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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003455-21 | EudraCT Number |
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The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy.
Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL/VOX (Primary Study) | Experimental | SOF/VEL/VOX for 12 weeks |
|
| Placebo (Primary Study) | Experimental | Placebo to match SOF/VEL/VOX for 12 weeks |
|
| SOF/VEL/VOX (Deferred Treatment Substudy) | Experimental | SOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL/VOX | Drug | 400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study) | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study) | SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment, respectively. | Posttreatment Week 4 |
| Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study) |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bourlière M, Gordon SC, Ramji A, Ravendhran N, Tran TT, Hyland RH, et al. Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks as a Salvage Regimen in NS5A Inhibitor-Experienced Patients with Genotype 1-6 Infection: The Phase 3 POLARIS-1 Study [Abstract 194]. J Hepatology 2016;63 (1S):102A. | ||
| 29155352 | Background | Younossi ZM, Stepanova M, Gordon S, Zeuzem S, Mann MP, Jacobson I, Bourliere M, Cooper C, Flamm S, Reddy KR, Kowdley K, Younossi I, Hunt S. Patient-Reported Outcomes Following Treatment of Chronic Hepatitis C Virus Infection With Sofosbuvir and Velpatasvir, With or Without Voxilaprevir. Clin Gastroenterol Hepatol. 2018 Apr;16(4):567-574.e6. doi: 10.1016/j.cgh.2017.11.023. Epub 2017 Nov 16. | |
| 29859740 |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.
18 months after study completion
A secured external environment with username, password, and RSA code.
520 participants were screened.
Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 11 November 2015. The last study visit occurred on 21 June 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL/VOX (Primary Study) | Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet orally once daily with food for 12 weeks |
| FG001 | Placebo (Primary Study) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Primary Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Tablet administered orally once daily with food |
|
| Weeks 1, 2, 4, 8 and 12 |
| Change From Baseline in HCV RNA (Primary Study) | Baseline; Weeks 1, 2, 4, 8 and 12 |
| Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study) | SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. | Posttreatment Week 24 |
| Percentage of Participants With Virologic Failure (Primary Study) | Virologic failure is defined as:
| Up to Posttreatment Week 24 |
| Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy) | SVR4, SVR12 and SVR24 was defined as HCV RNA < LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively. | Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy) |
| Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy) | Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy) |
| Change From Baseline in HCV RNA (Deferred Treatment Substudy) | Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy) |
| Percentage of Participants With Virologic Failure (Deferred Treatment Substudy) | Virologic failure is defined as:
| Up to Posttreatment Week 24 (Deferred Treatment Substudy) |
| Los Angeles |
| California |
| United States |
| Palo Alto | California | United States |
| Pasadena | California | United States |
| Rialto | California | United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Aurora | Colorado | United States |
| Englewood | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Gainesville | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Wellington | Florida | United States |
| Atlanta | Georgia | United States |
| Marietta | Georgia | United States |
| Chicago | Illinois | United States |
| Indianapolis | Indiana | United States |
| Baltimore | Maryland | United States |
| Catonsville | Maryland | United States |
| Boston | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Detroit | Michigan | United States |
| Kansas City | Missouri | United States |
| St Louis | Missouri | United States |
| Hillsborough | New Jersey | United States |
| New York | New York | United States |
| The Bronx | New York | United States |
| Asheville | North Carolina | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Providence | Rhode Island | United States |
| Germantown | Tennessee | United States |
| Knoxville | Tennessee | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Murray | Utah | United States |
| Falls Church | Virginia | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| Madison | Wisconsin | United States |
| Camperdown | New South Wales | Australia |
| Darlinghurst | New South Wales | Australia |
| Herston | Queensland | Australia |
| Clayton | Victoria | Australia |
| Fitzroy | Victoria | Australia |
| Melbourne | Victoria | Australia |
| Calgary | Alberta | Canada |
| Edmonton | Alberta | Canada |
| Vancouver | British Columbia | Canada |
| Brampton | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Clermont-Ferrand | France |
| Clichy | France |
| Créteil | France |
| Grenoble | France |
| Lille | France |
| Limoges | France |
| Lyon | France |
| Marseille | France |
| Montpellier | France |
| Nice | France |
| Paris | France |
| Pessac | France |
| Rennes | France |
| Rouen | France |
| Strasbourg | France |
| Toulouse | France |
| Vandœuvre-lès-Nancy | France |
| Villejuif | France |
| Berlin | Germany |
| Bonn | Germany |
| Cologne | Germany |
| Frankfurt am Main | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Christchurch | New Zealand |
| Grafton | New Zealand |
| San Juan | Puerto Rico |
| London | United Kingdom |
| Manchester | United Kingdom |
| Nottingham | United Kingdom |
| Portsmouth | United Kingdom |
| Background |
| Bourliere M, Gordon SC, Schiff ER, Tran TT, Ravendhran N, Landis CS, Hyland RH, Stamm LM, Zhang J, Dvory-Sobol H, Subramanian GM, Brainard DM, McHutchison JG, Serfaty L, Thompson AJ, Sepe TE, Curry MP, Reddy KR, Manns MP. Deferred treatment with sofosbuvir-velpatasvir-voxilaprevir for patients with chronic hepatitis C virus who were previously treated with an NS5A inhibitor: an open-label substudy of POLARIS-1. Lancet Gastroenterol Hepatol. 2018 Aug;3(8):559-565. doi: 10.1016/S2468-1253(18)30118-3. Epub 2018 May 31. |
| 28564569 | Result | Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Ledinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512. |
Placebo tablet orally once daily with food for 12 weeks
| FG002 | SOF/VEL/VOX (Deferred Treatment Substudy) | Participants who completed placebo treatment were eligible to enroll in to the open-label Deferred Treatment Substudy to receive SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Deferred Treatment Substudy |
|
|
Safety Analysis Set: all participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL/VOX (Primary Study) | SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks |
| BG001 | Placebo (Primary Study) | Placebo tablet orally once daily with food for 12 weeks |
| BG002 | 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: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| IL28b Status | The CC, CT, and TT alleles are different forms of the IL28b gene | Count of Participants | Participants |
| |||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | 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 Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. | Participants in the Full Analysis Set (all randomized/enrolled participants who took at least 1 dose of study drug) in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 12 visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 12 |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study) | Safety Analysis Set | Posted | Number | percentage of participants | Up to 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study) | SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment, respectively. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study) | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 1, 2, 4, 8 and 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA (Primary Study) | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Weeks 1, 2, 4, 8 and 12 |
|
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| Secondary | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study) | SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. | Participants in the Full Analysis Set in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 24 visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure (Primary Study) | Virologic failure is defined as:
| Participants in the Full Analysis Set in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 24 visit. | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
|
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| Secondary | Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy) | SVR4, SVR12 and SVR24 was defined as HCV RNA < LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy) | Full Analysis Set from the Deferred Treatment Sub study: all enrolled participants who took at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA (Deferred Treatment Substudy) | Participants with available data in the Full Analysis Set of the Deferred Treatment Substudy were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy) |
|
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| Secondary | Percentage of Participants With Virologic Failure (Deferred Treatment Substudy) | Virologic failure is defined as:
| Full Analysis Set in the Deferred Treatment Substudy | Posted | Number | percentage of participants | Up to Posttreatment Week 24 (Deferred Treatment Substudy) |
|
|
Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
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 | SOF/VEL/VOX (Primary Study) | SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks | 0 | 263 | 5 | 263 | 147 | 263 |
| EG001 | Placebo (Primary Study) | Placebo tablet orally once daily with food for 12 weeks | 0 | 152 | 7 | 152 | 80 | 152 |
| EG002 | SOF/VEL/VOX (Deferred Treatment Substudy) | Participants who completed placebo treatment were eligible for open-label Deferred Treatment Substudy. SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks | 0 | 147 | 6 | 147 | 87 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Scrotal infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Adrenal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Arteritis | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000654129 | sofosbuvir velpatasvir voxilaprevir drug combination |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Native Hawaiian or Pacific Islander |
|
| Not Disclosed |
|
| American Indian or Alaska Native |
|
| Other |
|
| Not Hispanic or Latino |
|
| Not Disclosed |
|
| Australia |
|
| Canada |
|
| France |
|
| Germany |
|
| New Zealand |
|
| United Kingdom |
|
| CT |
|
| TT |
|
| ≥ 800,000 IU/mL |
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 1 |
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| Week 2 |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Title | Denominators | Categories |
|---|
| Week 1 |
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| Week 2 |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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