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Table 5 Summary of adverse events over 12 months of treatment (safety population)

From: Efficacy and safety of concentration-controlled everolimus with reduced-dose cyclosporine in Japanese de novo renal transplant patients: 12-month results

  Everolimus 1.5 mg (n= 61) MMF 2 g (n= 61) Risk ratio (95% CI)
Any adverse event 61 (100) 61 (100)
Serious adverse events 27 (44.3) 33 (54.1) 0.82 (0.568, 1.178)
Severe adverse events 7 (11.5) 8 (13.1) 0.88 (0.338, 2.263)
Adverse events leading to study drug discontinuationa 3 (4.9%) 1 (1.6%) 3.00 (0.321, 28.044)
Adverse events leading to study drug dose adjustment/interruption 15 (24.6) 52 (85.2) 0.29 (0.184, 0.453)
Most frequently reported adverse events and infections (≥20% of patients in any treatment group) b
Hyperlipidemia 28 (45.9) 19 (31.1) 1.47 (0.928, 2.339)
Nasopharyngitis 21 (34.4) 26 (42.6) 0.81 (0.514, 1.270)
Constipation 19 (31.1) 27 (44.3) 0.70 (0.441, 1.123)
Hypertension 19 (31.1) 18 (29.5) 1.06 (0.616, 1.808)
Insomnia 17 (27.9) 9 (14.8) 1.89 (0.914, 3.903)
Acne 15 (24.6) 22 (36.1) 0.68 (0.393, 1.184)
Headache 13 (21.3) 9 (14.8) 1.44 (0.667, 3.127)
Toxic nephropathy 13 (21.3) 6 (9.8) 2.17 (0.881, 5.329)
Blood alkaline phosphatase increased 13 (21.3) 7 (11.5) 1.86 (0.796, 4.334)
Pyrexia 13 (21.3) 12 (19.7) 1.08 (0.538, 2.181)
Iron deficiency anemia 12 (19.7) 13 (21.3) 0.92 (0.458, 1.858)
Diarrhea 11 (18.0) 15 (24.6) 0.73 (0.367, 1.466)
Increased blood creatinine 11 (18.0) 14 (23.0) 0.79 (0.388, 1.591)
Hyperuricemia 7 (11.5) 13 (21.3) 0.54 (0.231, 1.257)
Cytomegalovirus test positive 4 (6.6) 19 (31.1) 0.21 (0.076, 0.583)
Cytomegalovirus infection 3 (4.9) 21 (34.4) 0.14 (0.045, 0.454)
Other adverse events of interest
Cyclosporine-associated adverse events
 Gingival hypertrophy 0 (0.0) 2 (3.3%)
 Gingival injury 0 (0.0) 1 (1.6%)
 Gingivitis 0 (0.0) 1 (1.6%)
 Tremor 4 (6.6%) 1 (1.6%) 4.00 (0.460, 34.767)
 Hirsutism 1 (1.6%) 4 (6.6%) 0.25 (0.029, 2.173)
 Hypertrichosis 2 (3.3%) 3 (4.9%) 0.67 (0.115, 3.850)
Everolimus-associated adverse events
 Wound-healing eventc 24 (39.3) 7 (11.5) 3.43 (1.598, 7.357)
 New-onset diabetesc 7 (11.5) 3 (4.9) 2.33 (0.633, 8.606)
 Edema eventsc 20 (32.8) 8 (13.1) 2.50 (1.194, 5.235)
 Stomatitis eventsc 14 (23.0) 10 (16.4) 1.40 (0.675, 2.904)
 Blood luteinizing hormone increased 9 (14.8) 0 (0.0)
 Blood follicle stimulating hormone increased 8 (13.1) 1 (1.6) 8.00 (1.032, 62.040)
 Proteinuria 8 (13.1) 5 (8.2) 1.60 (0.555, 4.616)
Investigator-reported severity    
 Mild 6 (9.8) 3 (4.9) 2.00 (0.524, 7.636)
 Moderate 2 (3.3) 1 (1.6) 2.00 (0.186, 21.482)
 Severe 0 (0.0) 1 (1.6)
  1. Data are presented as n (%). aFor patients with adverse events leading to discontinuation of study medication (recorded on the AE/Infection CRF page), the primary discontinuation reason (recorded on the End of Treatment CRF page) is not necessarily ‘AE(s)’; rather, it may be ‘abnormal laboratory result(s)’ or ‘unsatisfactory therapeutic effect’. bBy preferred term. cEvents were identified from a predefined list of adverse event preferred terms. MMF, mycophenolate mofetil.