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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004792-39 | EudraCT Number |
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The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant recipients with hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
|
| Arm B | Experimental | Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
|
| Arm C | Experimental | Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks. |
|
| Arm D | Experimental | Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ombitasvir/paritaprevir/ritonavir and dasabuvir | Drug | Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | 12 weeks after the last actual dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24) | SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | 24 weeks after the last actual dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25386767 | Derived | Kwo PY, Mantry PS, Coakley E, Te HS, Vargas HE, Brown R Jr, Gordon F, Levitsky J, Terrault NA, Burton JR Jr, Xie W, Setze C, Badri P, Pilot-Matias T, Vilchez RA, Forns X. An interferon-free antiviral regimen for HCV after liver transplantation. N Engl J Med. 2014 Dec 18;371(25):2375-82. doi: 10.1056/NEJMoa1408921. Epub 2014 Nov 11. |
| Label | URL |
|---|---|
| Related Info | View source |
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This study included a 35-day screening period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| FG001 | Arm B | Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| FG002 | Arm C | Liver transplant receipts with HCV 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks. |
| FG003 | Arm D | Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| FG004 | Arm E | Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| FG005 | Arm F | Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| FG006 | Arm G | Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. |
| FG007 | Arm H | Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| FG008 | Arm I | Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. |
| FG009 | Arm J | Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| FG010 | Arm K | Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| BG001 |
| 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 Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days after the last dose of study drug. TEAEs and TESAEs were collected whether elicited or spontaneously reported by the participant.
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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 | ARM A | Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D006521 | Hepatitis, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C586094 | ombitasvir |
| C588260 | dasabuvir |
| C000607373 | Viekira Pak |
| C585405 | paritaprevir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| Arm E | Experimental | Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
|
| Arm F | Experimental | Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
|
| Arm G | Experimental | Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. |
|
| Arm H | Experimental | Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
|
| Arm I | Experimental | Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. |
|
| Arm J | Experimental | Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
|
| Arm K | Experimental | Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
|
|
| ombitasvir/paritaprevir/ritonavir | Drug | Tablet; ombitasvir coformulated with paritaprevir and ritonavir |
|
|
| ribavirin | Drug | tablet |
|
| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or confirmed HCV RNA ≥ LLOQ at any point during treatment after HCV RNA < LLOQ, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. | Up to 12 weeks (for 12-week treatment) or 24 weeks (for 24-week treatment) |
| Percentage of Participants With Post-treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. | From the end of treatment through 12 weeks after the last dose of study drug |
| Withdrew Consent |
|
| Arm B |
Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| BG002 | Arm C | Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks. |
| BG003 | Arm D | Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| BG004 | Arm E | Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| BG005 | Arm F | Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| BG006 | Arm G | Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. |
| BG007 | Arm H | Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| BG008 | Arm I | Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. |
| BG009 | Arm J | Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| BG010 | Arm K | Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| BG011 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| OG001 | Arm B | Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| OG002 | Arm C | Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks. |
| OG003 | Arm D | Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
| OG004 | Arm E | Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| OG005 | Arm F | Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| OG006 | Arm G | Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. |
| OG007 | Arm H | Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| OG008 | Arm I | Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. |
| OG009 | Arm J | Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| OG010 | Arm K | Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. |
|
|
| Secondary | Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24) | SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | All participants who received at least 1 dose of study drug (ITT population). | Posted | Number | 95% Confidence Interval | percentage of participants | 24 weeks after the last actual dose of study drug |
|
|
|
| Secondary | Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or confirmed HCV RNA ≥ LLOQ at any point during treatment after HCV RNA < LLOQ, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. | All participants who received at least 1 dose of study drug (ITT population). | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 weeks (for 12-week treatment) or 24 weeks (for 24-week treatment) |
|
|
|
| Secondary | Percentage of Participants With Post-treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. | All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA \ | Posted | Number | 95% Confidence Interval | percentage of participants | From the end of treatment through 12 weeks after the last dose of study drug |
|
|
|
| 0 |
| 34 |
| 2 |
| 34 |
| 33 |
| 34 |
| EG001 | ARM B | Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. | 0 | 27 | 1 | 27 | 27 | 27 |
| EG002 | ARM C | Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks. | 0 | 13 | 0 | 13 | 12 | 13 |
| EG003 | ARM D | Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG004 | ARM E | Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG005 | ARM F | Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. | 0 | 22 | 2 | 22 | 22 | 22 |
| EG006 | ARM G | Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. | 0 | 12 | 1 | 12 | 12 | 12 |
| EG007 | ARM H | Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. | 1 | 9 | 4 | 9 | 8 | 9 |
| EG008 | ARM I | Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG009 | ARM J | Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG010 | ARM K | Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. | 0 | 1 | 0 | 1 | 1 | 1 |
| TACHYCARDIA | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| ATYPICAL PNEUMONIA | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| ISCHAEMIC CEREBRAL INFARCTION | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| EAR PAIN | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment |
|
| DIPLOPIA | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| DRY EYE | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| EYE PAIN | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| EYE PRURITUS | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| OCULAR DISCOMFORT | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| OCULAR HYPERAEMIA | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| VISUAL IMPAIRMENT | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| VITREOUS FLOATERS | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| ANAL PRURITUS | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| ANORECTAL DISCOMFORT | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| APHTHOUS ULCER | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| BOWEL MOVEMENT IRREGULARITY | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| DENTAL CARIES | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| DIVERTICULUM INTESTINAL | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| EPIGASTRIC DISCOMFORT | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| FAECES DISCOLOURED | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| LIP DRY | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| OESOPHAGEAL DILATATION | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| TOOTH IMPACTED | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| EXERCISE TOLERANCE DECREASED | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| FACE OEDEMA | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| FEELING ABNORMAL | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| FEELING COLD | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| HERNIA PAIN | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| OEDEMA | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| PAIN | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| PERIPHERAL SWELLING | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| JAUNDICE | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
|
| ALLERGY TO ARTHROPOD BITE | Immune system disorders | MedDRA (20.0) | Systematic Assessment |
|
| LIVER TRANSPLANT REJECTION | Immune system disorders | MedDRA (20.0) | Systematic Assessment |
|
| SEASONAL ALLERGY | Immune system disorders | MedDRA (20.0) | Systematic Assessment |
|
| ACARODERMATITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| CYTOMEGALOVIRUS VIRAEMIA | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| FOLLICULITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| FUNGAL INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| HORDEOLUM | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| IMPETIGO | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| LOCALISED INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| ORAL CANDIDIASIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| ORAL HERPES | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| OTITIS MEDIA | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| SKIN INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| TINEA CRURIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| TINEA PEDIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| TOOTH INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| ACCIDENT | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| ARTHROPOD STING | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| EXCORIATION | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| LACERATION | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| MUSCLE STRAIN | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| POST-TRAUMATIC NECK SYNDROME | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| SCRATCH | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| SUNBURN | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| SUPERFICIAL INJURY OF EYE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| TOOTH FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| TRAUMATIC FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| BLOOD BICARBONATE DECREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| BLOOD POTASSIUM INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| BLOOD PRESSURE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| BLOOD TRIGLYCERIDES INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| BLOOD UREA INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| BLOOD URINE PRESENT | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| CARDIAC MURMUR | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| CYTOMEGALOVIRUS TEST POSITIVE | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| HAEMATOCRIT DECREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| IMMUNOSUPPRESSANT DRUG LEVEL INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| VITAMIN D DECREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| WEIGHT INCREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| GOUT | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| GOUTY ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| LIMB DISCOMFORT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| MUSCLE FATIGUE | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| MUSCLE TWITCHING | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| MUSCULOSKELETAL DISCOMFORT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| KERATOACANTHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
|
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
|
| BALANCE DISORDER | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| HYPERSOMNIA | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| MIGRAINE | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| ORTHOSTATIC INTOLERANCE | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| POOR QUALITY SLEEP | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| PRESYNCOPE | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| SEIZURE | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| SINUS HEADACHE | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| TENSION HEADACHE | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| TREMOR | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| TUNNEL VISION | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| ABNORMAL DREAMS | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| AFFECT LABILITY | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| APATHY | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| DEPRESSED MOOD | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| EMOTIONAL DISORDER | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| IRRITABILITY | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| LIBIDO INCREASED | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| MANIA | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| MOOD SWINGS | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| NIGHTMARE | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| RESTLESSNESS | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| ANURIA | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| CHROMATURIA | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| POLLAKIURIA | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| POLYURIA | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| PROTEINURIA | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
|
| GENITAL RASH | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
|
| PENILE BLISTER | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
|
| PROSTATITIS | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
|
| PROSTATOMEGALY | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
|
| VULVOVAGINAL PRURITUS | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
|
| CHOKING | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| DRY THROAT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| PARANASAL SINUS DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| SNEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| THROAT IRRITATION | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| UPPER-AIRWAY COUGH SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| ACNE | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| HAIR GROWTH ABNORMAL | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| PETECHIAE | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| PHOTOSENSITIVITY REACTION | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| RASH MACULAR | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| RASH PAPULAR | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| SKIN TIGHTNESS | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |