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| Name | Class |
|---|---|
| Clalit Health Services | OTHER |
This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Viral Response (SVR) at Week 24 | The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of SVR at Week 24 | SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype. | Week 24 |
| Number of Participants With SVR at Week 24 According to the Demographic Characteristics |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Chronic hepatitis C patients initiating Pegasys-based treatment
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haemek Hospital; Gastroenterology | Afula | 18101 | Israel | |||
| Barzilai MC; Gastroenterology |
The study was consisted of 3 arms of treatments: 1. Dual therapy: Peginterferon alfa-2a & Ribavirin; 2. Triple therapy :Peginterferon alfa 2a & Ribavirin & Telaprevir; 3. Triple therapy: Peginterferon alfa 2a & Ribavirin & Boceprevir
The study was conducted at 21 investigational centers in Israel.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alfa-2a + Ribavirin | Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information. |
| FG001 | Peginterferon Alfa-2a + Ribavirin + Telaprevir |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants.
| Week 24 |
| Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | RVR was defined as HCV-RNA <50 IU/mL by Week 4 | Week 4 |
| Percentage of Participants With Extended RVR | Extended RVR was defined as HCV-RNA <50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 & 24 for participants treated with boceprevir. The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'. | Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group |
| Percentage of Participants With Complete Early Virologic Response (cEVR) | Complete early virologic response (cEVR) was defined as HCV-RNA <50 IU/mL by Week 12 | Week 12 |
| Percentage of Participants With End of Treatment Response (EoT) | End-of-Treatment (EoT) response was defined as HCV-RNA <50 IU/mL by the end of treatment. | Week 24 |
| Percentage of Participants With Virologic Relapse | Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA <50 IU/mL at EoT. | Week 72 |
| Treatment Duration | The average amount of time a treatment was prescribed to participants. | Week 48 |
| Time to First Dose Modification of Peginterferon Alfa-2a | Week 48 |
| Time to First Dose Modification of Ribavirin | Week 48 |
| Time to First Dose Modification of Telaprevir/Boceprevir | Week 48 |
| Percentage of Participants With Adverse Events (AEs) | 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. Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants. | Week 48 |
| Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia | Week 48 |
| Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia | Week 48 |
| Percentage of Participants Who Had SVR at Week 24 With Dose Modifications | Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study. | Week 24 |
| Ashkelon |
| 78278 |
| Israel |
| Soroka Medical Center; Gastroenterology | Beersheba | 84105 | Israel |
| Hillel Yaffe Hospital; Gastroenterology | Hadera | 38100 | Israel |
| Rambam Medical Center; Gastroenterology - Liver Unit | Haifa | 31096 | Israel |
| Bnei-Zion Medical Center; Gastroenterology | Haifa | 33394 | Israel |
| Carmel Hospital; Liver Unit | Haifa | 34362 | Israel |
| Wolfson Hospital; Gastroenterology Unit | Holon | 58100 | Israel |
| Shaare Zedek Hospital Liver Unit; Liver Unit | Jerusalem | 91031 | Israel |
| Hadassah Hospital; Liver Unit | Jerusalem | 91120 | Israel |
| Meir Medical Center; Liver Unit | Kfar Saba | 44281 | Israel |
| Western Galilee Hospital - Nahariya | Nahariya | 22100 | Israel |
| Holy Family Medical Center; Liver Unit | Nazareth | Israel |
| Beilinson-Rabin Liver Unit; Liver Unit | Petah Tikva | Israel |
| Hasharon Mc; Gastroenterology | Petah Tikva | Israel |
| Sheba Medical Center; Tel Hashomer | Ramat Gan | 5262100 | Israel |
| Kaplan Medical Center; Gastroenterology Unit | Rehovot | 76100 | Israel |
| Rebecca Sieff Medical Center; Liver Unit | Safed | 13110 | Israel |
| Tel-Aviv Sourasky Medical Center; Liver Unit | Tel Aviv | 6423906 | Israel |
| Poria Hospital; Gastroenterology | Tiberias | Israel |
| Assaf Harofeh; Gastroenterology | Ẕerifin | 6093000 | Israel |
Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Teleprevir) were at the discretion of the Investigator in accordance with the current local prescribing information. |
| FG002 | Peginterferon Alfa-2a + Ribavirin + Boceprevir | Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information. |
| FG003 | No Information on Treatment Allocation | Participants for which Treatment Allocation Data is Unavailable. |
| COMPLETED |
|
| NOT COMPLETED |
|
All Enrolled Participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon Alfa-2a + Ribavirin | Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information. |
| BG001 | Peginterferon Alfa-2a + Ribavirin + Telaprevir | Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Teleprevir) were at the discretion of the Investigator in accordance with the current local prescribing information. |
| BG002 | Peginterferon Alfa-2a + Ribavirin + Boceprevir | Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information. |
| BG003 | No Information on Treatment Allocation | Participants for which Treatment Allocation Data is Unavailable |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
|
| 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 Sustained Viral Response (SVR) at Week 24 | The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. | Modified All Treated (mTRT) Population: includes all participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; the participants' treatment documentation was sufficient for assignment to treatment groups. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 24 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Comparison of SVR at Week 24 | SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype. | Modified All Treated (mTRT) Population: includes all participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; the participants' treatment documentation was sufficient for assignment to treatment groups. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With SVR at Week 24 According to the Demographic Characteristics | The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants. | Participants who treated for chronic hepatitis C(CHC)with either dual therapy (peginterferon alfa-2a and ribavirin)or triple therapy(peginterferon alfa-2a and ribavirin and telaprevir/boceprevir)for up to 24 weeks thereafter in line with local prescribing information at time of study and for whom demographic baseline characteristics were available. | Posted | Count of Participants | Participants | Week 24 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | RVR was defined as HCV-RNA <50 IU/mL by Week 4 | mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 4 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Extended RVR | Extended RVR was defined as HCV-RNA <50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 & 24 for participants treated with boceprevir. The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'. | mTRT population:participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy;had received one of study's triple combination therapies;participants' treatment documentation was sufficient for assignment to treatment groups.Number of participants analyzed:participants evaluated for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Early Virologic Response (cEVR) | Complete early virologic response (cEVR) was defined as HCV-RNA <50 IU/mL by Week 12 | mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 12 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With End of Treatment Response (EoT) | End-of-Treatment (EoT) response was defined as HCV-RNA <50 IU/mL by the end of treatment. | mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Relapse | Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA <50 IU/mL at EoT. | mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 72 |
| |||||||||||||||||||||||||||||||||
| Secondary | Treatment Duration | The average amount of time a treatment was prescribed to participants. | All Enrolled Participants | Posted | Mean | Standard Deviation | Weeks | Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to First Dose Modification of Peginterferon Alfa-2a | mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Days | Week 48 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to First Dose Modification of Ribavirin | mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Days | Week 48 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to First Dose Modification of Telaprevir/Boceprevir | mTRT population:participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy;had received 1 of study's triple combination therapies;participants' treatment documentation was sufficient for assignment to treatment groups.Number of participants analyzed:participants evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Days | Week 48 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | 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. Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants. | Safety Population. Included only participants who had received at least one dose of peginterferon alfa-2a plus ribavirin or peginterferon alfa-2a plus ribavirin plus telaprevir/boceprevir and had at least one post-baseline safety assessment. | Posted | Number | Percentage of Participants | Week 48 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia | Safety Population. Included only participants who had received at least one dose of peginterferon alfa-2a plus ribavirin or peginterferon alfa-2a plus ribavirin plus telaprevir/boceprevir and had at least one post-baseline safety assessment. | Posted | Mean | Standard Deviation | Grams per Deciliter (g/dl) | Week 48 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia | Safety Population. Included only participants who had received at least one dose of peginterferon alfa-2a plus ribavirin or peginterferon alfa-2a plus ribavirin plus telaprevir/boceprevir and had at least one post-baseline safety assessment. | Posted | Number | Percentage of Participants | Week 48 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Had SVR at Week 24 With Dose Modifications | Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study. | mTRT population: includes all participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; the participants' treatment documentation was sufficient for assignment to treatment groups. | Posted | Number | percentage of participants | Week 24 |
|
|
Week 48
The Safety Analysis population was defined to include only participants who had received at least one dose of a peginterferon alfa-2a plus ribavirin, or a peginterferon alfa-2a plus ribavirin plus telaprevir/boceprevir and had at least one post-baseline safety assessment. Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants.
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 | Peginterferon Alfa-2a + Ribavirin | Dual Therapy. Dosing and treatment duration of the dual therapy (Peginterferon Alfa-2a + Ribavirin) were at the discretion of the Investigator in accordance with the current local prescribing information. | 24 | 311 | 208 | 311 | ||
| EG001 | Peginterferon Alfa-2a + Ribavirin +Telaprevir | Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Teleprevir) were at the discretion of the Investigator in accordance with the current local prescribing information. | 78 | 445 | 338 | 445 | ||
| EG002 | Peginterferon Alfa-2a + Ribavirin + Boceprevir | Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin +Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information. | 26 | 192 | 161 | 192 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemolytic Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hearing Impaired | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diabetes Mellitus | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal Perforation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Face Oedema | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Multi-Organ Failure | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Biliary Colic | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cryptococcal Fungaemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Diabetic Foot Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Salmonella Bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gout | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Adenocarcinoma Pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
| |
| Anxiety Disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Calculus Urethal | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal Colic | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Testicular Pain | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diabetic Foot | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Folliculitis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal Stone Removal | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
| |
| Vena Cava Filter Removal | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Anorectal Discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Pallor | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Weight Decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Depressed Mood | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Sleep Disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | Genentech@druginfo.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
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| Unknown |
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Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information.
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| Peginterferon Alfa-2a + Ribavirin + Boceprevir |
Triple Therapy. Dosing and treatment duration of the triple therapy (Peginterferon Alfa-2a + Ribavirin + Boceprevir) were at the discretion of the Investigator in accordance with the current local prescribing information. |
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