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This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The anticipated time on study treatment is 3-12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avastin + Xeloda | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab [Avastin] | Drug | 7.5mg/kg iv on day 1 of each 3 week cycle. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response (OR) | Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. | Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Control | The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. SD was defined as not qualifying for PR or progressive disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melbourne | 3181 | Australia | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab/Capecitabine | A cycle was defined as the following: Participants received 7.5 milligrams per kilogram (mg/kg) bevacizumab intravenously (IV) on Day 1; and 1600 mg per square meter per day (mg/m^2/day) capecitabine tablets, orally (PO), in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab/Capecitabine | A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression. |
| 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 | Percentage of Participants With Objective Response (OR) | Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. | Per Protocol (PP) Population included participants who: received greater than or equal to (≥) 1 dose of study medication, ≥6 weeks of treatment (unless excluded for allowed reasons), did not severely violate inclusion/exclusion criteria, had tumor assessment, greater than (>) 50% of first 6 weeks of treatment, and were not replaced. | Posted | Number | 95% Confidence Interval | percentage of participants | Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up |
Adverse events were recorded from first intake of study medication until 28 days after the last intake of study medication with follow-up up until the event resolved or was adequately explained.
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab/Capecitabine | A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| capecitabine [Xeloda] |
| Drug |
1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle. |
|
| Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up |
| Time to Disease Progression - Percentage of Participants With an Event | Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment. | Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up |
| Time to Disease Progression | Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment. | Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up |
| Time to Disease Progression - Percentage of Participants Progression-free at 12 Months | Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment. | Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death. |
| Overall Survival - Percentage of Participants With an Event | Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. | Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death. |
| Overall Survival | Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. Median Overall Survival was estimated using the Kaplan-Meier method. | Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death. |
| Overall Survival - Percentage of Participants Event Free at 12 Months | Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. | Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death. |
| Hong Kong |
| Hong Kong |
| Singapore | 169610 | Singapore |
| Kueishan | 333 | Taiwan |
| Taipei | 00112 | Taiwan |
| Taipei | 106 | Taiwan |
| Taipei | 114 | Taiwan |
| Refused treatment |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Percentage of Participants With Disease Control | The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. SD was defined as not qualifying for PR or progressive disease. | PP population. | Posted | Number | 95% Confidence Interval | percentage of participants | Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up |
|
|
|
| Secondary | Time to Disease Progression - Percentage of Participants With an Event | Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment. | ITT population. | Posted | Number | percentage of participants | Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up |
|
|
|
| Secondary | Time to Disease Progression | Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment. | Intent-To-Treat (ITT) Population included all enrolled participants who received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up |
|
|
|
| Secondary | Time to Disease Progression - Percentage of Participants Progression-free at 12 Months | Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death. |
|
|
|
| Secondary | Overall Survival - Percentage of Participants With an Event | Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. | ITT population. | Posted | Number | percentage of participants | Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death. |
|
|
|
| Secondary | Overall Survival | Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. Median Overall Survival was estimated using the Kaplan-Meier method. | ITT Population. | Posted | Median | 95% Confidence Interval | months | Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death. |
|
|
|
| Secondary | Overall Survival - Percentage of Participants Event Free at 12 Months | Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death. |
|
|
|
| 15 |
| 45 |
| 44 |
| 45 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastric varices haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hepatitis fulminant | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal distention | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Bowel sounds abnormal | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastric varices haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pitting oedema | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Haemoglobin | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Prostate examination abnormal | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hepatitis fulminant | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (10.0) | Non-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 the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D008107 |
| Liver Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |