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LABELS · e4a8e5b4-af77-4eca-92de-cd0982969b82

Medrol

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-11-14
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE MEDROL Tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Severe seborrheic dermatitis Exfoliative dermatitis Mycosis fungoides Pemphigus Severe psoriasis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Serum sickness Contact dermatitis Bronchial asthma Atopic dermatitis 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Keratitis Optic neuritis Allergic conjunctivitis Chorioretinitis Iritis and iridocyclitis 7. Respiratory Diseases Symptomatic sarcoidosis Berylliosis Loeffler's syndrome not manageable by other means Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Nervous System Acute exacerbations of multiple sclerosis 13. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.
Full extracted label fields
application numbers
  1. NDA011153
boxed warning exact
    brand names
    1. Medrol
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4
    generic names
    1. METHYLPREDNISOLONE
    id
    e4a8e5b4-af77-4eca-92de-cd0982969b82
    indications and usage exact
    1. INDICATIONS AND USAGE MEDROL Tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Severe seborrheic dermatitis Exfoliative dermatitis Mycosis fungoides Pemphigus Severe psoriasis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Serum sickness Contact dermatitis Bronchial asthma Atopic dermatitis 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Keratitis Optic neuritis Allergic conjunctivitis Chorioretinitis Iritis and iridocyclitis 7. Respiratory Diseases Symptomatic sarcoidosis Berylliosis Loeffler's syndrome not manageable by other means Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Nervous System Acute exacerbations of multiple sclerosis 13. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Pharmacia & Upjohn Company LLC
      matched search terms
      1. cancer
      2. lymphomas
      3. leukemia
      package ndcs
      1. 0009-0049-02
      2. 0009-0056-02
      3. 0009-0056-04
      4. 0009-0022-01
      5. 0009-0073-01
      6. 0009-0176-01
      7. 0009-0020-01
      product ndcs
      1. 0009-0020
      2. 0009-0049
      3. 0009-0056
      4. 0009-0022
      5. 0009-0073
      6. 0009-0176
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
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        2. 197971
        3. 197973
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        8. 259966
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        11. 762675
        12. 834023
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        disclaimer
        Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
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        spl effective date
        2025-11-14
        spl effective time
        20251114
        spl set id
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        spl version
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        substance names
        1. METHYLPREDNISOLONE
        uniis
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        Drugs@FDA application source records
        1. application number
          NDA011153
          payload
          all indexed label documents
          1. Appl No
            011153
            Application Docs Date
            2015-12-31 00:00:00
            Application Docs ID
            33035
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            51
            Submission Type
            SUPPL
          2. Appl No
            011153
            Application Docs Date
            2018-07-25 00:00:00
            Application Docs ID
            54965
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            75
            Submission Type
            SUPPL
          3. Appl No
            011153
            Application Docs Date
            2021-02-22 00:00:00
            Application Docs ID
            66314
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            77
            Submission Type
            SUPPL
          4. Appl No
            011153
            Application Docs Date
            2023-12-21 00:00:00
            Application Docs ID
            77098
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            81
            Submission Type
            SUPPL
          5. Appl No
            011153
            Application Docs Date
            2024-06-06 00:00:00
            Application Docs ID
            78672
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            83
            Submission Type
            SUPPL
          6. Appl No
            011153
            Application Docs Date
            2025-11-07 00:00:00
            Application Docs ID
            84122
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            82
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            011153
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            83
            Submission Status
            AP
            Submission Status Date
            2024-06-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            011153
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            82
            Submission Status
            AP
            Submission Status Date
            2025-11-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            011153
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            81
            Submission Status
            AP
            Submission Status Date
            2023-12-19 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            011153
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            77
            Submission Status
            AP
            Submission Status Date
            2019-08-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            011153
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            75
            Submission Status
            AP
            Submission Status Date
            2018-07-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            011153
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            71
            Submission Status
            AP
            Submission Status Date
            2013-07-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            011153
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            59
            Submission Status
            AP
            Submission Status Date
            2002-10-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            011153
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            58
            Submission Status
            AP
            Submission Status Date
            1999-12-01 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            011153
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            52
            Submission Status
            AP
            Submission Status Date
            1993-01-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            011153
            Review Priority
            Submission Class Code ID
            3
            Submission No
            51
            Submission Status
            AP
            Submission Status Date
            1993-12-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            011153
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            49
            Submission Status
            AP
            Submission Status Date
            1989-01-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            011153
            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
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            Submission Status
            AP
            Submission Status Date
            1987-02-24 00:00:00
            Submission Type
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            Submissions Public Notes
          application number
          NDA011153
          approval interpretation
          Application linkage and approved submission are not indication-level current approval verification
          current indication status
          not_reconciled
          has approved submission record
          true
          latest approved submission date
          2025-11-04
          latest label selection rule
          max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
          latest posted label documents
          1. Appl No
            011153
            Application Docs Date
            2025-11-07 00:00:00
            Application Docs ID
            84122
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            82
            Submission Type
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          official application record
          Appl No
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          Appl Public Notes
          Appl Type
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          Sponsor Name
          PFIZER
          openfda application present
          true
          products
          1. Active Ingredient
            METHYLPREDNISOLONE
            Appl No
            011153
            Drug Name
            MEDROL
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            4MG
            marketing status
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          2. Active Ingredient
            METHYLPREDNISOLONE
            Appl No
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            Drug Name
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            Form
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            Product No
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            Reference Drug
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            2MG
            marketing status
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          3. Active Ingredient
            METHYLPREDNISOLONE
            Appl No
            011153
            Drug Name
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            Form
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            Product No
            003
            Reference Drug
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            Reference Standard
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            Strength
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            marketing status
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          4. Active Ingredient
            METHYLPREDNISOLONE
            Appl No
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            Drug Name
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            Form
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            Product No
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            Reference Drug
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          5. Active Ingredient
            METHYLPREDNISOLONE
            Appl No
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            Drug Name
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            Form
            TABLET;ORAL
            Product No
            005
            Reference Drug
            0
            Reference Standard
            0
            Strength
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            marketing status
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          6. Active Ingredient
            METHYLPREDNISOLONE
            Appl No
            011153
            Drug Name
            MEDROL
            Form
            TABLET;ORAL
            Product No
            006
            Reference Drug
            1
            Reference Standard
            1
            Strength
            32MG
            marketing status
            1. Prescription

        Source passages and status connections

        Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

        Passage 1 · indication intro context
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        1. NDA011153
        brand names
        1. Medrol
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        INDICATIONS AND USAGE MEDROL Tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where appl
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              INDICATIONS AND USAGE MEDROL Tablets are indicated in the following conditions: 1.
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              INDICATIONS AND USAGE MEDROL Tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an
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                    Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).
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                    one or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (
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                                                                                              approval pathway
                                                                                              Source null
                                                                                              biomarker and test
                                                                                              Source null
                                                                                              disease stage
                                                                                              Source null
                                                                                              limitations
                                                                                              Source null
                                                                                              line
                                                                                              Source null
                                                                                              prior therapy
                                                                                              Source null
                                                                                              regimen
                                                                                              Source null
                                                                                              tumor histology
                                                                                              Source null
                                                                                              use intent
                                                                                              unclear
                                                                                              Passage 16 · unclassified context
                                                                                              application numbers
                                                                                              1. NDA011153
                                                                                              brand names
                                                                                              1. Medrol
                                                                                              classification reasons
                                                                                              1. no_unambiguous_positive_indication_predicate
                                                                                              clinical review status
                                                                                              pending
                                                                                              content role
                                                                                              unclassified_context
                                                                                              context span
                                                                                              end
                                                                                              3116
                                                                                              end exclusive
                                                                                              true
                                                                                              exact text
                                                                                              tem Acute exacerbations of multiple sclerosis 13. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.
                                                                                              label id
                                                                                              e4a8e5b4-af77-4eca-92de-cd0982969b82
                                                                                              offset unit
                                                                                              unicode_code_points
                                                                                              source array index
                                                                                              0
                                                                                              source field
                                                                                              indications_and_usage_exact
                                                                                              source text sha256
                                                                                              c573dae6001e76b69e5f220c6c63d773da35dc743c564c184e94a81a114c336e
                                                                                              start
                                                                                              2862
                                                                                              current approval status
                                                                                              not_reconciled
                                                                                              duplicate text group
                                                                                              dup-b25a328856c26bc28e02
                                                                                              extraction review status
                                                                                              automated_candidate_pending_source_review
                                                                                              generic names
                                                                                              1. METHYLPREDNISOLONE
                                                                                              id
                                                                                              ind-span-1917f54c7484df229d9a
                                                                                              label id
                                                                                              e4a8e5b4-af77-4eca-92de-cd0982969b82
                                                                                              positive predicate support span
                                                                                              Source null
                                                                                              qualifier mentions
                                                                                                regulatory links
                                                                                                  schema version
                                                                                                  0.1.0
                                                                                                  source batch sha256
                                                                                                  24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                                                                                                  source defined aliases
                                                                                                    source span
                                                                                                    end
                                                                                                    3116
                                                                                                    end exclusive
                                                                                                    true
                                                                                                    exact text
                                                                                                    Trichinosis with neurologic or myocardial involvement.
                                                                                                    label id
                                                                                                    e4a8e5b4-af77-4eca-92de-cd0982969b82
                                                                                                    offset unit
                                                                                                    unicode_code_points
                                                                                                    source array index
                                                                                                    0
                                                                                                    source field
                                                                                                    indications_and_usage_exact
                                                                                                    source text sha256
                                                                                                    c573dae6001e76b69e5f220c6c63d773da35dc743c564c184e94a81a114c336e
                                                                                                    start
                                                                                                    3062
                                                                                                    source url
                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22e4a8e5b4-af77-4eca-92de-cd0982969b82%22
                                                                                                    spl effective date
                                                                                                    2025-11-14
                                                                                                    spl set id
                                                                                                    39d5270b-d957-4821-93d6-501b7b9f02d4
                                                                                                    spl version
                                                                                                    25
                                                                                                    structured fields status
                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                    structured indication
                                                                                                    age
                                                                                                    Source null
                                                                                                    approval pathway
                                                                                                    Source null
                                                                                                    biomarker and test
                                                                                                    Source null
                                                                                                    disease stage
                                                                                                    Source null
                                                                                                    limitations
                                                                                                    Source null
                                                                                                    line
                                                                                                    Source null
                                                                                                    prior therapy
                                                                                                    Source null
                                                                                                    regimen
                                                                                                    Source null
                                                                                                    tumor histology
                                                                                                    Source null
                                                                                                    use intent
                                                                                                    unclear

                                                                                                    Preserved source evidence · Not medical advice