Table 4.

Reports of AEs and SAEs

Adverse EventMMF Therapy (52 reports, 20 patients) CsA Therapy (59 reports, 21 patients)
Infections
 Acute respiratory infection, bronchitis, otitis media20 (1 SAE)19 (3 SAE)
 Streptococcus infection22
 Herpes simplex3 (1 SAE)1
 Stomatitis1
 Enteritis76 (1 SAE)
 Acute hepatitis1 (SAE)
 Urinary tract infection2
Abdominal pain/vomiting
 Hyperemesis, no appetite42
Skin/hair/mucous membrane affections
 Hypertrichosis8
 Hyperplasia of the gingiva4
 Alopecia11
 Verrucae2
 Eczema/dry skin31
Muscle/articulation
 Muscle pain/tremor11
 Joint pain22
Psychiatry/neurology
 Sleep disorder1
 Mood changes11
Other
 Anemia11
 Leukopenia1
 Low magnesium level1
 Miscellaneousa53
  • AE, adverse events; SAE, serious adverse events.

  • a A detailed account of miscellaneous side effects is given in the Supplemental Material.