Female patients reported a higher incidence of skin events, including rash, in both EXTRANEAL and dextrose control treatment groups.

Table 1 shows the adverse events reported in these clinical studies, regardless of causality, occurring in ≥ 5% of patients and more common on EXTRANEAL than control.

Table 1 - Adverse Experiences in ≥5% of Patients and More
Common on EXTRANEAL
 EXTRANEAL Control
 N=493 N=347
Peritonitis 26% 25%
Upper respiratory infection 15% 13%
Hypertension 13% 8%
Rash 10% 5%
Headache 9% 7%
Abdominal pain 8% 6%
Flu Syndrome 7% 6%
Nausea 7% 5%
Cough increase 7% 4%
Edema 6% 5%
Accidental injury 6% 4%
Chest pain 5% 4%
Dyspepsia 5% 4%
Hyperglycemia 5% 4%

Adverse reactions reported with an incidence of > 5% and at least as common on dextrose control included pain, asthenia, exit site infection, infection, back pain, hypotension, diarrhea, vomiting, nausea/vomiting, anemia, peripheral edema, hypokalemia, hyperphosphatemia, hypoproteinemia, hypervolemia, arthralgia, dizziness, dyspnea, skin disorder, pruritis.

Additional adverse events occurring at an incidence of < 5% and that may or may not have been related to EXTRANEAL include: pain on infusion, abdominal enlargement, cloudy effluent, ultrafiltration decrease, postural hypotension, heart failure, hyponatremia, hypochloremia, hypercalcemia, hypoglycemia, alkaline phosphatase increase, SGPT increase, SGOT increase, cramping, confusion, lung edema, facial edema, exfoliative dermatitis, eczema, vesicobullous rash, maculopapular rash, erythema multiforme. All reported events are included in the list except those already listed in Table 1 or the following two paragraphs, those not plausibly associated with EXTRANEAL, and those that were associated with the condition being treated or related to the dialysis procedure.

EXTRANEAL was additionally studied in a subpopulation of 92 high average/high transporter APD patients in a two-week controlled clinical trial where patients received a single daily exchange of EXTRANEAL (n=47) or dextrose control (n=45) for the long dwell (14 ± 2 hours). Consistent with the data reported in the original trials of EXTRANEAL, rash was the most frequently occurring event.

Peritoneal Dialysis-Related
Adverse events common to the peritoneal dialysis, including peritonitis, infection around the catheter, fluid and electrolyte imbalance, and pain, were observed at a similar frequency with EXTRANEAL and Controls (See PRECAUTIONS).

Changes in Alkaline Phosphatase and Serum Electrolytes
An increase in mean serum alkaline phosphatase has been observed in clinical studies of ESRD patients receiving EXTRANEAL. No associated increases in other liver chemistry tests were observed. Serum alkaline phosphatase levels did not show progressive increase over a 12-month study period. Levels returned to normal approximately two weeks after discontinuation of EXTRANEAL.

Decreases in serum sodium and chloride have been observed in patients using EXTRANEAL. The declines in serum sodium and chloride may be related to dilution resulting from the p