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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002793-23 | EudraCT Number |
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The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-790052 + PegIFNα-2a + Ribavirin | Experimental |
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| Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-790052 (NS5A Replication Complex Inhibitor) | Drug |
| ||
| Placebo matching BMS-790052 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 12 Week Sustained Virologic Response (SVR12) | Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels < lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12. | Week 12 (Follow-up period) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24. | Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scti Research Foundation | San Clemente | California | 92673 | United States | ||
| Umass Memorial Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26313445 | Derived | Hezode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourliere M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. Online ahead of print. |
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A total of 152 participants were enrolled in the study, of which 125 were randomized and 27 participants were not randomized due to 23 no longer met criteria, 1 withdrew consent, 1 due to administrative reason, and 2 other reasons. Of 125 randomized, 124 were treated and 1 was not treated due to withdrawal of consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Daclatasvir + PegIFNα2a + Ribavirin | Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Drug |
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| Pegylated-interferon alfa 2a | Drug |
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| Ribavirin | Drug |
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| Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24. | Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48 |
| Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively. | Post Treatment Weeks 12, 24 |
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation. | From Day 1 (start of study treatment) up to Follow-up Week 4 |
| Worcester |
| Massachusetts |
| 01655 |
| United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| Metropolitan Research | Annandale | Virginia | 22003 | United States |
| Local Institution | Bondy | 93143 | France |
| Local Institution | Créteil | 94000 | France |
| Local Institution | La Roche-sur-Yon | 85925 | France |
| Local Institution | Marseille | 13285 | France |
| Local Institution | Nice | 06202 | France |
| Local Institution | Orléans | 45067 | France |
| Local Institution | Paris | 75013 | France |
| Local Institution | Paris | 75475 | France |
| Local Institution | Strasbourg | 67091 | France |
| Local Institution | Toulouse | 31059 | France |
| Local Institution | Villejuif | 94804 | France |
| Local Institution | Thesaloniki | 54639 | Greece |
| Local Institution | Roma | 00149 | Italy |
| Local Institution | Torino | 10126 | Italy |
| Local Institution | San Juan | 00927 | Puerto Rico |
| Local Institution | A Coruña | 15706 | Spain |
| Local Institution | Barcelona | 08003 | Spain |
| Local Institution | Barcelona | 08035 | Spain |
| Local Institution | Madrid | 28046 | Spain |
| Local Institution | London | Greater London | SE5 9RS | United Kingdom |
| Local Institution | London | Greater London | SW17 0QT | United Kingdom |
| Local Institution | London | Greater London | W2 1NY | United Kingdom |
| FG001 | Placebo + PegIFNα2a + Ribavirin | Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| Follow Up Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Daclatasvir + PegIFNα2a + Ribavirin | Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response. |
| BG001 | Placebo + PegIFNα2a + Ribavirin | Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 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 |
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| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 12 Week Sustained Virologic Response (SVR12) | Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels < lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12. | The analysis was performed in modified Intent to treat population (ITT), defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. Missing values were imputed using backward imputation technique. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 (Follow-up period) |
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| Secondary | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24. | The analysis was performed in modified ITT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48 |
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| Secondary | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24. | The analysis was performed in modified ITT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48 |
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| Secondary | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively. | For SVR12; analysis was performed by backward imputation method, For SVR24: analysis was performed in Modified ITT population. | Posted | Number | Percentage of participants | Post Treatment Weeks 12, 24 |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation. | Analysis was performed on all treated participants. | Posted | Number | participants | From Day 1 (start of study treatment) up to Follow-up Week 4 |
|
From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
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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 | Daclatasvir + PegIFNα2a + Ribavirin | Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response. | 8 | 82 | 80 | 82 | ||
| EG001 | Placebo + PegIFNα2a + Ribavirin | Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks. | 2 | 42 | 39 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Basedow's disease | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Thyroid cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cluster headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.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 |
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Not provided
| ID | Term |
|---|---|
| C549273 | daclatasvir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
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| Other |
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| 21 to < 65 years |
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| >= 65 years |
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| Male |
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