Skip to main content

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.
Back to article page

Transplantation Research

ISSN: 2047-1440

Contact us