Time Frame |
Adverse events (AEs) were recorded throughout treatment to the safety evaluation follow up 4 weeks after treatment discontinuation, for up to 28 weeks.
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Adverse Event Reporting Description |
The safety assessment population included all eligible participants who received at least 1 dose of study treatment.
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Arm/Group Title
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MMF Monotherapy
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Arm/Group Description |
Participants received an initial do...
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Arm/Group Description |
Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
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MMF Monotherapy
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Affected / at Risk (%) |
Total |
--/-- |
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MMF Monotherapy
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Affected / at Risk (%) |
Total |
20/45 (44.44%) |
Blood and lymphatic system disorders |
|
Leucopenia |
1/45 (2.22%) |
Lymphocele |
15/45 (33.33%) |
Gastrointestinal disorders |
|
Vomiting |
1/45 (2.22%) |
General disorders |
|
Edema of the left leg |
1/45 (2.22%) |
Infections and infestations |
|
CMV infection |
3/45 (6.67%) |
Infection due to Legionella and Pseudomonas |
1/45 (2.22%) |
Sepsis |
1/45 (2.22%) |
Proteus mirabilis infection |
1/45 (2.22%) |
Gastrointestinal infection |
1/45 (2.22%) |
Injury, poisoning and procedural complications |
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Acute rejection |
3/45 (6.67%) |
Acute vascular and interstitial rejection |
1/45 (2.22%) |
Investigations |
|
Increase in creatinine |
2/45 (4.44%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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Prostatic adenocarcinoma |
1/45 (2.22%) |
Carcinoma of the bladder |
1/45 (2.22%) |
Renal and urinary disorders |
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Acute renal failure |
1/45 (2.22%) |
Tubulitis |
1/45 (2.22%) |
Ureteral stenosis |
1/45 (2.22%) |
Urinary anastomotic leak |
1/45 (2.22%) |
Acute tubular necrosis |
2/45 (4.44%) |
Hydronephrosis |
1/45 (2.22%) |
Indicates events were collected by non-systematic assessment
Term from vocabulary, WHO Guidelines
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Frequency Threshold for Reporting Other Adverse Events
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0%
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MMF Monotherapy
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Affected / at Risk (%) |
Total |
43/45 (95.56%) |
Blood and lymphatic system disorders |
|
Leukopenia |
13/45 (28.89%) |
Anaemia |
10/45 (22.22%) |
Lymphocele |
1/45 (2.22%) |
Antithrombin III deficiency |
2/45 (4.44%) |
Thrombocytopenia |
2/45 (4.44%) |
Iron deficiency anaemia |
1/45 (2.22%) |
Lymphocytopenia |
1/45 (2.22%) |
Acidosis |
1/45 (2.22%) |
Coagulopathy |
1/45 (2.22%) |
Cardiac disorders |
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Angina pectoris |
1/45 (2.22%) |
Erythema |
1/45 (2.22%) |
Tachycardia |
1/45 (2.22%) |
Gastrointestinal disorders |
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Vomiting |
5/45 (11.11%) |
Diarrhoea |
7/45 (15.56%) |
Abdominal pain |
2/45 (4.44%) |
Gastritis |
1/45 (2.22%) |
Gastritis erosive |
1/45 (2.22%) |
Gingival hyperplasia |
1/45 (2.22%) |
Haemorrhoids |
1/45 (2.22%) |
Dyspepsia |
1/45 (2.22%) |
Nausea |
1/45 (2.22%) |
Stomatitis |
1/45 (2.22%) |
Anal fissure |
1/45 (2.22%) |
Intra-abdominal haematoma |
1/45 (2.22%) |
Oral herpes |
1/45 (2.22%) |
General disorders |
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Pyrexia |
12/45 (26.67%) |
Oedema peripheral |
4/45 (8.89%) |
Asthenia |
1/45 (2.22%) |
Hearing impaired |
1/45 (2.22%) |
Ear pain |
1/45 (2.22%) |
Pharyngolaryngeal pain |
1/45 (2.22%) |
Hepatobiliary disorders |
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Cholestasis |
1/45 (2.22%) |
Lipidosis |
1/45 (2.22%) |
Infections and infestations |
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Urinary tract infection |
22/45 (48.89%) |
Cytomegalovirus infection |
9/45 (20.00%) |
Catheter related infection |
1/45 (2.22%) |
Tracheitis |
1/45 (2.22%) |
Urethritis |
1/45 (2.22%) |
Cytomegalovirus viraemia |
1/45 (2.22%) |
Injury, poisoning and procedural complications |
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Post-procedural haemorrhage |
1/45 (2.22%) |
Investigations |
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Blood creatinine increased |
8/45 (17.78%) |
Blood cholesterol increased |
3/45 (6.67%) |
White blood cell count decreased |
2/45 (4.44%) |
Alanine aminotransferase increased |
1/45 (2.22%) |
Blood bilirubin increased |
1/45 (2.22%) |
Metabolism and nutrition disorders |
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Hypokalaemia |
8/45 (17.78%) |
Hyperuricaemia |
7/45 (15.56%) |
Hypercholesterolemia |
4/45 (8.89%) |
Hyperlipemia |
3/45 (6.67%) |
Hypocalcaemia |
2/45 (4.44%) |
Diabetes mellitus |
1/45 (2.22%) |
Iron deficiency |
1/45 (2.22%) |
Musculoskeletal and connective tissue disorders |
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Arthralgia |
1/45 (2.22%) |
Myalgia |
1/45 (2.22%) |
Myopathy |
1/45 (2.22%) |
Rhabdomyolysis |
1/45 (2.22%) |
Nervous system disorders |
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Headache |
2/45 (4.44%) |
Paraesthesia |
1/45 (2.22%) |
Psychiatric disorders |
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Insomnia |
5/45 (11.11%) |
Anxiety |
1/45 (2.22%) |
Renal and urinary disorders |
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Renal colic |
2/45 (4.44%) |
Dysuria |
1/45 (2.22%) |
Haematuria |
2/45 (4.44%) |
Nocturia |
1/45 (2.22%) |
Glomerulosclerosis |
1/45 (2.22%) |
Renal artery stenosis |
1/45 (2.22%) |
Perirenal haematoma |
1/45 (2.22%) |
Respiratory, thoracic and mediastinal disorders |
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Cough |
2/45 (4.44%) |
Bronchitis |
1/45 (2.22%) |
Dyspnoea |
1/45 (2.22%) |
Skin and subcutaneous tissue disorders |
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Acarodermatitis |
1/45 (2.22%) |
Pruritus |
1/45 (2.22%) |
Surgical and medical procedures |
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Wound haemorrhage |
1/45 (2.22%) |
Operative haemorrhage |
1/45 (2.22%) |
Vascular disorders |
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Hypertension |
6/45 (13.33%) |
Arteriovenous fistula |
1/45 (2.22%) |
Arteriovenous fistula thrombosis |
1/45 (2.22%) |
Indicates events were collected by non-systematic assessment
Term from vocabulary, WHO Guidelines
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