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CSR
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CSR
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Complete Stable Remission (CSR) – The patient has no symptoms or signs of MG for at least 1 year and has received no therapy for MG during that time. There is no weakness of any muscle on careful examination by someone skilled in the evaluation of neuromuscular disease. Isolated weakness of eye closure is accepted.
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Died of MG
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Died of MG
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Died of MG (D of MG) – Patients who died of MG, of complications of MG therapy, or within 30 days after thymectomy. List the cause.
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Exacerbation
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Exacerbation
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Exacerbation (E) – Patients who have fulfilled criteria for CSR, PR, or MM but subsequently developed clinical findings greater than permitted by these criteria. In prospective studies, this should be defined in terms of a change in a predetermined quantitative score.
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Improved
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Improved
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Improved (I) – A substantial decrease in pre-treatment clinical manifestations or a sustained substantial reductions in MG medications as defined in the protocol. In prospective studies, this should be defined as a specific decrease in a predetermined quantitative score, if the patient has not met minimal manifestations or better.
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MM-0
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MM-0
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Minimal Manifestation (MM) – The patient has no symptoms or functional limitations from MG but has some weakness on examination of some muscles. This class recognizes that some patients who otherwise meet the definition of CSR or PR do have weakness that is only detectable by careful examination. MM-0: The patient has received no MG treatment for at least [1 year]. The duration of post-intervention status of outcome is left to the discretion of the Investigator, but should be predetermined.
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MM-1
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MM-1
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Minimal Manifestation (MM) – The patient has no symptoms or functional limitations from MG but has some weakness on examination of some muscles. This class recognizes that some patients who otherwise meet the definition of CSR or PR do have weakness that is only detectable by careful examination. MM-1: The patient continues to receive some form of immunosuppression but no cholinesterase inhibitors or other symptomatic therapy.
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MM-2
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MM-2
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Minimal Manifestation (MM) – The patient has no symptoms or functional limitations from MG but has some weakness on examination of some muscles. This class recognizes that some patients who otherwise meet the definition of CSR or PR do have weakness that is only detectable by careful examination. MM-2: The patient has received only low dose cholinesterase inhibitors (< 120 mg pyridostigmine per day), for at least [1 year]. The duration of post-intervention status of outcome is left to the discretion of the Investigator, but should be predetermined.
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MM-3
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MM-3
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Minimal Manifestation (MM) – The patient has no symptoms or functional limitations from MG but has some weakness on examination of some muscles. This class recognizes that some patients who otherwise meet the definition of CSR or PR do have weakness that is only detectable by careful examination. MM-3: Patient has received cholinesterase inhibitors or other symptomatic therapy and some form of immunosuppression during the past year.
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PR
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PR
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Pharmacologic Remissions (PR) – The same criteria as for CSR except that the patient continues to take some form of therapy for MG. Patients taking cholinesterase inhibitors are excluded from this category because their use suggests the presence of weakness.
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Unchanged
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Unchanged
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Unchanged (U) – No substantial change in pre-treatment clinical manifestations or reduction in MG medications as defined in the protocol. In prospective studies, this should be defined in terms of a maximum change in a predetermined quantitative score, if the patient has not met minimal manifestations or better.
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Worse
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Worse
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Worse (W) – A substantial increase in pre-treatment clinical manifestations or a substantial increase in MG medications as defined in the protocol. In prospective studies, this should be defined as a specific increase in a predetermined quantitative score.
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