Table 2.
Occurrence of severe adverse events of interest.
Severe adverse events of interest | Probable-LAM | TSC-LAM |
---|---|---|
N | 208 | 33 |
Cytopenia requiring hospitalization: | 10 (4.8%) | 2 (6.1%) |
Anemia | 8 (3.9%) | 1 (3.0%) |
Neutropenia | 2 (1.0%) | 1 (3.0%) |
Thrombocytopenia | 0 | 0 |
Pneumonia requiring hospitalizations | 16 (7.7%) | 1 (3.0%) |
Opportunistic infections requiring hospitalization | 10 (4.8%) | 2 (6.1%) |
Initiation of lipid lowering therapies within 6 M after sirolimus initiation | 7 (3.4%) | 2 (6.1%) |
Lymphomas or skin cancers | 3 (1.4%) | 0 |
Respiratory tract hemorrhage requiring hospitalization | 1 (0.5%) | 0 |
High blood pressure flare-ups requiring hospitalization | 1 (0.5%) | 1 (3.0%) |
Hospitalization for hypercholesterolemia after sirolimus initiation | 1 (0.5%) | 0 |
Hospitalization for hypercholesterolemia within 1 year after sirolimus initiation | 1 (0.5%) | 0 |
Multifocal leukoencephalopathies requiring hospitalization | 0 | 0 |
Drug-induced interstitial lung disorders | 0 | 0 |