Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| T20-310 | |||
| 295E |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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| Name | Class |
|---|---|
| Trimeris | INDUSTRY |
This study will evaluate T-20 in children.
Children are stratified by age group (3 through 11 years and 12 through 16 years). Samples for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the selection of concomitant antiretrovirals. Simultaneous to initiating T-20, all patients begin a "new" optimized antiretroviral regimen based on the patients' prior treatment history, historical resistance testing results, and the results of the testing performed at screening. Patients are followed for safety and other assessments at Weeks 1, 2, and 4, then monthly through Week 24 and bimonthly through Week 48. Pharmacokinetic sampling at selected study visits are performed.
Not provided
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enfuvirtide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343) | The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods. | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343) | The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods. | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) |
Not provided
Inclusion Criteria
Patients may be eligible for this study if they:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hosp Los Angeles | Los Angeles | California | 90027 | United States | ||
| Univ of Florida Gainesville |
Not provided
Overall, 52 participants were enrolled in this study conducted at 16 centers in Spain and United States between 23 August 2001 and 09 December 2004.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stratum A | Participants of age greater than or equal to (>=) 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant's participation, whichever came first. |
| FG001 | Stratum B | Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant's participation, whichever came first. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Stratum A | Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant's participation, whichever came first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343) | The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods. | Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population. | Posted | Mean | Standard Deviation | microgram hour per milliliter (mcg.h/mL) | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) |
|
Up to Week 96
All participants who received at least one dose of study medication were included in safety analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enfuvirtide | Participants in stratum A (age >= 3 years and less than 12 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose) and in stratum B (age >= 12 years and less than 17 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia nos | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection nos | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077560 | Enfuvirtide |
| ID | Term |
|---|---|
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015700 | HIV Envelope Protein gp41 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide | Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) |
| Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343) | Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered. | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) |
| AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800) | The ratio of the area under plasma concentration-time curve from time 0 to 12 hours of Enfuvirtide Metabolite (Ro 50-6343) versus enfuvirtide was calculated. | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) |
| Number of Participants With Adverse Events (AEs) and Serious AEs | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. | Up to Week 4 after discontinuation of therapy |
| Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities | Pediatric AIDS Clinical Trials Group (PACTG) toxicity grading scale was used for reviewing and grading clinically significant laboratory abnormalities. PACTG Grade 3 and Grade 4 were considered Severe and life threatening, respectively. | Up to Week 96 |
| Number of Participants Who Died | Up to Week 96 |
| Number of Participants Who Prematurely Withdrew Due to AE | Up to Week 96 |
| Number of Participants With Worst Local Injection Site Reactions | Numbers of Participants With worst local injection site reactions were reported. Localized injection site reactions like erythema, induration, pruritus, nodule and cyst, and ecchymosis were recorded. | Up to Week 96 |
| Gainesville |
| Florida |
| 32610 |
| United States |
| New York Hosp - Cornell / Program for Children with AIDS | New York | New York | 10021 | United States |
| Mount Sinai Hosp | New York | New York | 10029 | United States |
| Bronx Lebanon Hosp Ctr | The Bronx | New York | 10457 | United States |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | The Bronx | New York | 10461 | United States |
| Children's Hosp of the King's Daughters | Norfolk | Virginia | 23507 | United States |
| Death |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Insufficient Therapy |
|
| Admin |
|
| BG001 | Stratum B | Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant's participation, whichever came first. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Stratum B | Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant's participation, whichever came first. |
|
|
| Secondary | Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343) | The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods. | Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) |
|
|
|
| Secondary | Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide | Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population. | Posted | Mean | Standard Deviation | hour | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) |
|
|
|
| Secondary | Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343) | Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered. | Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) |
|
|
|
| Secondary | AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800) | The ratio of the area under plasma concentration-time curve from time 0 to 12 hours of Enfuvirtide Metabolite (Ro 50-6343) versus enfuvirtide was calculated. | Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population. | Posted | Mean | Standard Deviation | Ratio | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) and Serious AEs | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. | Safety Analysis Population: All participants who received at least one dose of study medication were included. | Posted | Number | participants | Up to Week 4 after discontinuation of therapy |
|
|
|
| Secondary | Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities | Pediatric AIDS Clinical Trials Group (PACTG) toxicity grading scale was used for reviewing and grading clinically significant laboratory abnormalities. PACTG Grade 3 and Grade 4 were considered Severe and life threatening, respectively. | Safety Analysis Population: All participants who received at least one dose of study medication were included. | Posted | Number | participants | Up to Week 96 |
|
|
|
| Secondary | Number of Participants Who Died | Safety Analysis Population: All participants who received at least one dose of study medication were included. | Posted | Number | participants | Up to Week 96 |
|
|
|
| Secondary | Number of Participants Who Prematurely Withdrew Due to AE | Safety Analysis Population: All participants who received at least one dose of study medication were included. | Posted | Number | participants | Up to Week 96 |
|
|
|
| Secondary | Number of Participants With Worst Local Injection Site Reactions | Numbers of Participants With worst local injection site reactions were reported. Localized injection site reactions like erythema, induration, pruritus, nodule and cyst, and ecchymosis were recorded. | Safety Analysis Population: All participants who received at least one dose of study medication were included. | Posted | Number | participants | Up to Week 96 |
|
|
|
| 31 |
| 52 |
| 52 |
| 52 |
| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis nos | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis nos | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Colitis pseudomembranous | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis viral nos | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Kawasaki's disease | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Lobar pneumonia nos | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonia viral nos | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Sinusitis nos | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Staphylococcal abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site abscess | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Metabolic disorder nos | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tetany | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sweat gland tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Dystonia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Otitis media nos | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Sinusitis nos | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Impetigo nos | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Viral infection nos | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis nos | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bronchospasm nos | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rhinitis allergic nos | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthma nos | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting nos | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea nos | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain nos | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Loose stools | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sore throat nos | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dermatitis Nos | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Acne Nos | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Eczema Seborrhoeic | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Conjunctivitis nec | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Haematuria present | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache Nos | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypersensitivity Nos | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Earache | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Appetite decreased nos | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014760 | Viral Fusion Proteins |
| D050576 | Membrane Fusion Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D015488 | HIV Antigens |
| D000956 | Antigens, Viral |
| D014764 | Viral Proteins |
| D054299 | env Gene Products, Human Immunodeficiency Virus |
| D015686 | Gene Products, env |
| D012191 | Retroviridae Proteins |
| D054298 | Human Immunodeficiency Virus Proteins |
| D014759 | Viral Envelope Proteins |
| D015678 | Viral Structural Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
| Neutrophils Grade 3 |
|
| Neutrophils Grade 4 |
|
| ASAT Grade 3 |
|
| ASAT Grade 4 |
|
| ALAT Grade 3 |
|
| ALAT Grade 4 |
|
| Total Bilirubin Grade 3 |
|
| Total Bilirubin Grade 4 |
|
| GGT Grade 3 |
|
| GGT Grade 4 |
|
| Amylase Grade 3 |
|
| Amylase Grade 4 |
|
| Induration |
|
| Pruritus |
|
| Ecchymosis |
|
| Others |
|