FDA label cbb7cff7-62dd-4bb5-aee5-4202eb730940

Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication. (See WARNINGS ). The primary toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that has lead to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin. (See WARNINGS , ADVERSE REACTIONS , and DOSAGE AND ADMINISTRATION ). Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple-dose half-life of 12 days, and so it may persist in nonplasma compartments for as long as 6 months. Therefore, ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month posttreatment follow-up period. (See CONTRAINDICATIONS , WARNINGS , PRECAUTIONS : Information for Patients and Pregnancy Category X ).

CONTRAINDICATIONS AND WARNINGS Combination ribavirin capsules/INTRON A therapy is contraindicated in females who are pregnant and in the male partners of females who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in female patients, and in female partners of male patients who are taking combination ribavirin capsules/INTRON A therapy. Females of childbearing potential and males must use two reliable forms of effective contraception during treatment and during the 6-month posttreatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species studied. See CONTRAINDICATIONS and WARNINGS . Ribavirin capsules monotherapy is not effective for the treatment of chronic hepatitis C and should not be used for this indication. See WARNINGS . Alpha interferons, including INTRON A, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping INTRON A therapy. See WARNINGS and ADVERSE REACTIONS .

WARNINGS Based on results of clinical trials ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection; therefore, ribavirin capsules must not be used alone. The safety and efficacy of ribavirin capsules with non-pegylated interferons other than INTRON A product have not been established. There are significant adverse events caused by ribavirin/INTRON A therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes. Suicidal ideation or attempts occurred more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% versus 1%) during treatment and off-therapy follow-up. The Appendix to this package insert should be reviewed in its entirety prior to initiation of therapy of ribavirin capsules taken together with INTRON A for additional safety information. Pregnancy Ribavirin capsules may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin capsules have demonstrated significant teratogenic and/or embryocidal effects in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of ribavirin. RIBAVIRIN THERAPY SHOULD NOT BE STARTED UNTIL A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO PLANNED INITIATION OF THERAPY. Patients should be instructed to use at least two forms of effective contraception during treatment and during the six month period after treatment has been stopped based on multiple dose half-life of ribavirin of 12 days. Pregnancy testing should occur monthly during ribavirin therapy and for six months after therapy has stopped (see CONTRAINDICATIONS and PRECAUTIONS : Information for Patients and Pregnancy Category X ). Anemia The primary toxicity of ribavirin is hemolytic anemia, which was observed in approximately 10% of ribavirin/INTRON A-treated patients in clinical trials (see ADVERSE REACTIONS : Laboratory Values : Hemoglobin ). The anemia associated with ribavirin capsules occurs within 1 to 2 weeks of initiation of therapy. BECAUSE THE INITIAL DROP IN HEMOGLOBIN MAY BE SIGNIFICANT, IT IS ADVISED THAT HEMOGLOBIN OR HEMATOCRIT BE OBTAINED PRETREATMENT AND AT WEEK 2 AND WEEK 4 OF THERAPY, OR MORE FREQUENTLY IF CLINICALLY INDICATED. Patients should then be followed as clinically appropriate. Fatal and nonfatal myocardial infarctions have been reported in patients with anemia caused by ribavirin. Patients should be assessed for underlying cardiac disease before initiation of ribavirin therapy. Patients with pre-existing cardiac disease should have electrocardiograms administered before treatment, and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be suspended or discontinued. (See DOSAGE AND ADMINISTRATION : Guidelines for Dose Modification). Because cardiac disease may be worsened by drug induced anemia, patients with a history of significant or unstable cardiac disease should not use ribavirin. (See ADVERSE REACTIONS ). Ribavirin and INTRON A therapy should be suspended in patients with signs and symptoms of pancreatitis and discontinued in patients with confirmed pancreatitis. Ribavirin should not be used in patients with creatinine clearance <50 mL/min. (See CLINICAL PHARMACOLOGY : Special Populations ). Pulmonary Pulmonary symptoms, including dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, have been reported during therapy with ribavirin/INTRON A; occasional cases of fatal pneumonia have occurred. In addition, sarcoidosis or the exacerbation of sarcoidosis has been reported. If there is evidence of pulmonary infiltrates or pulmonary function impairment, the patient should be closely monitored, and if appropriate, combination ribavirin/INTRON A treatment should be discontinued. Dental and Periodontal Disorders Dental and periodontal disorders have been reported in patients receiving ribavirin and interferon combination therapy. In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of ribavirin capsules and interferon alfa-2b. Patients should brush their teeth thoroughly twice daily and have regular dental examinations. In addition, some patients may experience vomiting. If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.

WARNINGS Pregnancy Category X, may cause birth defects. See boxed CONTRAINDICATIONS AND WARNINGS. See CONTRAINDICATIONS . Anemia HEMOLYTIC ANEMIA (HEMOGLOBIN <10 G/DL) WAS OBSERVED IN APPROXIMATELY 10% OF RIBAVIRIN CAPSULES/INTRON A-TREATED PATIENTS IN CLINICAL TRIALS (See ADVERSE REACTIONS : Laboratory Values : Hemoglobin ). ANEMIA OCCURRED WITHIN 1 TO 2 WEEKS OF INITIATION OF RIBAVIRIN THERAPY. BECAUSE OF THIS INITIAL ACUTE DROP IN HEMOGLOBIN, IT IS ADVISED THAT COMPLETE BLOOD COUNTS (CBC) SHOULD BE OBTAINED PRETREATMENT AND AT WEEK 2 AND WEEK 4 OF THERAPY OR MORE FREQUENTLY IF CLINICALLY INDICATED. PATIENTS SHOULD THEN BE FOLLOWED AS CLINICALLY APPROPRIATE. The anemia associated with ribavirin capsules/INTRON A therapy may result in deterioration of cardiac function and/or exacerbation of the symptoms of coronary disease. Patients should be assessed before initiation of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be suspended or discontinued. (See DOSAGE AND ADMINISTRATION .) Because cardiac disease may be worsened by drug induced anemia, patients with a history of significant or unstable cardiac disease should not use combination ribavirin capsules/INTRON A therapy. (See ADVERSE REACTIONS .) Similarly, patients with hemoglobinopathies (e.g., thalassemia, sickle-cell anemia) should not be treated with combination ribavirin capsules/INTRON A therapy. Psychiatric Severe psychiatric adverse events, including depression, psychoses, aggressive behavior, hallucinations, violent behavior (suicidal ideation, suicidal attempts, suicides) and rare instances of homicidal ideation have occurred during combination ribavirin capsules/Intron A therapy, both in patients with and without a previous psychiatric disorder. Ribavirin capsules/Intron A therapy should be used with extreme caution in patients with a history of pre-existing psychiatric disorders, and all patients should be carefully monitored for evidence of depression and other psychiatric symptoms. Suspension of ribavirin capsules/Intron A therapy should be considered if psychiatric intervention and/or dose reduction is unsuccessful in controlling psychiatric symptoms. In severe cases, therapy should be stopped immediately and psychiatric intervention sought. (See ADVERSE REACTIONS .) Bone Marrow Toxicity INTRON A therapy suppresses bone marrow function and may result in severe cytopenias including very rare events of aplastic anemia. It is advised that complete blood counts (CBC) be obtained pretreatment and monitored routinely during therapy (see PRECAUTIONS : Laboratory Tests ). INTRON A therapy should be discontinued in patients who develop severe decreases in neutrophil (<0.5 x 10 9 /L) or platelet counts (<25 x 10 9 /L) (see DOSAGE AND ADMINISTRATION : Guidelines for Dose Modifications ). Pulmonary Pulmonary symptoms, including dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, have been reported during therapy with ribavirin capsules/INTRON A; occasional cases of fatal pneumonia have occurred. In addition, sarcoidosis or the exacerbation of sarcoidosis has been reported. If there is evidence of pulmonary infiltrates or pulmonary function impairment, the patient should be closely monitored, and if appropriate, combination ribavirin capsules/INTRON A treatment should be discontinued. Other Ribavirin capsules monotherapy is not effective for the treatment of chronic hepatitis C and should not be used for this indication. Fatal and nonfatal pancreatitis has been observed in patients treated with ribavirin capsules/INTRON A therapy. Ribavirin capsules/INTRON A therapy should be suspended in patients with signs and symptoms of pancreatitis and discontinued in patients with confirmed pancreatitis. Combination ribavirin capsules/INTRON A therapy should not be used in patients with creatinine clearance <50 mL/min. Diabetes mellitus and hyperglycemia have been observed in patients treated with INTRON A. Ophthalmologic disorders have been reported with treatment with alpha interferons (including INTRON A therapy). Investigators using alpha interferons have reported the occurrence of retinal hemorrhages, cotton wool spots, and retinal artery or vein obstruction in rare instances. Any patient complaining of loss of visual acuity or visual field should have an eye examination. Because these ocular events may occur in conjunction with other disease states, a visual exam prior to initiation of combination ribavirin capsules/INTRON A therapy is recommended in patients with diabetes mellitus or hypertension. Acute serious hypersensitivity reactions (eg, urticaria, angioedema, bronchoconstriction, anaphylaxis) have been observed in INTRON A-treated patients; if such an acute reaction develops, combination ribavirin capsules/INTRON A therapy should be discontinued immediately and appropriate medical therapy instituted. Combination ribavirin capsules/INTRON A therapy should be discontinued for patients developing thyroid abnormalities during treatment whose thyroid function cannot be controlled by medication.

ADVERSE REACTIONS The primary toxicity of ribavirin is hemolytic anemia. Reductions in hemoglobin levels occurred within the first 1 to 2 weeks of oral therapy. (See WARNINGS ). Cardiac and pulmonary events associated with anemia occurred in approximately 10% of patients (See WARNINGS ). Ribavirin/INTRON A Combination Therapy In clinical trials, 19% and 6% of previously untreated and relapse patients, respectively, discontinued therapy due to adverse events in the combination arms compared to 13% and 3% in the interferon arms. Selected treatment-emergent adverse events that occurred in the US studies with ≥5% incidence are provided in TABLE 4 by treatment group. In general, the selected treatment-emergent adverse events were reported with lower incidence in the international studies as compared to the US studies with the exception of asthenia, influenza-like symptoms, nervousness, and pruritus. TABLE 4. Selected Treatment-Emergent Adverse Events: Previously Untreated and Relapse Adult Patients Percentage of Patients US Previously Untreated Study US Relapse Study 24 weeks of treatment 48 weeks of treatment 24 weeks of treatment Patients Reporting Adverse Events Patients reporting one or more adverse events. A patient may have reported more than one adverse event within a body system/organ class category. INTRON A plus Ribavirin (N=228) INTRON A plus Placebo (N=231) INTRON A plus Ribavirin (N=228) INTRON A plus Placebo (N=225) INTRON A plus Ribavirin (N=77) INTRON A plus Placebo (N=76) Application Site Disorders Injection site inflammation 13 10 12 14 6 8 Injection site reaction 7 9 8 9 5 3 Body as a Whole – General Disorders Headache 63 63 66 67 66 68 Fatigue 68 62 70 72 60 53 Rigors 40 32 42 39 43 37 Fever 37 35 41 40 32 36 Influenza-like symptoms 14 18 18 20 13 13 Asthenia 9 4 9 9 10 4 Chest pain 5 4 9 8 6 7 Central & Peripheral Nervous System Disorders Dizziness 17 15 23 19 26 21 Gastrointestinal System Disorders Nausea 38 35 46 33 47 33 Anorexia 27 16 25 19 21 14 Dyspepsia 14 6 16 9 16 9 Vomiting 11 10 9 13 12 8 TABLE 4. Selected Treatment-Emergent Adverse Events: Previously Untreated and Relapse Adult Patients (continued) Percentage of Patients US Previously Untreated Study US Relapse Study 24 weeks of treatment 48 weeks of treatment 24 weeks of treatment Patients Reporting Adverse Events Patients reporting one or more adverse events. A patient may have reported more than one adverse event within a body system/organ class category. INTRON A plus Ribavirin (N=228) INTRON A plus Placebo (N=231) INTRON A plus Ribavirin (N=228) INTRON A plus Placebo (N=225) INTRON A plus Ribavirin (N=77) INTRON A plus Placebo (N=76) Musculoskeletal System Disorders Myalgia 61 57 64 63 61 58 Arthralgia 30 27 33 36 29 29 Musculoskeletal pain 20 26 28 32 22 28 Psychiatric Disorders Insomnia 39 27 39 30 26 25 Irritability 23 19 32 27 25 20 Depression 32 25 36 37 23 14 Emotional lability 7 6 11 8 12 8 Concentration impaired 11 14 14 14 10 12 Nervousness 4 2 4 4 5 4 Respiratory System Disorders Dyspnea 19 9 18 10 17 12 Sinusitis 9 7 10 14 12 7 Skin and Appendages Disorders Alopecia 28 27 32 28 27 26 Rash 20 9 28 8 21 5 Pruritus 21 9 19 8 13 4 Special Senses, Other Disorders Taste perversion 7 4 8 4 6 5 In addition, the following spontaneous adverse events have been reported during the marketing surveillance of ribavirin/INTRON A therapy: hearing disorder and vertigo. Laboratory Values Ribavirin/INTRON A Combination Therapy Changes in selected hematologic values (hemoglobin, white blood cells, neutrophils, and platelets)during therapy are described below. (See TABLE 5 ). Hemoglobin Hemoglobin decreases among patients receiving ribavirin therapy began at Week 1, with stabilization by Week 4. In previously untreated patients treated for 48 weeks, the mean maximum decrease from baseline was 3.1 g/dL in the US study and 2.9 g/dL in the International study. In relapse patients, the mean maximum decrease from baseline was 2.8 g/dL in the US study and 2.6 g/dL in the international study. Hemoglobin values returned to pretreatment levels within 4 to 8 weeks of cessation of therapy in most patients. Bilirubin and Uric Acid Increases in both bilirubin and uric acid, associated with hemolysis, were noted in clinical trials. Most were moderate biochemical changes and were reversed within 4 weeks after treatment discontinuation. This observation occurs most frequently in patients with a previous diagnosis of Gilbert’s syndrome. This has not been associated with hepatic dysfunction or clinical morbidity. TABLE 5. Selected Hematologic Values During Treatment with Ribavirin Capsules plus INTRON A: Previously Untreated and Relapse Adult Patients Percentage of Patients US Previously Untreated Study US Relapse Study 24 weeks of treatment 48 weeks of treatment 24 weeks of treatment INTRON A plus Ribavirin (N=228) INTRON A plus Placebo (N=231) INTRON A plus Ribavirin (N=228) INTRON A plus Placebo (N=225) INTRON A plus Ribavirin (N=77) INTRON A plus Placebo (N=76) Hemoglobin (g/dL) 9.5-10.9 24 1 32 1 21 3 8.0-9.4 5 0 4 0 4 0 6.5-7.9 0 0 0 0.4 0 0 <6.5 0 0 0 0 0 0 Leukocytes (x10 9 /L) 2.0-2.9 40 20 38 23 45 26 1.5-1.9 4 1 9 2 5 3 1.0-1.4 0.9 0 2 0 0 0 <1.0 0 0 0 0 0 0 Neutrophils (x10 9 /L) 1.0-1.49 30 32 31 44 42 34 0.75-0.99 14 15 14 11 16 18 0.5-0.74 9 9 14 7 8 4 <0.5 11 8 11 5 5 8 Platelets (x10 9 /L) 70-99 9 11 11 14 6 12 50-69 2 3 2 3 0 5 30-49 0 0.4 0 0.4 0 0 <30 0.9 0 1 0.9 0 0 Total Bilirubin (mg/dL) 1.5-3.0 27 13 32 13 21 7 3.1-6.0 0.9 0.4 2 0 3 0 6.1-12.0 0 0 0.4 0 0 0 >12.0 0 0 0 0 0 0 Postmarketing Experiences The following adverse reactions have been identified during the post approval use of ribavirin capsules in combination with INTRON A: hearing disorder, vertigo, aplastic anemia and pure red cell aplasia. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

ADVERSE REACTIONS The safety of combination ribavirin capsules/INTRON A therapy was evaluated in controlled trials of 1010 HCV-infected adults who were previously untreated with interferon therapy and were subsequently treated for 24 or 48 weeks with combination ribavirin capsules/INTRON A therapy and in 173 HCV-infected patients who had relapsed after interferon therapy and were subsequently treated for 24 weeks with combination ribavirin capsules/INTRON A therapy. (See Description of Clinical Studies .) Overall, 19% and 6% of previously untreated and relapse patients, respectively, discontinued therapy due to adverse events in the combination arms compared to 13% and 3% in the interferon arms. The primary toxicity of ribavirin is hemolytic anemia. Reductions in hemoglobin levels occurred within the first 1 to 2 weeks of therapy (see WARNINGS ). Cardiac and pulmonary events associated with anemia occurred in approximately 10% of patients treated with ribavirin capsules/INTRON A therapy. (See WARNINGS .) The most common psychiatric events occurring in US studies of previously untreated and relapse patients treated with ribavirin capsules/INTRON A therapy, respectively, were insomnia (39%, 26%), depression (34%, 23%), and irritability (27%, 25%). Suicidal behavior (ideation, attempts, and suicides) occurred in 1% of patients. (See WARNINGS .) In addition, the following spontaneous adverse events have been reported during the marketing surveillance of ribavirin capsules/INTRON A therapy: hearing disorder and vertigo. Very rarely, combination ribavirin capsules/INTRON A therapy may be associated with aplastic anemia. Selected treatment-emergent adverse events that occurred in the US studies with ≥5% incidence are provided in TABLE 4 by treatment group. In general, the selected treatment-emergent adverse events reported with lower incidence in the international studies as compared to the US studies with the exception of asthenia, influenza-like symptoms, nervousness, and pruritus. TABLE 4. Selected Treatment-Emergent Adverse Events: Previously Untreated and Relapse Patients Percentage of Patients US Previously Untreated Study US Relapse Study 24 weeks of treatment 48 weeks of treatment 24 weeks of treatment Patients Reporting Adverse Events Patients reporting one or more adverse events. A patient may have reported more than one adverse event within a body system/organ class category. INTRON A plus Ribavirin capsules (N=228) INTRON A plus Placebo (N=231) INTRON A plus Ribavirin capsules (N=228) INTRON A plus Placebo (N=225) INTRON A plus Ribavirin capsules (N=77) INTRON A plus Placebo (N=76) Application Site Disorders Injection site inflammation 13 10 12 14 6 8 Injection site reaction 7 9 8 9 5 3 Body as a Whole – General Disorders Headache 63 63 66 67 66 68 Fatigue 68 62 70 72 60 53 Rigors 40 32 42 39 43 37 Fever 37 35 41 40 32 36 Influenza-like symptoms 14 18 18 20 13 13 Asthenia 9 4 9 9 10 4 Chest pain 5 4 9 8 6 7 Central & Peripheral Nervous System Disorders Dizziness 17 15 23 19 26 21 Gastrointestinal System Disorders Nausea 38 35 46 33 47 33 Anorexia 27 16 25 19 21 14 Dyspepsia 14 6 16 9 16 9 Vomiting 11 10 9 13 12 8 TABLE 4. Selected Treatment-Emergent Adverse Events: Previously Untreated and Relapse Patients (continued) Percentage of Patients US Previously Untreated Study US Relapse Study 24 weeks of treatment 48 weeks of treatment 24 weeks of treatment Patients Reporting Adverse Events Patients reporting one or more adverse events. A patient may have reported more than one adverse event within a body system/organ class category. INTRON A plus Ribavirin capsules (N=228) INTRON A plus Placebo (N=231) INTRON A plus Ribavirin capsules (N=228) INTRON A plus Placebo (N=225) INTRON A plus Ribavirin capsules (N=77) INTRON A plus Placebo (N=76) Musculoskeletal System Disorders Myalgia 61 57 64 63 61 58 Arthralgia 30 27 33 36 29 29 Musculoskeletal pain 20 26 28 32 22 28 Psychiatric Disorders Insomnia 39 27 39 30 26 25 Irritability 23 19 32 27 25 20 Depression 32 25 36 37 23 14 Emotional lability 7 6 11 8 12 8 Concentration impaired 11 14 14 14 10 12 Nervousness 4 2 4 4 5 4 Respiratory System Disorders Dyspnea 19 9 18 10 17 12 Sinusitis 9 7 10 14 12 7 Skin and Appendages Disorders Alopecia 28 27 32 28 27 26 Rash 20 9 28 8 21 5 Pruritus 21 9 19 8 13 4 Special Senses, Other Disorders Taste perversion 7 4 8 4 6 5 Laboratory Values Changes in selected hematologic values (hemoglobin, white blood cells, neutrophils, and platelets) during combination ribavirin capsules/INTRON A treatment are described below (see TABLE 5 ). Hemoglobin Hemoglobin decreases among patients on combination therapy began at Week 1, with stabilization by Week 4. In previously untreated patients treated for 48 weeks the mean maximum decrease from baseline was 3.1 g/dL in the US study and 2.9 g/dL in the International study. In relapse patients the mean maximum decrease from baseline was 2.8 g/dL in the US study and 2.6 g/dL in the International study. Hemoglobin values returned to pretreatment levels within 4 to 8 weeks of cessation of therapy in most patients. Neutrophils There were decreases in neutrophil counts in both the combination ribavirin capsules/INTRON A and INTRON A plus placebo dose groups. In previously untreated patients treated for 48 weeks the mean maximum decrease in neutrophil count in the US study was 1.3x 10 9 /L and in the International study was 1.5 x 10 9 /L. In relapse patients the mean maximum decrease in neutrophil count in the US study was 1.3 x 10 9 /L and in the International study was 1.6 x 10 9 /L. Neutrophil counts returned to pretreatment levels within 4 weeks of cessation of therapy in most patients. Platelets In both previously untreated and relapse patients mean platelet counts generally remained in the normal range in all treatment groups, however, mean platelet counts were 10% to 15% lower in the INTRON A plus placebo group than the ribavirin capsules/INTRON A group. Mean platelet counts returned to baseline levels within 4 weeks after treatment discontinuation. Thyroid Function Of patients who entered the previously untreated (24 and 48 week treatment) and relapse (24 week treatment) studies without thyroid abnormalities, approximately 3% to 6% and 1% to 2%, respectively, developed thyroid abnormalities requiring clinical intervention. Bilirubin and Uric Acid Increases in both bilirubin and uric acid, associated with hemolysis, were noted in clinical trials. Most were moderate biochemical changes and were reversed within 4 weeks after treatment discontinuation. This observation occurs most frequently in patients with a previous diagnosis of Gilbert’s syndrome. This has not been associated with hepatic dysfunction or clinical morbidity. TABLE 5. Selected Hematologic Values During Treatment with Ribavirin Capsules plus INTRON A: Previously Untreated and Relapse Patients Percentage of Patients US Previously Untreated Study US Relapse Study 24 weeks of treatment 48 weeks of treatment 24 weeks of treatment INTRON A plus Ribavirin (N=228) INTRON A plus Placebo (N=231) INTRON A plus Ribavirin (N=228) INTRON A plus Placebo (N=225) INTRON A plus Ribavirin (N=77) INTRON A plus Placebo (N=76) Hemoglobin (g/dL) 9.5-10.9 24 1 32 1 21 3 8.0-9.4 5 0 4 0 4 0 6.5-7.9 0 0 0 0.4 0 0 <6.5 0 0 0 0 0 0 Leukocytes (x10 9 /L) 2.0-2.9 40 20 38 23 45 26 1.5-1.9 4 1 9 2 5 3 1.0-1.4 0.9 0 2 0 0 0 <1.0 0 0 0 0 0 0 Neutrophils (x10 9 /L) 1.0-1.49 30 32 31 44 42 34 0.75-0.99 14 15 14 11 16 18 0.5-0.74 9 9 14 7 8 4 <0.5 11 8 11 5 5 8 Platelets (x10 9 /L) 70-99 9 11 11 14 6 12 50-69 2 3 2 3 0 5 30-49 0 0.4 0 0.4 0 0 <30 0.9 0 1 0.9 0 0 Total Bilirubin (mg/dL) 1.5-3.0 27 13 32 13 21 7 3.1-6.0 0.9 0.4 2 0 3 0 6.1-12.0 0 0 0.4 0 0 0 >12.0 0 0 0 0 0 0

<table ID="ID_541B7003-4420-457E-BE78-31A0CBDFACCE" border="single" frame="box" width="623.000"> <caption ID="ID_5C6699E6-9F6F-47AF-B981-5D781E5E3A99">TABLE 4. Selected Treatment-Emergent Adverse Events: Previously Untreated and Relapse Adult Patients</caption> <col width="30.7%"/> <col width="11.6%"/> <col width="11.6%"/> <col width="11.6%"/> <col width="11.6%"/> <col width="11.6%"/> <col width="11.6%"/> <tbody> <tr ID="ID_8A0CC37E-4799-437C-80C4-BAB2BAD1E891"> <td align="left" styleCode="Toprule" valign="bottom"/> <td align="center" colspan="6" styleCode="Toprule" valign="bottom"> <content styleCode="bold">Percentage of Patients</content> </td> </tr> <tr ID="ID_B970327D-C04F-49F8-B30A-0AF85D09F7D8"> <td align="left" valign="bottom"/> <td align="center" colspan="4" valign="bottom"> <content styleCode="bold">US Previously Untreated Study</content> </td> <td align="center" colspan="2" valign="bottom"> <content styleCode="bold">US Relapse Study</content> </td> </tr> <tr ID="ID_9F59B0F9-83AA-45AD-BB87-2A83171431B4"> <td align="left" valign="bottom"/> <td align="center" colspan="2" valign="bottom"> <content styleCode="bold">24 weeks of treatment</content> </td> <td align="center" colspan="2" valign="bottom"> <content styleCode="bold">48 weeks of treatment</content> </td> <td align="center" colspan="2" valign="bottom"> <content styleCode="bold">24 weeks of treatment</content> </td> </tr> <tr ID="ID_460EE047-52DA-404C-808D-AA30CD7F65D2"> <td align="left" valign="bottom"> <paragraph> <content styleCode="bold">Patients Reporting</content> </paragraph> <content styleCode="bold">Adverse Events<footnote ID="ID-53C8D013-E5C7-4831-A1E2-182FBF6B78DD">Patients reporting one or more adverse events. A patient may have reported more than one adverse event within a body system/organ class category.</footnote> </content> </td> <td align="center" valign="bottom"> <paragraph> <content styleCode="bold">INTRON A</content> </paragraph> <paragraph> <content styleCode="bold">plus</content> </paragraph> <paragraph> <content styleCode="bold">Ribavirin</content> </paragraph> <content styleCode="bold">(N=228)</content> </td> <td align="center" valign="bottom"> <paragraph> <content styleCode="bold">INTRON A</content> </paragraph> <paragraph> <content styleCode="bold">plus</content> </paragraph> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <content styleCode="bold">(N=231)</content> </td> <td align="center" valign="bottom"> <paragraph> <content styleCode="bold">INTRON A</content> </paragraph> <paragraph> <content styleCode="bold">plus</content> </paragraph> <paragraph> <content styleCode="bold">Ribavirin</content> </paragraph> <content styleCode="bold">(N=228)</content> </td> <td align="center" valign="bottom"> <paragraph> <content styleCode="bold">INTRON A</content> </paragraph> <paragraph> <content styleCode="bold">plus</content> </paragraph> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <content styleCode="bold">(N=225)</content> </td> <td align="center" valign="bottom"> <paragraph> <content styleCode="bold">INTRON A</content> </paragraph> <paragraph> <content styleCode="bold">plus</content> </paragraph> <paragraph> <content styleCode="bold">Ribavirin</content> </paragraph> <content styleCode="bold">(N=77)</content> </td> <td align="center" valign="bottom"> <paragraph> <content styleCode="bold">INTRON A</content> </paragraph> <paragraph> <content styleCode="bold">plus</content> </paragraph> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <content styleCode="bold">(N=76)</content> </td> </tr> <tr ID="ID_5E1CD8B6-BC30-42A6-9B01-D7C1CB143001"> <td align="left" valign="bottom"> <content styleCode="bold">Application Site Disorders</content> </td> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> </tr> <tr ID="ID_4BD7C903-8F8F-42D3-AFC1-836D9B63F905"> <td align="left" valign="bottom">Injection site inflammation</td> <td align="center" valign="bottom">13</td> <td align="center" valign="bottom">10</td> <td align="center" valign="bottom">12</td> <td align="center" valign="bottom">14</td> <td align="center" valign="bottom"> 6</td> <td align="center" valign="bottom"> 8</td> </tr> <tr ID="ID_F1AE898D-8B6E-4125-A60B-B23AE1A286DF"> <td align="left" valign="bottom">Injection site reaction</td> <td align="center" valign="bottom"> 7</td> <td align="center" valign="bottom"> 9</td> <td align="center" valign="bottom"> 8</td> <td align="center" valign="bottom"> 9</td> <td align="center" valign="bottom"> 5</td> <td align="center" valign="bottom"> 3</td> </tr> <tr ID="ID_F13B19EE-93D3-4B8C-96B8-5E2D23720D36"> <td align="left" valign="bottom"> <paragraph> <content styleCode="bold">Body as a Whole </content>&#x2013;</paragraph> <content styleCode="bold">General Disorders</content> </td> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> </tr> <tr ID="ID_657F66BB-3F91-4FBE-85ED-68E752DA5834"> <td align="left" valign="bottom">Headache</td> <td align="center" valign="bottom">63</td> <td align="center" valign="bottom">63</td> <td align="center" valign="bottom">66</td> <td align="center" valign="bottom">67</td> <td align="center" valign="bottom">66</td> <td align="center" valign="bottom">68</td> </tr> <tr ID="ID_D29044D3-D517-4010-91BF-A3DA1A87100E"> <td align="left" valign="bottom">Fatigue</td> <td align="center" valign="bottom">68</td> <td align="center" valign="bottom">62</td> <td align="center" valign="bottom">70</td> <td align="center" valign="bottom">72</td> <td align="center" valign="bottom">60</td> <td align="center" valign="bottom">53</td> </tr> <tr ID="ID_8B050CE4-DDA6-418A-BD21-D5CEF98D8F52"> <td align="left" valign="bottom">Rigors</td> <td align="center" valign="bottom">40</td> <td align="center" valign="bottom">32</td> <td align="center" valign="bottom">42</td> <td align="center" valign="bottom">39</td> <td align="center" valign="bottom">43</td> <td align="center" valign="bottom">37</td> </tr> <tr ID="ID_C3E3FD8D-13AB-46F9-982A-4677AF62F7BF"> <td align="left" valign="bottom">Fever</td> <td align="center" valign="bottom">37</td> <td align="center" valign="bottom">35</td> <td align="center" valign="bottom">41</td> <td align="center" valign="bottom">40</td> <td align="center" valign="bottom">32</td> <td align="center" valign="bottom">36</td> </tr> <tr ID="ID_DD16A028-B171-412E-AC5F-6AEA0012A398"> <td align="left" valign="bottom">Influenza-like symptoms</td> <td align="center" valign="bottom">14</td> <td align="center" valign="bottom">18</td> <td align="center" valign="bottom">18</td> <td align="center" valign="bottom">20</td> <td align="center" valign="bottom">13</td> <td align="center" valign="bottom">13</td> </tr> <tr ID="ID_6046862D-8834-4011-A25B-054C7CB454E8"> <td align="left" valign="bottom">Asthenia</td> <td align="center" valign="bottom"> 9</td> <td align="center" valign="bottom"> 4</td> <td align="center" valign="bottom"> 9</td> <td align="center" valign="bottom"> 9</td> <td align="center" valign="bottom">10</td> <td align="center" valign="bottom"> 4</td> </tr> <tr ID="ID_EE84FE54-F15F-426C-B208-0DB424329329"> <td align="left" valign="bottom">Chest pain</td> <td align="center" valign="bottom"> 5</td> <td align="center" valign="bottom"> 4</td> <td align="center" valign="bottom"> 9</td> <td align="center" valign="bottom"> 8</td> <td align="center" valign="bottom"> 6</td> <td align="center" valign="bottom"> 7</td> </tr> <tr ID="ID_79597FC6-845C-4A3E-8EE6-AD42AA9B010E"> <td align="left" valign="bottom"> <paragraph> <content styleCode="bold">Central &amp; Peripheral</content> </paragraph> <content styleCode="bold">Nervous System Disorders</content> </td> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> </tr> <tr ID="ID_36DC596D-973C-476F-B28B-3E73089912D3"> <td align="left" valign="bottom">Dizziness</td> <td align="center" valign="bottom">17</td> <td align="center" valign="bottom">15</td> <td align="center" valign="bottom">23</td> <td align="center" valign="bottom">19</td> <td align="center" valign="bottom">26</td> <td align="center" valign="bottom">21</td> </tr> <tr ID="ID_60B5A85B-BCD7-4C8F-ABE7-AAC80F5B9133"> <td align="left" valign="bottom"> <content styleCode="bold">Gastrointestinal System Disorders</content> </td> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> </tr> <tr ID="ID_20810D70-630F-4FCD-997A-A2E6750CBCC8"> <td align="left" valign="bottom">Nausea</td> <td align="center" valign="bottom">38</td> <td align="center" valign="bottom">35</td> <td align="center" valign="bottom">46</td> <td align="center" valign="bottom">33</td> <td align="center" valign="bottom">47</td> <td align="center" valign="bottom">33</td> </tr> <tr ID="ID_2441653A-D91A-4543-80D7-1EBDA652F65E"> <td align="left" valign="bottom">Anorexia</td> <td align="center" valign="bottom">27</td> <td align="center" valign="bottom">16</td> <td align="center" valign="bottom">25</td> <td align="center" valign="bottom">19</td> <td align="center" valign="bottom">21</td> <td align="center" valign="bottom">14</td> </tr> <tr ID="ID_C45A38EB-092B-42F7-B224-5D499755BEB7"> <td align="left" valign="bottom">Dyspepsia</td> <td align="center" valign="bottom">14</td> <td align="center" valign="bottom"> 6</td> <td align="center" valign="bottom">16</td> <td align="center" valign="bottom"> 9</td> <td align="center" valign="bottom">16</td> <td align="center" valign="bottom"> 9</td> </tr> <tr ID="ID_CB2A91F1-17C9-4D2A-B0D1-25616A30A012"> <td align="left" styleCode="Botrule" valign="bottom">Vomiting</td> <td align="center" styleCode="Botrule" valign="bottom">11</td> <td align="center" styleCode="Botrule" valign="bottom">10</td> <td align="center" styleCode="Botrule" valign="bottom"> 9</td> <td align="center" styleCode="Botrule" valign="bottom">13</td> <td align="center" styleCode="Botrule" valign="bottom">12</td> <td align="center" styleCode="Botrule" valign="bottom"> 8</td> </tr> </tbody> </table>

<table ID="ID_0807E463-3F96-4448-8D95-8FEC39762AAE" border="single" frame="box" width="623.000"> <caption ID="ID_D1777659-10CA-444A-A813-9F9F65156E6F">TABLE 4. Selected Treatment-Emergent Adverse Events: Previously Untreated and Relapse Adult Patients (continued)</caption> <col width="30.7%"/> <col width="11.6%"/> <col width="11.6%"/> <col width="11.6%"/> <col width="11.6%"/> <col width="11.6%"/> <col width="11.6%"/> <tbody> <tr ID="ID_0CD4F6F2-B248-47BF-A8C8-74C4C3610C90"> <td align="left" styleCode="Toprule" valign="bottom"/> <td align="center" colspan="6" styleCode="Toprule" valign="bottom"> <content styleCode="bold">Percentage of Patients</content> </td> </tr> <tr ID="ID_277AF689-D75B-4AEB-904B-770DDD4E827F"> <td align="left" valign="bottom"/> <td align="center" colspan="4" valign="bottom"> <content styleCode="bold">US Previously Untreated Study</content> </td> <td align="center" colspan="2" valign="bottom"> <content styleCode="bold">US Relapse Study</content> </td> </tr> <tr ID="ID_B15C5A35-0099-404A-AF6D-ED0E84F172F4"> <td align="left" valign="bottom"/> <td align="center" colspan="2" valign="bottom"> <content styleCode="bold">24 weeks of treatment</content> </td> <td align="center" colspan="2" valign="bottom"> <content styleCode="bold">48 weeks of treatment</content> </td> <td align="center" colspan="2" valign="bottom"> <content styleCode="bold">24 weeks of treatment</content> </td> </tr> <tr ID="ID_0E6E9FD6-4FC8-4033-BE17-12DC16987F57"> <td align="left" valign="bottom"> <paragraph> <content styleCode="bold">Patients Reporting</content> </paragraph> <content styleCode="bold">Adverse Events<footnote ID="ID-DC7C772E-3411-4BFE-9B92-C7DDE235E60B">Patients reporting one or more adverse events. A patient may have reported more than one adverse event within a body system/organ class category.</footnote> </content> </td> <td align="center" valign="bottom"> <paragraph> <content styleCode="bold">INTRON A</content> </paragraph> <paragraph> <content styleCode="bold">plus</content> </paragraph> <paragraph> <content styleCode="bold">Ribavirin</content> </paragraph> <content styleCode="bold">(N=228)</content> </td> <td align="center" valign="bottom"> <paragraph> <content styleCode="bold">INTRON A</content> </paragraph> <paragraph> <content styleCode="bold">plus</content> </paragraph> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <content styleCode="bold">(N=231)</content> </td> <td align="center" valign="bottom"> <paragraph> <content styleCode="bold">INTRON A</content> </paragraph> <paragraph> <content styleCode="bold">plus</content> </paragraph> <paragraph> <content styleCode="bold">Ribavirin</content> </paragraph> <content styleCode="bold">(N=228)</content> </td> <td align="center" valign="bottom"> <paragraph> <content styleCode="bold">INTRON A</content> </paragraph> <paragraph> <content styleCode="bold">plus</content> </paragraph> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <content styleCode="bold">(N=225)</content> </td> <td align="center" valign="bottom"> <paragraph> <content styleCode="bold">INTRON A</content> </paragraph> <paragraph> <content styleCode="bold">plus</content> </paragraph> <paragraph> <content styleCode="bold">Ribavirin</content> </paragraph> <content styleCode="bold">(N=77)</content> </td> <td align="center" valign="bottom"> <paragraph> <content styleCode="bold">INTRON A</content> </paragraph> <paragraph> <content styleCode="bold">plus</content> </paragraph> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <content styleCode="bold">(N=76)</content> </td> </tr> <tr ID="ID_2B0AE038-5D0D-4FA0-B575-D87BCAEBE6F8"> <td align="left" valign="bottom"> <content styleCode="bold">Musculoskeletal System Disorders</content> </td> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> </tr> <tr ID="ID_CC14A6D3-51A5-42CF-BA9D-9CFF43273DD0"> <td align="left" valign="bottom">Myalgia</td> <td align="center" valign="bottom">61</td> <td align="center" valign="bottom">57</td> <td align="center" valign="bottom">64</td> <td align="center" valign="bottom">63</td> <td align="center" valign="bottom">61</td> <td align="center" valign="bottom">58</td> </tr> <tr ID="ID_EAB60A6F-AD1D-4170-8C8B-0E0D17F0CD96"> <td align="left" valign="bottom">Arthralgia</td> <td align="center" valign="bottom">30</td> <td align="center" valign="bottom">27</td> <td align="center" valign="bottom">33</td> <td align="center" valign="bottom">36</td> <td align="center" valign="bottom">29</td> <td align="center" valign="bottom">29</td> </tr> <tr ID="ID_705A3405-003F-454F-A4C0-D135ECCB93D1"> <td align="left" valign="bottom">Musculoskeletal pain</td> <td align="center" valign="bottom">20</td> <td align="center" valign="bottom">26</td> <td align="center" valign="bottom">28</td> <td align="center" valign="bottom">32</td> <td align="center" valign="bottom">22</td> <td align="center" valign="bottom">28</td> </tr> <tr ID="ID_3537C37B-FAE1-403F-97B0-7C09F51261FB"> <td align="left" valign="bottom"> <content styleCode="bold">Psychiatric Disorders</content> </td> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> </tr> <tr ID="ID_2C3EA576-C965-4DDC-AB89-B9FADCF59993"> <td align="left" valign="bottom">Insomnia</td> <td align="center" valign="bottom">39</td> <td align="center" valign="bottom">27</td> <td align="center" valign="bottom">39</td> <td align="center" valign="bottom">30</td> <td align="center" valign="bottom">26</td> <td align="center" valign="bottom">25</td> </tr> <tr ID="ID_0FFF089D-8861-4D9F-A7A9-A1C21AEA1C71"> <td align="left" valign="bottom">Irritability</td> <td align="center" valign="bottom">23</td> <td align="center" valign="bottom">19</td> <td align="center" valign="bottom">32</td> <td align="center" valign="bottom">27</td> <td align="center" valign="bottom">25</td> <td align="center" valign="bottom">20</td> </tr> <tr ID="ID_3E3A187F-91A3-40B3-A863-A0A45C768BE2"> <td align="left" valign="bottom">Depression</td> <td align="center" valign="bottom">32</td> <td align="center" valign="bottom">25</td> <td align="center" valign="bottom">36</td> <td align="center" valign="bottom">37</td> <td align="center" valign="bottom">23</td> <td align="center" valign="bottom">14</td> </tr> <tr ID="ID_A9CA51F8-19A3-46D4-9B09-D79512557419"> <td align="left" valign="bottom">Emotional lability</td> <td align="center" valign="bottom"> 7</td> <td align="center" valign="bottom"> 6</td> <td align="center" valign="bottom">11</td> <td align="center" valign="bottom"> 8</td> <td align="center" valign="bottom">12</td> <td align="center" valign="bottom"> 8</td> </tr> <tr ID="ID_C53EF7A2-CD34-45F3-8FBC-2CD212AE27C2"> <td align="left" valign="bottom">Concentration impaired</td> <td align="center" valign="bottom">11</td> <td align="center" valign="bottom">14</td> <td align="center" valign="bottom">14</td> <td align="center" valign="bottom">14</td> <td align="center" valign="bottom">10</td> <td align="center" valign="bottom">12</td> </tr> <tr ID="ID_B7E72F82-1AAD-4CA2-9A23-D590A45B050C"> <td align="left" valign="bottom">Nervousness</td> <td align="center" valign="bottom"> 4</td> <td align="center" valign="bottom"> 2</td> <td align="center" valign="bottom"> 4</td> <td align="center" valign="bottom"> 4</td> <td align="center" valign="bottom"> 5</td> <td align="center" valign="bottom"> 4</td> </tr> <tr ID="ID_643527FC-2CBA-4E2D-82A4-0644C2392E3A"> <td align="left" valign="bottom"> <content styleCode="bold">Respiratory System Disorders</content> </td> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> </tr> <tr ID="ID_F0A5BFBC-FDD6-49F3-AF14-26C4EBE0BC09"> <td align="left" valign="bottom">Dyspnea</td> <td align="center" valign="bottom">19</td> <td align="center" valign="bottom"> 9</td> <td align="center" valign="bottom">18</td> <td align="center" valign="bottom">10</td> <td align="center" valign="bottom">17</td> <td align="center" valign="bottom">12</td> </tr> <tr ID="ID_A44CA4D2-7FCB-41EC-A575-BBF4C3503414"> <td align="left" valign="bottom">Sinusitis</td> <td align="center" valign="bottom"> 9</td> <td align="center" valign="bottom"> 7</td> <td align="center" valign="bottom">10</td> <td align="center" valign="bottom">14</td> <td align="center" valign="bottom">12</td> <td align="center" valign="bottom"> 7</td> </tr> <tr ID="ID_10149AD1-409F-426C-8156-226056047705"> <td align="left" valign="bottom"> <content styleCode="bold">Skin and Appendages Disorders</content> </td> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> </tr> <tr ID="ID_F1D90F5B-F034-457A-A17D-3F62650EABF8"> <td align="left" valign="bottom">Alopecia</td> <td align="center" valign="bottom">28</td> <td align="center" valign="bottom">27</td> <td align="center" valign="bottom">32</td> <td align="center" valign="bottom">28</td> <td align="center" valign="bottom">27</td> <td align="center" valign="bottom">26</td> </tr> <tr ID="ID_A8B6BDD9-A246-42E2-BD79-ACD658C889B8"> <td align="left" valign="bottom">Rash</td> <td align="center" valign="bottom">20</td> <td align="center" valign="bottom"> 9</td> <td align="center" valign="bottom">28</td> <td align="center" valign="bottom"> 8</td> <td align="center" valign="bottom">21</td> <td align="center" valign="bottom"> 5</td> </tr> <tr ID="ID_DB8310DD-8855-4E4B-9E28-5F3FFE09734A"> <td align="left" valign="bottom">Pruritus</td> <td align="center" valign="bottom">21</td> <td align="center" valign="bottom"> 9</td> <td align="center" valign="bottom">19</td> <td align="center" valign="bottom"> 8</td> <td align="center" valign="bottom">13</td> <td align="center" valign="bottom"> 4</td> </tr> <tr ID="ID_ABFA5490-BC42-48AB-891E-25CF6943C113"> <td align="left" valign="bottom"> <content styleCode="bold">Special Senses, Other Disorders</content> </td> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> <td align="center" valign="bottom"/> </tr> <tr ID="ID_B6457E7B-E31F-4E30-B73A-6DD0BFD04601"> <td align="left" styleCode="Botrule" valign="bottom">Taste perversion</td> <td align="center" styleCode="Botrule" valign="bottom"> 7</td> <td align="center" styleCode="Botrule" valign="bottom"> 4</td> <td align="center" styleCode="Botrule" valign="bottom"> 8</td> <td align="center" styleCode="Botrule" valign="bottom"> 4</td> <td align="center" styleCode="Botrule" valign="bottom"> 6</td> <td align="center" styleCode="Botrule" valign="bottom"> 5</td> </tr> </tbody> </table>