Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week | Placebo Comparator | Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. |
|
| Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week | Experimental | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. |
|
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week | Experimental | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. |
|
| Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribavirin | Drug | tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). | 24 weeks after the completion of study drug dosing (up to Week 72) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). | 12 weeks after the completion of study drug dosing (up to Week 60) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Call For Information | Call For Information | Austria | ||||
| Call For Information |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19403903 | Derived | Hezode C, Forestier N, Dusheiko G, Ferenci P, Pol S, Goeser T, Bronowicki JP, Bourliere M, Gharakhanian S, Bengtsson L, McNair L, George S, Kieffer T, Kwong A, Kauffman RS, Alam J, Pawlotsky JM, Zeuzem S; PROVE2 Study Team. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med. 2009 Apr 30;360(18):1839-50. doi: 10.1056/NEJMoa0807650. |
Not provided
Not provided
A total of 334 subjects were enrolled, of which 11 subjects discontinued the study prior to study drug administration. A total of 323 subjects started treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week | Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. |
| FG001 | Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. |
| FG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. |
| FG003 | Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week | Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). | The Full Analysis set included all randomized subjects who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | 24 weeks after the completion of study drug dosing (up to Week 72) |
|
Adverse Events during Baseline through Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
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 | PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week | Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ASTHENIA | General disorders | MedDRA 9.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Chodakewitz, M.D. | Vertex Pharmaceuticals Incorporated | 617-341-6777 | Jeff_Chodakewitz@vrtx.com |
Not provided
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| C486464 | telaprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks. |
|
| Pegylated Interferon Alfa 2a | Drug | Solution for injection |
|
| Placebo | Drug | tablet |
|
| Telaprevir | Drug | tablet |
|
|
| Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing |
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). |
| Completion of study drug dosing (up to Week 48) |
| Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study. | Baseline up to Week 48 |
| Number of Subjects With Viral Relapse | Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). | After last dose of study drug up to antiviral follow-up (up to Week 72) |
| Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir | Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported. | Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85 |
| Call For Information |
| France |
| Call For Information | Call For Information | Germany |
| Call for Information | Call For Information | United Kingdom |
| Noncompliance |
|
| Physician Decision |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Refusal of Treatment |
|
| No Response |
|
| Ineligibility due to Exclusion Criterion |
|
| Virologic Stopping Rule |
|
| BG001 | Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. |
| BG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. |
| BG003 | Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. |
| OG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. |
| OG003 | Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks. |
|
|
|
| Secondary | Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). | The Full Analysis set included all randomized subjects who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the completion of study drug dosing (up to Week 60) |
|
|
|
|
| Secondary | Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). | The Full Analysis set included all randomized subjects who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Completion of study drug dosing (up to Week 48) |
|
|
|
| Secondary | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study. | The Full Analysis set included all randomized subjects who received at least 1 dose of study drug. | Posted | Number | participants | Baseline up to Week 48 |
|
|
|
| Secondary | Number of Subjects With Viral Relapse | Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). | Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48). | Posted | Number | participants | After last dose of study drug up to antiviral follow-up (up to Week 72) |
|
|
|
| Secondary | Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir | Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported. | Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85 |
|
|
|
| 8 |
| 82 |
| 81 |
| 82 |
| EG001 | Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. | 16 | 81 | 80 | 81 |
| EG002 | Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. | 11 | 82 | 82 | 82 |
| EG003 | Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks. | 9 | 78 | 78 | 78 |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| TOXIC SKIN ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| DISORIENTATION | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| EMOTIONAL DISTRESS | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| PARANOIA | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| ALCOHOLIC PANCREATITIS | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| BACTERIAL SEPSIS | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| PNEUMONIA HERPES VIRAL | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| SPEECH DISORDER | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| CATHETER RELATED COMPLICATION | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| TESTICULAR SWELLING | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
|
| UTERINE POLYP | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| HYDROCELE | Congenital, familial and genetic disorders | MedDRA 9.0 | Systematic Assessment |
|
| HYPERTHYROIDISM | Endocrine disorders | MedDRA 9.0 | Systematic Assessment |
|
| RETINAL HAEMORRHAGE | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| SPLENECTOMY | Surgical and medical procedures | MedDRA 9.0 | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| IRRITABILITY | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| INJECTION SITE ERYTHEMA | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| ANAL PRURITUS | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| ANORECTAL DISCOMFORT | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| LETHARGY | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| NERVOUSNESS | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| DRY EYE | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA 9.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
Not provided
| 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 |
| Odds Ratio (OR) |
| 1.623 |
| 2-Sided |
| 95 |
| 0.864 |
| 3.050 |
| No |
| Superiority or Other |
| Regression, Logistic | 0.1099 | Odds Ratio (OR) | 0.591 | 2-Sided | 95 | 0.311 | 1.126 | No | Superiority or Other |
| SAEs |
|
| Title | Measurements |
|---|---|
|