
  "labels_sha256": "7ae24a29a214a933be6dc12812b22b87d05cda9f2dc3e6c3b56255b9ad104cf3",
  "products_sha256": "498d7073f308f36058b06a75c9231eac5163c6d95d3321a937d11f68cadd0c16",
  "selection_sha256": "11eee0ea829d61861f4d2c0fe169be27d124e175aaab72fad1ef92b15d2d1757",
  "sample": {
    "pairs": 16,
    "unique_studies": 12,
    "products": 4,
    "retrieved_pairs": 12,
    "constructed_mismatch_controls": 4
  },
  "qualified_ingredient_label_agreement": {
    "supported_and_surfaced": 6,
    "unsupported_but_surfaced": 0,
    "supported_but_not_surfaced": 0,
    "not_qualified_and_withheld": 10,
    "precision_against_provisional_labels": 1,
    "recall_against_provisional_labels": 1
  },
  "coverage": {
    "source_relevant_pairs": 12,
    "source_relevant_pairs_with_qualified_link": 6,
    "withheld_pairs": 10,
    "formulation_promotions": 0,
    "exact_product_promotions": 0
  },
  "limitations": [
    "Small purposive sample with four constructed negative controls; not a population accuracy estimate.",
    "Labels were prepared by another AI agent, not an independent human or clinical expert. Shared AI limitations may affect labels and code.",
    "Accessible prior NCT IDs were excluded; independence from all historical work is not established.",
    "No complete-formulation positive cases: formulation sensitivity and exact-product accuracy cannot be measured.",
    "This measures classification of supplied records, not search recall across all studies.",
    "Selection and labels were frozen before this matcher run; no rules were tuned using these cases."
  ],
  "cases": [
    {
      "case_id": "EVAL-01",
      "drug_code": "74379",
      "din": "02258595",
      "study_id": "NCT00235859",
      "case_kind": "retrieved_candidate",
      "source_url": "https://clinicaltrials.gov/study/NCT00235859",
      "source_fixture_sha256": "5bddb0c743083a56a73b1f037301702b8fc9369cda374ec9daf9dda738b2cfb4",
      "expected_qualified_ingredient_link": false,
      "expected_document_relevance": "supported",
      "actual_tier": "unresolved",
      "actual_reason": "no_reported_arms",
      "qualified_label_agreement": true,
      "source_assessment": "The registry lists adalimumab as a drug and the summary names it as study treatment; no structured arm groups or reciprocal links are supplied.",
      "remaining_formulation_gap": "The record does not report the selected 40 mg/0.8 mL solution and subcutaneous presentation."
    },
    {
      "case_id": "EVAL-02",
      "drug_code": "74379",
      "din": "02258595",
      "study_id": "NCT00291915",
      "case_kind": "retrieved_candidate",
      "source_url": "https://clinicaltrials.gov/study/NCT00291915",
      "source_fixture_sha256": "08840f42856fda1d445e6b5496d1fb8cc01d6c6052497e77190086b5e16c65c4",
      "expected_qualified_ingredient_link": false,
      "expected_document_relevance": "supported",
      "actual_tier": "unresolved",
      "actual_reason": "description_arm_needs_review",
      "qualified_label_agreement": true,
      "source_assessment": "The detailed description explicitly places adalimumab in the methotrexate combination treatment; structured arm groups and reciprocal links are absent.",
      "remaining_formulation_gap": "The 40 mg schedule is an administered dose, not proof of the 40 mg/0.8 mL unit, solution form and route."
    },
    {
      "case_id": "EVAL-03",
      "drug_code": "74379",
      "din": "02258595",
      "study_id": "NCT00645905",
      "case_kind": "retrieved_candidate",
      "source_url": "https://clinicaltrials.gov/study/NCT00645905",
      "source_fixture_sha256": "55697185b513f8b43aafaa2b3c54a0c5fec7459bd304ae945051802cf5490e4e",
      "expected_qualified_ingredient_link": true,
      "expected_document_relevance": "supported",
      "actual_tier": "individual_ingredient",
      "actual_reason": "individual_ingredient",
      "qualified_label_agreement": true,
      "source_assessment": "The adalimumab intervention is reciprocally linked to active-comparator arm A; the separate placebo-for-adalimumab intervention is not ingredient exposure evidence.",
      "remaining_formulation_gap": "The dosing schedule omits a 40 mg/0.8 mL unit, solution form and subcutaneous route. The active comparator relationship does not establish efficacy."
    },
    {
      "case_id": "EVAL-04",
      "drug_code": "80247",
      "din": "02316986",
      "study_id": "NCT00559988",
      "case_kind": "retrieved_candidate",
      "source_url": "https://clinicaltrials.gov/study/NCT00559988",
      "source_fixture_sha256": "f1100f575a79b6313e5c10600fccd4beef283169f8c2856829a0e6b434a3d4fb",
      "expected_qualified_ingredient_link": false,
      "expected_document_relevance": "supported",
      "actual_tier": "unresolved",
      "actual_reason": "dosage_form_unverified",
      "qualified_label_agreement": true,
      "source_assessment": "Both linked strategy interventions list rivaroxaban among several anticoagulant options. This supports relevance, not assignment of rivaroxaban to every participant or a separable rivaroxaban-only arm.",
      "remaining_formulation_gap": "No rivaroxaban 10 mg tablet unit or separable selected-product intervention is established; the treatment strategy permits multiple alternatives."
    },
    {
      "case_id": "EVAL-05",
      "drug_code": "80247",
      "din": "02316986",
      "study_id": "NCT00839826",
      "case_kind": "retrieved_candidate",
      "source_url": "https://clinicaltrials.gov/study/NCT00839826",
      "source_fixture_sha256": "0be1e563677c81c9d833b2fe5888b24b60e2f39ec6b54e0a3bc768bd89bda82c",
      "expected_qualified_ingredient_link": true,
      "expected_document_relevance": "supported",
      "actual_tier": "individual_ingredient",
      "actual_reason": "individual_ingredient",
      "qualified_label_agreement": true,
      "source_assessment": "The rivaroxaban drug is reciprocally linked to experimental arm 1; enoxaparin is the separate active comparator.",
      "remaining_formulation_gap": "Multiple dose regimens are listed, without a specified 10 mg tablet unit and oral route for the selected Canadian presentation."
    },
    {
      "case_id": "EVAL-06",
      "drug_code": "80247",
      "din": "02316986",
      "study_id": "NCT01145859",
      "case_kind": "retrieved_candidate",
      "source_url": "https://clinicaltrials.gov/study/NCT01145859",
      "source_fixture_sha256": "34602cb4703bbb6c098d08dc7f555663a0500cb1145c6261cc8257d458022183",
      "expected_qualified_ingredient_link": true,
      "expected_document_relevance": "supported",
      "actual_tier": "individual_ingredient",
      "actual_reason": "individual_ingredient",
      "qualified_label_agreement": true,
      "source_assessment": "The rivaroxaban drug is reciprocally linked to experimental arm 1. Adult dose-equivalent exposure does not identify the administered pediatric product strength.",
      "remaining_formulation_gap": "The record reports weight-adjusted exposure equivalence, not a 10 mg tablet unit, form and route."
    },
    {
      "case_id": "EVAL-07",
      "drug_code": "78924",
      "din": "02303922",
      "study_id": "NCT00660075",
      "case_kind": "retrieved_candidate",
      "source_url": "https://clinicaltrials.gov/study/NCT00660075",
      "source_fixture_sha256": "640d0e377c42f0cc6f0e1d8b858f7fb8acedfcc9cf4cd141184d98fadabe202d",
      "expected_qualified_ingredient_link": true,
      "expected_document_relevance": "supported",
      "actual_tier": "individual_ingredient",
      "actual_reason": "individual_ingredient",
      "qualified_label_agreement": true,
      "source_assessment": "Sitagliptin is reciprocally linked to experimental arm 1 and distinguished from placebo arm 2. The medicinal moiety is named; phosphate-monohydrate identity is not established.",
      "remaining_formulation_gap": "The record gives 100 mg/day, not a 100 mg-per-tablet unit; tablet, oral route and the stated salt/hydrate are not all supplied."
    },
    {
      "case_id": "EVAL-08",
      "drug_code": "78924",
      "din": "02303922",
      "study_id": "NCT00686634",
      "case_kind": "retrieved_candidate",
      "source_url": "https://clinicaltrials.gov/study/NCT00686634",
      "source_fixture_sha256": "50af3fee49efd59f5fca014dd524b06c15fed70de607cdb38497adc56ebc0a9e",
      "expected_qualified_ingredient_link": true,
      "expected_document_relevance": "supported",
      "actual_tier": "individual_ingredient",
      "actual_reason": "individual_ingredient",
      "qualified_label_agreement": true,
      "source_assessment": "The sitagliptin drug is reciprocally linked to experimental arm 1, with a Januvia trade-name alias. The source explicitly states oral administration.",
      "remaining_formulation_gap": "A 100 mg administered daily dose and brand alias do not establish a 100 mg-per-tablet unit and salt/hydrate presentation."
    },
    {
      "case_id": "EVAL-09",
      "drug_code": "78924",
      "din": "02303922",
      "study_id": "NCT00700817",
      "case_kind": "retrieved_candidate",
      "source_url": "https://clinicaltrials.gov/study/NCT00700817",
      "source_fixture_sha256": "9033ac4280e89db6a36ea2b95811e6bdd5d7f5f9e50372ae501249693cf24b00",
      "expected_qualified_ingredient_link": true,
      "expected_document_relevance": "supported",
      "actual_tier": "individual_ingredient",
      "actual_reason": "individual_ingredient",
      "qualified_label_agreement": true,
      "source_assessment": "Sitagliptin is reciprocally linked to the Sita comparator and sequential crossover arms; metformin is a separate co-treatment. The later switch to liraglutide must not be described as concurrent fixed combination.",
      "remaining_formulation_gap": "The 100 mg daily tablet regimen does not explicitly establish a per-tablet quantity and route; salt/hydrate identity is unreported."
    },
    {
      "case_id": "EVAL-10",
      "drug_code": "69428",
      "din": "02245385",
      "study_id": "NCT00235911",
      "case_kind": "retrieved_candidate",
      "source_url": "https://clinicaltrials.gov/study/NCT00235911",
      "source_fixture_sha256": "ffaa2b8c711085e58d60cf0fd505b66a505cb679b56ea2e2dbf4254c23c8b4ae",
      "expected_qualified_ingredient_link": false,
      "expected_document_relevance": "supported",
      "actual_tier": "unresolved",
      "actual_reason": "no_reported_arms",
      "qualified_label_agreement": true,
      "source_assessment": "The named drug supplies direct budesonide ingredient relevance and reports formoterol; structured arm groups are absent. Formoterol fumarate dihydrate is not explicitly identified.",
      "remaining_formulation_gap": "No 100/6 mcg-per-actuation quantities or explicit powder presentation establish the selected DIN formulation; no salt/hydrate equivalence is inferred."
    },
    {
      "case_id": "EVAL-11",
      "drug_code": "69428",
      "din": "02245385",
      "study_id": "NCT00238784",
      "case_kind": "retrieved_candidate",
      "source_url": "https://clinicaltrials.gov/study/NCT00238784",
      "source_fixture_sha256": "d306ca3c33440476b75658e7d405c916f90846575da71baa24a0c5e34e158634",
      "expected_qualified_ingredient_link": false,
      "expected_document_relevance": "supported",
      "actual_tier": "unresolved",
      "actual_reason": "no_reported_arms",
      "qualified_label_agreement": true,
      "source_assessment": "The named drug supplies direct budesonide ingredient relevance and reports formoterol; structured arm groups are absent. Formoterol fumarate dihydrate is not explicitly identified.",
      "remaining_formulation_gap": "No 100/6 mcg-per-actuation quantities or explicit powder presentation establish the selected DIN formulation; no salt/hydrate equivalence is inferred."
    },
    {
      "case_id": "EVAL-12",
      "drug_code": "69428",
      "din": "02245385",
      "study_id": "NCT00379028",
      "case_kind": "retrieved_candidate",
      "source_url": "https://clinicaltrials.gov/study/NCT00379028",
      "source_fixture_sha256": "4a62e683efbee416bd8d0a5cfddb02327a486e7d10ded9b0609d9c94f5245d88",
      "expected_qualified_ingredient_link": false,
      "expected_document_relevance": "supported",
      "actual_tier": "unresolved",
      "actual_reason": "no_reported_arms",
      "qualified_label_agreement": true,
      "source_assessment": "The source lists budesonide/formoterol and salmeterol/fluticasone as distinct drug interventions. Arm groups are absent; the separate products must not be merged into one formulation.",
      "remaining_formulation_gap": "No 100/6 mcg-per-actuation quantities, explicit powder presentation or formoterol fumarate dihydrate identity establish the selected DIN formulation."
    },
    {
      "case_id": "EVAL-13",
      "drug_code": "74379",
      "din": "02258595",
      "study_id": "NCT00559988",
      "case_kind": "constructed_mismatch_control",
      "source_url": "https://clinicaltrials.gov/study/NCT00559988",
      "source_fixture_sha256": "f1100f575a79b6313e5c10600fccd4beef283169f8c2856829a0e6b434a3d4fb",
      "expected_qualified_ingredient_link": false,
      "expected_document_relevance": "not_found_in_record",
      "actual_tier": "unresolved",
      "actual_reason": "dosage_form_unverified",
      "qualified_label_agreement": true,
      "source_assessment": "The selected product ingredient/name is not present in this deliberately cross-paired source record. The registry drug interventions concern the other selected product. This is a source-local mismatch, not proof no relationship exists anywhere.",
      "remaining_formulation_gap": "No selected-product ingredient relationship or formulation evidence in the supplied source."
    },
    {
      "case_id": "EVAL-14",
      "drug_code": "80247",
      "din": "02316986",
      "study_id": "NCT00660075",
      "case_kind": "constructed_mismatch_control",
      "source_url": "https://clinicaltrials.gov/study/NCT00660075",
      "source_fixture_sha256": "640d0e377c42f0cc6f0e1d8b858f7fb8acedfcc9cf4cd141184d98fadabe202d",
      "expected_qualified_ingredient_link": false,
      "expected_document_relevance": "not_found_in_record",
      "actual_tier": "unresolved",
      "actual_reason": "additional_composition_unverified",
      "qualified_label_agreement": true,
      "source_assessment": "The selected product ingredient/name is not present in this deliberately cross-paired source record. The registry drug interventions concern the other selected product. This is a source-local mismatch, not proof no relationship exists anywhere.",
      "remaining_formulation_gap": "No selected-product ingredient relationship or formulation evidence in the supplied source."
    },
    {
      "case_id": "EVAL-15",
      "drug_code": "78924",
      "din": "02303922",
      "study_id": "NCT00235911",
      "case_kind": "constructed_mismatch_control",
      "source_url": "https://clinicaltrials.gov/study/NCT00235911",
      "source_fixture_sha256": "ffaa2b8c711085e58d60cf0fd505b66a505cb679b56ea2e2dbf4254c23c8b4ae",
      "expected_qualified_ingredient_link": false,
      "expected_document_relevance": "not_found_in_record",
      "actual_tier": "unresolved",
      "actual_reason": "no_reported_arms",
      "qualified_label_agreement": true,
      "source_assessment": "The selected product ingredient/name is not present in this deliberately cross-paired source record. The registry drug interventions concern the other selected product. This is a source-local mismatch, not proof no relationship exists anywhere.",
      "remaining_formulation_gap": "No selected-product ingredient relationship or formulation evidence in the supplied source."
    },
    {
      "case_id": "EVAL-16",
      "drug_code": "69428",
      "din": "02245385",
      "study_id": "NCT00235859",
      "case_kind": "constructed_mismatch_control",
      "source_url": "https://clinicaltrials.gov/study/NCT00235859",
      "source_fixture_sha256": "5bddb0c743083a56a73b1f037301702b8fc9369cda374ec9daf9dda738b2cfb4",
      "expected_qualified_ingredient_link": false,
      "expected_document_relevance": "not_found_in_record",
      "actual_tier": "unresolved",
      "actual_reason": "no_reported_arms",
      "qualified_label_agreement": true,
      "source_assessment": "The selected product ingredient/name is not present in this deliberately cross-paired source record. The registry drug interventions concern the other selected product. This is a source-local mismatch, not proof no relationship exists anywhere.",
      "remaining_formulation_gap": "No selected-product ingredient relationship or formulation evidence in the supplied source."
    }
  ]
}