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Trial record 32 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection (COMMAND-3)

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ClinicalTrials.gov Identifier: NCT01492426
Recruitment Status : Completed
First Posted : December 15, 2011
Results First Posted : June 3, 2016
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Daclatasvir
Drug: Telaprevir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Enrollment 605
Recruitment Details A total of 793 participants were recruited at 90 sites in 15 countries.
Pre-assignment Details Of the 793 participants, 605 were randomized to treatment. A total of 191 enrolled subjects did not enter the treatment period as they no longer met study entry criteria and a 602 participants were received treatment.
Arm/Group Title Daclatasvir + PEG-IFN Alpha-2a + Ribavirin Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Hide Arm/Group Description Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day). Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
Period Title: Treatment
Started 402 200
Completed 319 160
Not Completed 83 40
Reason Not Completed
Death             0             1
Other             1             0
Adverse Event             25             25
Lack of Efficacy             38             5
Participant withdrew consent             1             2
Poor compliance/noncompliance             1             0
Subject requested discontinue study drug             7             3
Lost to Follow-up             9             4
Participant does not meet study criteria             1             0
Period Title: Follow-Up
Started 384 [1] 191 [2]
Completed 359 181
Not Completed 25 10
Reason Not Completed
Protocol Requires no Follow-Up             2             1
Death             1             0
Other             4             2
Participant Withdrew Consent             6             1
Lost to Follow-up             12             6
[1]
This total number includes 319 who completed treatment plus 65 who rejoined for follow-up.
[2]
This total number includes 160 who completed treatment plus 31 who rejoined for follow-up.
Arm/Group Title Daclatasvir + PEG-IFN Alpha-2a + Ribavirin Telaprevir + PEG-IFN Alpha-2a + Ribavirin Total
Hide Arm/Group Description Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day). Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food. Total of all reporting groups
Overall Number of Baseline Participants 402 200 602
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 402 participants 200 participants 602 participants
46.5  (12.12) 47.6  (12.29) 46.9  (12.18)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 402 participants 200 participants 602 participants
Younger than 65 years 387 188 575
65 years and older 15 12 27
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 402 participants 200 participants 602 participants
Female
145
  36.1%
81
  40.5%
226
  37.5%
Male
257
  63.9%
119
  59.5%
376
  62.5%
1.Primary Outcome
Title Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Hide Description SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.
Time Frame Week 12 (Follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR12 response.
Arm/Group Title Daclatasvir + PEG-IFN Alpha-2a + Ribavirin Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
Overall Number of Participants Analyzed 268 134
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
85.1
(80.2 to 89.1)
81.3
(73.7 to 87.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Daclatasvir + PEG-IFN Alpha-2a + Ribavirin, Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Comments Percentage difference between SVR12 rate in the experimental and control arms was computed using a stratum-adjusted Mantel-Haenszel confidence interval (95% level) for the difference in rates. The stratification factors were IL28B rs1297860 single nucleotide polymorphism (CC or non-CC) and baseline cirrhosis status (absent or present), unless otherwise indicated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Test of noninferiority was based on noninferiority margin of -12% and 2-sided alpha level of 5%. That is, if the lower bound of the 95% CI > -12%, the Daclatasvir arm would be considered nonnferior to the telaprevir arm.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Test of noninferiority carried out by taking a confidence interval (CI) for the difference in rates (daclatasvir arm minus telapravir arm). If lower bound of 95% CI difference exceeded -12%, noninferiority was demonstrated. No p-value was computed.
Method Stratum-adjusted Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
-3.3 to 11.9
Parameter Dispersion
Type: Standard Deviation
Value: 3.885
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4
Hide Description RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for RVR response.
Arm/Group Title Daclatasvir + PEG-IFN Alpha-2a + Ribavirin Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000 – 1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
Overall Number of Participants Analyzed 268 134
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
77.2
(71.7 to 82.1)
79.1
(71.2 to 85.6)
3.Secondary Outcome
Title Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12
Hide Description eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment.
Time Frame Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for eRVR response.
Arm/Group Title Daclatasvir + PEG-IFN Alpha-2a + Ribavirin Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200mg per day was administered twice daily with food.
Overall Number of Participants Analyzed 268 134
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
75.0
(69.4 to 80.1)
73.1
(64.8 to 80.4)
4.Secondary Outcome
Title Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)
Hide Description cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for cEVR response.
Arm/Group Title Daclatasvir + PEG-IFN Alpha-2a+ Ribavirin Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
Overall Number of Participants Analyzed 268 134
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90.7
(86.5 to 93.9)
90.03
(84.0 to 94.7)
5.Secondary Outcome
Title Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)
Hide Description SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment.
Time Frame Week 24 (Follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR24 response.
Arm/Group Title Daclatasvir + PEG-IFN Alpha-2a+ Ribavirin Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
Overall Number of Participants Analyzed 268 134
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
84.3
(79.4 to 88.5)
80.6
(72.9 to 86.9)
6.Secondary Outcome
Title Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Hide Description SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment.
Time Frame Week 12 (Follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1a participants assessed for SVR12 response.
Arm/Group Title Daclatasvir + PEG-IFN Alpha-2a + Ribavirin Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
Overall Number of Participants Analyzed 134 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
64.9
(56.2 to 73.0)
69.7
(57.1 to 80.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daclatasvir + PEG-IFN Alpha-2a + Ribavirin Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Hide Arm/Group Description Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day) Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food
All-Cause Mortality
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Affected / at Risk (%) Affected / at Risk (%)
Total   26/402 (6.47%)   20/200 (10.00%) 
Blood and lymphatic system disorders     
Haemolytic anaemia  1  1/402 (0.25%)  0/200 (0.00%) 
Anaemia  1  0/402 (0.00%)  5/200 (2.50%) 
Cardiac disorders     
Palpitations  1  0/402 (0.00%)  1/200 (0.50%) 
Coronary artery disease  1  1/402 (0.25%)  0/200 (0.00%) 
Gastrointestinal disorders     
Duodenitis  1  1/402 (0.25%)  0/200 (0.00%) 
Ileus  1  1/402 (0.25%)  0/200 (0.00%) 
Vomiting  1  0/402 (0.00%)  1/200 (0.50%) 
Haemorrhoids  1  1/402 (0.25%)  1/200 (0.50%) 
Gastrointestinal haemorrhage  1  0/402 (0.00%)  1/200 (0.50%) 
Pancreatitis  1  0/402 (0.00%)  1/200 (0.50%) 
Hepatobiliary disorders     
Cholecystitis acute  1  0/402 (0.00%)  1/200 (0.50%) 
Cholelithiasis  1  1/402 (0.25%)  0/200 (0.00%) 
Infections and infestations     
Pneumonia  1  3/402 (0.75%)  0/200 (0.00%) 
Bronchopneumonia  1  0/402 (0.00%)  1/200 (0.50%) 
Cellulitis  1  2/402 (0.50%)  0/200 (0.00%) 
Proctitis infectious  1  0/402 (0.00%)  1/200 (0.50%) 
Peritonsillar abscess  1  1/402 (0.25%)  0/200 (0.00%) 
Sepsis  1  0/402 (0.00%)  1/200 (0.50%) 
Bursitis infective  1  1/402 (0.25%)  0/200 (0.00%) 
Lung infection  1  1/402 (0.25%)  0/200 (0.00%) 
Pneumococcal sepsis  1  1/402 (0.25%)  0/200 (0.00%) 
Bacteraemia  1  0/402 (0.00%)  1/200 (0.50%) 
Pneumonia mycoplasmal  1  1/402 (0.25%)  0/200 (0.00%) 
Tonsillitis  1  1/402 (0.25%)  0/200 (0.00%) 
Injury, poisoning and procedural complications     
Anaemia postoperative  1  1/402 (0.25%)  0/200 (0.00%) 
Overdose  1  1/402 (0.25%)  0/200 (0.00%) 
Concussion  1  1/402 (0.25%)  0/200 (0.00%) 
Intentional overdose  1  0/402 (0.00%)  1/200 (0.50%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  1/402 (0.25%)  1/200 (0.50%) 
Musculoskeletal and connective tissue disorders     
Bursitis  1  1/402 (0.25%)  0/200 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/402 (0.25%)  0/200 (0.00%) 
Lung adenocarcinoma  1  1/402 (0.25%)  0/200 (0.00%) 
Nervous system disorders     
Headache  1  0/402 (0.00%)  1/200 (0.50%) 
Syncope  1  1/402 (0.25%)  1/200 (0.50%) 
Convulsion  1  0/402 (0.00%)  1/200 (0.50%) 
Psychiatric disorders     
Psychotic disorder  1  0/402 (0.00%)  1/200 (0.50%) 
Mental status changes  1  0/402 (0.00%)  1/200 (0.50%) 
Bipolar I disorder  1  1/402 (0.25%)  0/200 (0.00%) 
Panic attack  1  1/402 (0.25%)  0/200 (0.00%) 
Suicidal ideation  1  0/402 (0.00%)  1/200 (0.50%) 
Depression  1  0/402 (0.00%)  2/200 (1.00%) 
Panic disorder  1  0/402 (0.00%)  1/200 (0.50%) 
Renal and urinary disorders     
Renal failure acute  1  0/402 (0.00%)  2/200 (1.00%) 
Respiratory, thoracic and mediastinal disorders     
Haemothorax  1  1/402 (0.25%)  0/200 (0.00%) 
Lung infiltration  1  1/402 (0.25%)  0/200 (0.00%) 
Pulmonary oedema  1  0/402 (0.00%)  1/200 (0.50%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  1/402 (0.25%)  0/200 (0.00%) 
Rash generalised  1  1/402 (0.25%)  0/200 (0.00%) 
Rash  1  1/402 (0.25%)  0/200 (0.00%) 
Drug reaction with eosinophilia and systemic symptoms  1  1/402 (0.25%)  1/200 (0.50%) 
Drug eruption  1  0/402 (0.00%)  1/200 (0.50%) 
Vascular disorders     
Circulatory collapse  1  0/402 (0.00%)  1/200 (0.50%) 
Venous thrombosis  1  0/402 (0.00%)  1/200 (0.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Affected / at Risk (%) Affected / at Risk (%)
Total   384/402 (95.52%)   193/200 (96.50%) 
Blood and lymphatic system disorders     
Anaemia  1  96/402 (23.88%)  98/200 (49.00%) 
Neutropenia  1  87/402 (21.64%)  27/200 (13.50%) 
Thrombocytopenia  1  19/402 (4.73%)  14/200 (7.00%) 
Ear and labyrinth disorders     
Vertigo  1  18/402 (4.48%)  12/200 (6.00%) 
Gastrointestinal disorders     
Diarrhoea  1  63/402 (15.67%)  35/200 (17.50%) 
Vomiting  1  26/402 (6.47%)  23/200 (11.50%) 
Abdominal pain upper  1  24/402 (5.97%)  15/200 (7.50%) 
Anorectal discomfort  1  3/402 (0.75%)  19/200 (9.50%) 
Nausea  1  88/402 (21.89%)  74/200 (37.00%) 
Haemorrhoids  1  7/402 (1.74%)  11/200 (5.50%) 
Dyspepsia  1  17/402 (4.23%)  16/200 (8.00%) 
Anal pruritus  1  3/402 (0.75%)  25/200 (12.50%) 
Proctalgia  1  2/402 (0.50%)  11/200 (5.50%) 
General disorders     
Fatigue  1  140/402 (34.83%)  81/200 (40.50%) 
Pyrexia  1  80/402 (19.90%)  42/200 (21.00%) 
Chills  1  31/402 (7.71%)  18/200 (9.00%) 
Influenza like illness  1  85/402 (21.14%)  38/200 (19.00%) 
Injection site erythema  1  21/402 (5.22%)  7/200 (3.50%) 
Injection site reaction  1  22/402 (5.47%)  5/200 (2.50%) 
Asthenia  1  109/402 (27.11%)  53/200 (26.50%) 
Infections and infestations     
Urinary tract infection  1  7/402 (1.74%)  10/200 (5.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  61/402 (15.17%)  39/200 (19.50%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  55/402 (13.68%)  14/200 (7.00%) 
Myalgia  1  61/402 (15.17%)  23/200 (11.50%) 
Muscle spasms  1  7/402 (1.74%)  11/200 (5.50%) 
Back pain  1  27/402 (6.72%)  14/200 (7.00%) 
Nervous system disorders     
Disturbance in attention  1  22/402 (5.47%)  10/200 (5.00%) 
Dizziness  1  32/402 (7.96%)  18/200 (9.00%) 
Dysgeusia  1  23/402 (5.72%)  21/200 (10.50%) 
Headache  1  137/402 (34.08%)  57/200 (28.50%) 
Psychiatric disorders     
Insomnia  1  71/402 (17.66%)  35/200 (17.50%) 
Anxiety  1  10/402 (2.49%)  16/200 (8.00%) 
Irritability  1  43/402 (10.70%)  27/200 (13.50%) 
Depression  1  29/402 (7.21%)  12/200 (6.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  48/402 (11.94%)  25/200 (12.50%) 
Cough  1  76/402 (18.91%)  31/200 (15.50%) 
Oropharyngeal pain  1  22/402 (5.47%)  11/200 (5.50%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  84/402 (20.90%)  34/200 (17.00%) 
Pruritus  1  107/402 (26.62%)  75/200 (37.50%) 
Rash  1  93/402 (23.13%)  69/200 (34.50%) 
Alopecia  1  86/402 (21.39%)  32/200 (16.00%) 
Erythema  1  16/402 (3.98%)  10/200 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01492426     History of Changes
Other Study ID Numbers: AI444-052
2011-004237-14 ( EudraCT Number )
First Submitted: December 13, 2011
First Posted: December 15, 2011
Results First Submitted: August 17, 2015
Results First Posted: June 3, 2016
Last Update Posted: June 3, 2016