{
  "schema_version": 1,
  "evaluated_at": "2026-09-12T20:27:51.150Z",
  "matcher_version": 9,
  "assessment": "Targeted formulation challenge against frozen provisional AI source labels",
  "labels_sha256": "5d354dca54f0912f6e51c3f850dd7c7bab880b58e2956741e93d47d16f8800b6",
  "products_sha256": "acb6715d342a653907545b76602b39c93190511dabc844ef3e2fda9315f528d1",
  "independent_human_reviews": 0,
  "counts": {
    "pairs": 8,
    "supported_and_surfaced": 3,
    "supported_but_not_surfaced": 2,
    "unsupported_but_surfaced": 0,
    "unsupported_and_withheld": 3
  },
  "limitations": [
    "Targeted eight-pair engineering set, not a random or independent holdout sample.",
    "Labels are AI assessments requiring independent human review.",
    "Does not measure database-wide accuracy, search recall, efficacy or exact Canadian product exposure.",
    "Preserve baseline results if later code changes are informed by these cases."
  ],
  "cases": [
    {
      "case_id": "FORM-01",
      "din": "02258595",
      "study_id": "NCT00963313",
      "source_url": "https://clinicaltrials.gov/study/NCT00963313",
      "source_sha256": "9d4d550caa0a17a34eb982674f742b6bdc777272f996d68039a8e60d0145dffa",
      "expected_formulation_match": true,
      "actual_formulation_match": false,
      "actual_tier": "individual_ingredient",
      "reason": "individual_ingredient",
      "formulation_assessment": {
        "status": "not_established",
        "reason_code": "observational_cohort_scope",
        "short_reason": "Ingredient reported in an observational cohort; formulation not verified",
        "reasons": [
          "The registry documents a named cohort and its linked medication. Observational use does not establish assigned treatment, receipt by every participant or the complete selected Canadian formulation."
        ],
        "diagnostics": [
          {
            "arm": "Adalimumab, injection",
            "intervention": "Adalimumab (HUMIRA®)",
            "source_field": "protocolSection.armsInterventionsModule.interventions[0]",
            "code": "observational_cohort_scope",
            "source_limit": true,
            "components": [
              "adalimumab"
            ]
          }
        ]
      },
      "agreement": false
    },
    {
      "case_id": "FORM-02",
      "din": "02378604",
      "study_id": "NCT03630055",
      "source_url": "https://clinicaltrials.gov/study/NCT03630055",
      "source_sha256": "b6297c50398fdd6ecb7e74472dc62166e503c6b11b2ab968a57c876e36870038",
      "expected_formulation_match": true,
      "actual_formulation_match": true,
      "actual_tier": "same_combination",
      "reason": "explicit_local_formulation",
      "formulation_assessment": null,
      "agreement": true
    },
    {
      "case_id": "FORM-03",
      "din": "02378612",
      "study_id": "NCT05128591",
      "source_url": "https://clinicaltrials.gov/study/NCT05128591",
      "source_sha256": "a418e4fa2ca129461449072547835681c165c5be5e86c5b702b8afe45cd1544d",
      "expected_formulation_match": true,
      "actual_formulation_match": true,
      "actual_tier": "same_combination",
      "reason": "explicit_local_formulation",
      "formulation_assessment": null,
      "agreement": true
    },
    {
      "case_id": "FORM-04",
      "din": "02274906",
      "study_id": "NCT00448669",
      "source_url": "https://clinicaltrials.gov/study/NCT00448669",
      "source_sha256": "d7cf492c994fb59a271cd8efc8857e1e30089be7f986ccde5205c748d38271c9",
      "expected_formulation_match": true,
      "actual_formulation_match": true,
      "actual_tier": "same_combination",
      "reason": "explicit_local_formulation",
      "formulation_assessment": null,
      "agreement": true
    },
    {
      "case_id": "FORM-05",
      "din": "02274906",
      "study_id": "NCT00458393",
      "source_url": "https://clinicaltrials.gov/study/NCT00458393",
      "source_sha256": "8bebb089d24905dfee9bcb72db4f7f7e733937463eabcbb233911e733aa2aad3",
      "expected_formulation_match": true,
      "actual_formulation_match": false,
      "actual_tier": "unresolved",
      "reason": "per_unit_composition_unverified",
      "formulation_assessment": null,
      "agreement": false
    },
    {
      "case_id": "FORM-06",
      "din": "02316986",
      "study_id": "NCT03630055",
      "source_url": "https://clinicaltrials.gov/study/NCT03630055",
      "source_sha256": "b6297c50398fdd6ecb7e74472dc62166e503c6b11b2ab968a57c876e36870038",
      "expected_formulation_match": false,
      "actual_formulation_match": false,
      "actual_tier": "individual_ingredient",
      "reason": "individual_ingredient",
      "formulation_assessment": {
        "status": "not_established",
        "reason_code": "reported_strength_differs",
        "short_reason": "Reported ingredient strength differs from this product",
        "reasons": [
          "A parsed ingredient quantity differs from the selected formulation; unit normalization preserves dose basis."
        ],
        "diagnostics": [
          {
            "arm": "Rivaroxaban",
            "intervention": "Rivaroxaban 15 MG Oral Tablet [Xarelto]",
            "source_field": "protocolSection.armsInterventionsModule.interventions[0]",
            "code": "reported_strength_differs",
            "source_limit": true,
            "components": [
              "rivaroxaban"
            ]
          }
        ]
      },
      "agreement": true
    },
    {
      "case_id": "FORM-07",
      "din": "02303922",
      "study_id": "NCT02202161",
      "source_url": "https://clinicaltrials.gov/study/NCT02202161",
      "source_sha256": "475a89114cf54243af5c12a005aba7a6879185a69659c15857f2d408afe1d935",
      "expected_formulation_match": false,
      "actual_formulation_match": false,
      "actual_tier": "individual_ingredient",
      "reason": "individual_ingredient",
      "formulation_assessment": {
        "status": "not_established",
        "reason_code": "additional_composition_unverified",
        "short_reason": "Additional composition requires source review",
        "reasons": [
          "The intervention has additional active-composition assertions that cannot be reconciled with the complete selected formulation."
        ],
        "diagnostics": [
          {
            "arm": "GSK2330672 10 mg",
            "intervention": "GSK2330672",
            "source_field": "protocolSection.armsInterventionsModule.interventions[0]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "GSK2330672 10 mg",
            "intervention": "Metformin",
            "source_field": "protocolSection.armsInterventionsModule.interventions[3]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "GSK2330672 20 mg",
            "intervention": "GSK2330672",
            "source_field": "protocolSection.armsInterventionsModule.interventions[0]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "GSK2330672 20 mg",
            "intervention": "Metformin",
            "source_field": "protocolSection.armsInterventionsModule.interventions[3]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "GSK2330672 30 mg",
            "intervention": "GSK2330672",
            "source_field": "protocolSection.armsInterventionsModule.interventions[0]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "GSK2330672 30 mg",
            "intervention": "Metformin",
            "source_field": "protocolSection.armsInterventionsModule.interventions[3]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "GSK2330672 90 mg",
            "intervention": "GSK2330672",
            "source_field": "protocolSection.armsInterventionsModule.interventions[0]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "GSK2330672 90 mg",
            "intervention": "Metformin",
            "source_field": "protocolSection.armsInterventionsModule.interventions[3]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "Sitagliptin 50 mg",
            "intervention": "Sitagliptin",
            "source_field": "protocolSection.armsInterventionsModule.interventions[2]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": [
              "sitagliptin (sitagliptin phosphate monohydrate)"
            ]
          },
          {
            "arm": "Sitagliptin 50 mg",
            "intervention": "Metformin",
            "source_field": "protocolSection.armsInterventionsModule.interventions[3]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          }
        ]
      },
      "agreement": true
    },
    {
      "case_id": "FORM-08",
      "din": "02274906",
      "study_id": "NCT03675815",
      "source_url": "https://clinicaltrials.gov/study/NCT03675815",
      "source_sha256": "1c7fb6b040b897b2d72dcfda6eb3453e5c7fe737c968778acce6ab62209a9cf6",
      "expected_formulation_match": false,
      "actual_formulation_match": false,
      "actual_tier": "individual_ingredient",
      "reason": "individual_ingredient",
      "formulation_assessment": {
        "status": "not_established",
        "reason_code": "additional_composition_unverified",
        "short_reason": "Additional composition requires source review",
        "reasons": [
          "The intervention has additional active-composition assertions that cannot be reconciled with the complete selected formulation."
        ],
        "diagnostics": [
          {
            "arm": "Standard of care",
            "intervention": "Darunavir (DRV) 800 milligram (MG) Oral Tablet",
            "source_field": "protocolSection.armsInterventionsModule.interventions[0]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "Standard of care",
            "intervention": "Ritonavir 100 MG Oral Tablet",
            "source_field": "protocolSection.armsInterventionsModule.interventions[1]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "Standard of care",
            "intervention": "N(t)RTIs",
            "source_field": "protocolSection.armsInterventionsModule.interventions[2]",
            "code": "dosage_form_unverified",
            "source_limit": true,
            "components": []
          },
          {
            "arm": "Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC)",
            "intervention": "Dolutegravir 50 MG Oral Tablet",
            "source_field": "protocolSection.armsInterventionsModule.interventions[3]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC)",
            "intervention": "TDF 300 MG Oral Tablet",
            "source_field": "protocolSection.armsInterventionsModule.interventions[4]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC)",
            "intervention": "3TC 300 MG Oral Tablet",
            "source_field": "protocolSection.armsInterventionsModule.interventions[5]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": [
              "emtricitabine"
            ]
          },
          {
            "arm": "Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC)",
            "intervention": "FTC 200 MG Oral Cap",
            "source_field": "protocolSection.armsInterventionsModule.interventions[6]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": [
              "emtricitabine"
            ]
          },
          {
            "arm": "Dolutegravir + darunavir",
            "intervention": "Darunavir (DRV) 800 milligram (MG) Oral Tablet",
            "source_field": "protocolSection.armsInterventionsModule.interventions[0]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "Dolutegravir + darunavir",
            "intervention": "Ritonavir 100 MG Oral Tablet",
            "source_field": "protocolSection.armsInterventionsModule.interventions[1]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          },
          {
            "arm": "Dolutegravir + darunavir",
            "intervention": "Dolutegravir 50 MG Oral Tablet",
            "source_field": "protocolSection.armsInterventionsModule.interventions[3]",
            "code": "additional_composition_unverified",
            "source_limit": false,
            "components": []
          }
        ]
      },
      "agreement": true
    }
  ]
}