{
  "topic": {
    "stem": "SUTIMLIMAB_CAD_REVIEW",
    "name": "Sutimlimab in cold agglutinin disease",
    "ncts": [
      "NCT03347396",
      "NCT03347422"
    ],
    "drug_patterns": [
      "sutimlimab"
    ],
    "condition_patterns": [
      "agglutinin"
    ]
  },
  "trials": [
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": false,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03347396",
        "aact_title": "A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)",
        "aact_acronym": "",
        "start_date": "2018-03-05",
        "primary_completion_date": "2021-10-05",
        "aact_intvs": [
          "BIVV009"
        ],
        "aact_conditions": [
          "agglutinin disease, cold"
        ],
        "pmid": "37459203",
        "pubmed_year": 2023,
        "pubmed_doi": "10.1182/bloodadvances.2022009318",
        "aact_per_arm_counts": {
          "BG000": 17,
          "BG001": 7
        },
        "aact_primary_outcome_measure": "Part A: Percentage of Participants With Response to Treatment",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "16.0"
          ],
          [
            "OG000",
            "8.0"
          ],
          [
            "OG000",
            "3.0"
          ],
          [
            "OG000",
            "0.0"
          ],
          [
            "OG000",
            "54.2"
          ],
          [
            "OG000",
            "16.0"
          ],
          [
            "OG001",
            "6.0"
          ],
          [
            "OG000",
            "10.0"
          ],
          [
            "OG001",
            "2.0"
          ],
          [
            "OG000",
            "5.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03347422",
        "aact_title": "A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion",
        "aact_acronym": "Cadenza",
        "start_date": "2018-03-17",
        "primary_completion_date": "2021-12-03",
        "aact_intvs": [
          "sutimlimab (BIVV009)",
          "placebo"
        ],
        "aact_conditions": [
          "cold agglutinin disease"
        ],
        "pmid": "36403132",
        "pubmed_year": 2023,
        "pubmed_doi": "10.1111/ejh.13903",
        "aact_per_arm_counts": {
          "BG000": 22,
          "BG001": 20
        },
        "aact_primary_outcome_measure": "Part A: Percentage of Participants With Response to Treatment",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "7.0"
          ],
          [
            "OG001",
            "5.0"
          ],
          [
            "OG000",
            "1.0"
          ],
          [
            "OG001",
            "0.0"
          ],
          [
            "OG000",
            "0.0"
          ],
          [
            "OG001",
            "0.0"
          ],
          [
            "OG000",
            "5.0"
          ],
          [
            "OG001",
            "4.0"
          ],
          [
            "OG000",
            "8.0"
          ],
          [
            "OG001",
            "7.0"
          ]
        ]
      }
    }
  ],
  "gate_summary": {
    "A_aact_exists": 2,
    "C_condition_in_aact": 2,
    "D_pmid_topic_match": 2,
    "E_two_arms": 2,
    "F_primary_outcome_known": 2,
    "B_drug_in_intvs": 1
  },
  "n_total": 2,
  "n_pass_all": 1,
  "pass_rate": 0.5,
  "verdict": "VIABLE"
}