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VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients

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ClinicalTrials.gov Identifier: NCT00561925
Recruitment Status : Completed
First Posted : November 21, 2007
Results First Posted : January 19, 2012
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: nevirapine IR
Drug: nevirapine XR
Enrollment 1068
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NVP IR 200mg QD NVP IR 200mg BID NVP XR 400mg QD NVP XR NVP IR to XR
Hide Arm/Group Description Nevirapine immediate release 200 mg given once daily Nevirapine immediate release 200 mg given twice daily Nevirapine extended release 400 mg given once daily [Not Specified] [Not Specified]
Period Title: 14 Day Lead-In Period
Started 1068 0 0 0 0
Completed 1013 0 0 0 0
Not Completed 55 0 0 0 0
Reason Not Completed
Adverse Event             38             0             0             0             0
In/Exclusion criteria             4             0             0             0             0
Lost to Follow-up             4             0             0             0             0
Withdrawal by Subject             4             0             0             0             0
Other             5             0             0             0             0
Period Title: 144-week Double-blind, Double-dummy
Started 0 508 505 0 0
Completed 0 358 378 0 0
Not Completed 0 150 127 0 0
Reason Not Completed
Adverse Event             0             48             43             0             0
Protocol Violation             0             15             9             0             0
Lost to Follow-up             0             15             12             0             0
Withdrawal by Subject             0             19             7             0             0
Lack of Efficacy             0             36             33             0             0
Pregnancy             0             1             9             0             0
Death             0             6             3             0             0
Not treated with study drug             0             2             0             0             0
Other             0             8             11             0             0
Period Title: Open-Label Extension Period
Started 0 1 0 358 378
Completed 0 1 0 315 328
Not Completed 0 0 0 43 50
Reason Not Completed
Declined entry into extension period             0             0             0             43             50
Arm/Group Title NVP IR 200mg QD NVP IR 200mg BID NVP XR 400mg QD Total
Hide Arm/Group Description Nevirapine immediate release 200 mg tablets given once daily Nevirapine immediate release 200 mg tablets given twice daily Nevirapine extended release 400 mg tablets given once daily Total of all reporting groups
Overall Number of Baseline Participants 0 508 505 1013
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants 508 participants 505 participants 1013 participants
38.0  (9.7) 38.3  (9.7) 38.1  (9.7)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 508 participants 505 participants 1013 participants
18 to < 41 years 316 299 615
41 to < 56 years 165 182 347
56 to < 65 years 25 19 44
65 years or more 2 5 7
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 508 participants 505 participants 1013 participants
Female 75 74 149
Male 433 431 864
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 508 participants 505 participants 1013 participants
American Indian / Alaskan Native 6 8 14
Asian 13 15 28
Black 113 94 207
Hawaiian / Pacific Isle. 0 1 1
White 376 387 763
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 508 participants 505 participants 1013 participants
Hispanic / Latino 109 115 224
Not Hispanic / Latino 399 390 789
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 508 participants 505 participants 1013 participants
North America / Australia 149 141 290
Europe 253 257 510
Latin America 49 58 107
Africa 57 49 106
Smoking History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 508 participants 505 participants 1013 participants
Never smoked 250 224 474
Ex-smoker 81 86 167
Current smoker 177 195 372
Alcohol Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 508 participants 505 participants 1013 participants
Non drinker 151 168 319
Drinks - no interfere with trial 354 335 689
Drinks - could interfere with trial 3 2 5
1.Primary Outcome
Title Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Hide Description Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL
Time Frame week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Arm/Group Title NVP IR 200mg QD NVP IR 200mg BID NVP XR 400mg QD
Hide Arm/Group Description:
Nevirapine immediate release 200 mg tablets given once daily
Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine extended release 400 mg tablets given once daily
Overall Number of Participants Analyzed 0 506 505
Measure Type: Number
Unit of Measure: participants
Responder 384 409
Non responder 122 96
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NVP IR 200mg BID, NVP XR 400mg QD
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -10%
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran's statistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Cochran's statistic
Estimated Value 4.9
Confidence Interval 95%
-0.1 to 10.0
Estimation Comments Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.
2.Secondary Outcome
Title Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Hide Description [Not Specified]
Time Frame week 0 to 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Arm/Group Title NVP IR 200mg QD NVP IR 200mg BID NVP XR 400mg QD
Hide Arm/Group Description:
Nevirapine immediate release 200 mg tablets given once daily
Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine extended release 400 mg tablets given once daily
Overall Number of Participants Analyzed 0 506 505
Measure Type: Number
Unit of Measure: proportion of participants
Interval Week 0 to <2 1 1
Interval Week 2 to <4 0.84 0.865
Interval Week 4 to <6 0.838 0.865
Interval Week 6 to <8 0.834 0.865
Interval Week 8 to <12 0.834 0.863
Interval Week 12 to <16 0.832 0.861
Interval Week 16 to <24 0.83 0.859
Interval Week 24 to <32 0.822 0.848
Interval Week 32 to <40 0.806 0.832
Interval Week 40 to <48 0.792 0.816
Interval Week 48 to <60 0.777 0.808
Interval Week 60 to <72 0.759 0.788
Interval Week 72 to <84 0.733 0.766
Interval Week 84 to <96 0.713 0.745
Interval Week 96 to <108 0.686 0.719
Interval Week 108 to <120 0.662 0.697
Interval Week 120 to <132 0.65 0.681
Interval Week 132 to <144 0.63 0.671
Interval Week 144 to <168 0.61 0.66
3.Secondary Outcome
Title Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Hide Description Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL
Time Frame week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Arm/Group Title NVP IR 200mg QD NVP IR 200mg BID NVP XR 400mg QD
Hide Arm/Group Description:
Nevirapine immediate release 200 mg tablets given once daily
Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine extended release 400 mg tablets given once daily
Overall Number of Participants Analyzed 0 506 505
Measure Type: Number
Unit of Measure: participants
Responder 296 321
Non responder 210 184
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NVP IR 200mg BID, NVP XR 400mg QD
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -2%
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran's statistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Cochran's statistic
Estimated Value 4.84
Confidence Interval 95%
-1.11 to 10.79
Estimation Comments Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.
4.Secondary Outcome
Title Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Hide Description [Not Specified]
Time Frame week 0 to 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Arm/Group Title NVP IR 200mg QD NVP IR 200mg BID NVP XR 400mg QD
Hide Arm/Group Description:
Nevirapine immediate release 200 mg tablets given once daily
Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine extended release 400 mg tablets given once daily
Overall Number of Participants Analyzed 0 506 505
Measure Type: Number
Unit of Measure: proportion of participants
Interval Week 0 to <2 0 0
Interval Week 2 to <4 0.006 0.002
Interval Week 4 to <6 0.006 0.006
Interval Week 6 to <8 0.023 0.008
Interval Week 8 to <12 0.029 0.01
Interval Week 12 to <16 0.029 0.019
Interval Week 16 to <24 0.031 0.021
Interval Week 24 to <32 0.04 0.025
Interval Week 32 to <40 0.042 0.025
Interval Week 40 to <48 0.047 0.027
Interval Week 48 to <60 0.047 0.027
Interval Week 60 to <72 0.052 0.032
Interval Week 72 to <84 0.054 0.035
Interval Week 84 to <96 0.054 0.04
Interval Week 96 to <108 0.057 0.04
Interval Week 108 to <120 0.057 0.045
Interval Week 120 to <132 0.06 0.047
Interval Week 132 to <144 0.06 0.047
Interval Week 144 to <168 0.062 0.047
5.Secondary Outcome
Title Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population
Hide Description [Not Specified]
Time Frame baseline, week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases
Arm/Group Title NVP IR 200mg QD NVP IR 200mg BID NVP XR 400mg QD
Hide Arm/Group Description:
Nevirapine immediate release 200 mg tablets given once daily
Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine extended release 400 mg tablets given once daily
Overall Number of Participants Analyzed 0 506 505
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-2.7  (0.9) -2.8  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NVP IR 200mg BID, NVP XR 400mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7719
Comments [Not Specified]
Method ANCOVA
Comments Means adjusted for baseline HIV-1 viral load stratum
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval 95%
-0.08 to 0.06
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population
Hide Description [Not Specified]
Time Frame baseline, week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases
Arm/Group Title NVP IR 200mg QD NVP IR 200mg BID NVP XR 400mg QD
Hide Arm/Group Description:
Nevirapine immediate release 200 mg tablets given once daily
Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine extended release 400 mg tablets given once daily
Overall Number of Participants Analyzed 0 506 505
Mean (Standard Deviation)
Unit of Measure: cells/cubic millimeter
239.3  (171.4) 270.7  (183.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NVP IR 200mg BID, NVP XR 400mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method ANCOVA
Comments Means adjusted for baseline HIV-1 viral load stratum
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 32.87
Confidence Interval 95%
8.67 to 57.06
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Occurrence of Rashes
Hide Description Frequency of patients with drug related rash events by functional grouping
Time Frame until last patient completed 144 weeks (up to 193 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Arm/Group Title NVP IR NVP XR IR-IR/XR XR-IR/XR
Hide Arm/Group Description:
Patients received nevirapine IR during the 144 week blinded phase and nevirapine XR during open label extension
Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
Overall Number of Participants Analyzed 191 505 315 315
Measure Type: Number
Unit of Measure: participants
rash group I 9 11 6 0
rash group II 6 13 3 0
rash group IIA 4 5 1 0
rash group III 3 5 0 0
rash group IV 0 0 0 0
8.Secondary Outcome
Title Occurrence of Elevations in Laboratory Measurement by DAIDS Grade
Hide Description [Not Specified]
Time Frame until last patient completed 144 weeks (up to 193 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Arm/Group Title NVP IR NVP XR IR-IR/XR XR-IR/XR
Hide Arm/Group Description:
Patients received nevirapine IR during the 144 week blinded phase and nevirapine XR during open label extension
Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
Overall Number of Participants Analyzed 191 505 315 315
Measure Type: Number
Unit of Measure: participants
DAIDS grade 3 or 4 AEs 53 111 71 8
DAIDS grade 4 AEs 17 25 11 3
9.Secondary Outcome
Title Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Hide Description [Not Specified]
Time Frame week 0 to 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Arm/Group Title NVP IR NVP XR
Hide Arm/Group Description:
Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine extended release 400 mg tablets given once daily
Overall Number of Participants Analyzed 506 505
Measure Type: Number
Unit of Measure: cumulative probability
Interval Week 0 to <2 0.000 0.000
Interval Week 2 to <4 0.000 0.000
Interval Week 4 to <6 0.034 0.026
Interval Week 6 to <8 0.067 0.046
Interval Week 8 to <12 0.081 0.059
Interval Week 12 to <16 0.093 0.067
Interval Week 16 to <24 0.113 0.083
Interval Week 24 to <32 0.130 0.115
Interval Week 32 to <40 0.156 0.139
Interval Week 40 to <48 0.172 0.156
Interval Week 48 to <60 0.192 0.162
Interval Week 60 to <72 0.202 0.176
Interval Week 72 to <84 0.213 0.188
Interval Week 84 to <96 0.229 0.206
Interval Week 96 to <108 0.243 0.218
Interval Week 108 to <120 0.267 0.232
Interval Week 120 to <132 0.275 0.236
Interval Week 132 to <144 0.289 0.244
10.Secondary Outcome
Title Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Hide Description [Not Specified]
Time Frame week 0 to 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose
Arm/Group Title NVP IR NVP XR
Hide Arm/Group Description:
Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine extended release 400 mg tablets given once daily
Overall Number of Participants Analyzed 506 505
Measure Type: Number
Unit of Measure: cumulative probability
Interval Week 0 to <2 0.000 0.000
Interval Week 2 to <4 0.000 0.002
Interval Week 4 to <6 0.012 0.014
Interval Week 6 to <8 0.049 0.026
Interval Week 8 to <12 0.059 0.034
Interval Week 12 to <16 0.063 0.036
Interval Week 16 to <24 0.063 0.036
Interval Week 24 to <32 0.067 0.043
Interval Week 32 to <40 0.070 0.049
Interval Week 40 to <48 0.076 0.056
Interval Week 48 to <60 0.076 0.058
Interval Week 60 to <72 0.076 0.058
Interval Week >=72 0.076 0.070
11.Secondary Outcome
Title Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Hide Description [Not Specified]
Time Frame week 0 to 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose
Arm/Group Title NVP IR NVP XR
Hide Arm/Group Description:
Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine extended release 400 mg tablets given once daily
Overall Number of Participants Analyzed 506 505
Measure Type: Number
Unit of Measure: cumulative probability
Interval Week 0 to <2 0.000 0.000
Interval Week 2 to <4 0.000 0.000
Interval Week 4 to <6 0.006 0.002
Interval Week 6 to <8 0.027 0.006
Interval Week 8 to <12 0.033 0.008
Interval Week 12 to <16 0.039 0.008
Interval Week 16 to <24 0.039 0.008
Interval Week 24 to <32 0.042 0.015
Interval Week 32 to <40 0.044 0.019
Interval Week 40 to <48 0.053 0.028
Interval Week 48 to <60 0.053 0.031
Interval Week 60 to <72 0.053 0.033
Interval Week >=72 0.053 0.033
12.Secondary Outcome
Title Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Hide Description [Not Specified]
Time Frame week 0 to 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose
Arm/Group Title NVP IR NVP XR
Hide Arm/Group Description:
Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine extended release 400 mg tablets given once daily
Overall Number of Participants Analyzed 506 505
Measure Type: Number
Unit of Measure: cumulative probability
Interval Week 0 to <2 0.000 0.000
Interval Week 2 to <4 0.000 0.002
Interval Week 4 to <6 0.012 0.010
Interval Week 6 to <8 0.022 0.016
Interval Week 8 to <12 0.024 0.018
Interval Week 12 to <16 0.026 0.018
Interval Week 16 to <24 0.026 0.018
Interval Week 24 to <32 0.026 0.020
Interval Week 32 to <40 0.026 0.022
Interval Week 40 to <48 0.029 0.022
Interval Week 48 to <60 0.029 0.022
Interval Week 60 to <72 0.032 0.022
Interval Week >=72 0.038 0.026
13.Secondary Outcome
Title Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Hide Description [Not Specified]
Time Frame week 0 to 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose
Arm/Group Title NVP IR NVP XR
Hide Arm/Group Description:
Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine extended release 400 mg tablets given once daily
Overall Number of Participants Analyzed 506 505
Measure Type: Number
Unit of Measure: cumulative probability
Interval Week 0 to <2 0.000 0.000
Interval Week 2 to <4 0.000 0.000
Interval Week 4 to <6 0.002 0.006
Interval Week 6 to <8 0.004 0.008
Interval Week 8 to <12 0.004 0.010
Interval Week 12 to <16 0.004 0.010
Interval Week 16 to <24 0.004 0.010
Interval Week 24 to <32 0.004 0.010
Interval Week 32 to <40 0.004 0.010
Interval Week 40 to <48 0.004 0.010
Interval Week 48 to <60 0.004 0.010
Interval Week 60 to <72 0.004 0.010
Interval Week >=72 0.004 0.010
14.Secondary Outcome
Title Relative Bioavailability Trough C_pre,ss,1
Hide Description Relative bioavailability measured of trough concentrations. Analysis based on adjusted by-treatment geometric means, the adjusted geometric mean ratio of NVP XR : NVP IR and it's 90% confidence interval with p-value and the inter-individual geometric coefficient of variation.
Time Frame week 132
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients with trough drawn PK time window (12+/-2.5 hr for IR; 24+/-5hr for XR) at week 132 are included.
Arm/Group Title NVP IR NVP XR
Hide Arm/Group Description:
Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine extended release 400 mg tablets given once daily
Overall Number of Participants Analyzed 276 311
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
4567.03
(49.9%)
3634.26
(49.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NVP IR, NVP XR
Comments adjusted geometric mean ratio NVP XR : NVP IR
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence test with 80% -125% boundaries
Statistical Test of Hypothesis P-Value 0.5542
Comments p-value for ratio outside the interval 80%-125%
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter adjusted gMean
Estimated Value 79.58
Confidence Interval 90%
74.62 to 84.86
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.04
Estimation Comments Inter-individual gCV = 49.9
15.Secondary Outcome
Title Occurrence of Hepatic Events
Hide Description Frequency of patients with hepatitis symptoms
Time Frame until last patient completed 144 weeks (up to 193 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Arm/Group Title NVP IR NVP XR IR-IR/XR XR-IR/XR
Hide Arm/Group Description:
Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension
Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
Patients receiving nevirapine XR during open label extension who had previously received nevirapine IR during the pre week 144
Overall Number of Participants Analyzed 191 505 315 315
Measure Type: Number
Unit of Measure: participants
10 8 2 0
Time Frame Up to 193 weeks
Adverse Event Reporting Description Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
 
Arm/Group Title NVP IR 200mg QD NVP IR NVP XR NVP IR-IR/XR NVP XR-IR/XR
Hide Arm/Group Description Nevirapine immediate release 200 mg given once daily Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension Patients receiving nevirapine XR during open label extension who had previously receiving nevirapine IR during the pre week 144
All-Cause Mortality
NVP IR 200mg QD NVP IR NVP XR NVP IR-IR/XR NVP XR-IR/XR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
NVP IR 200mg QD NVP IR NVP XR NVP IR-IR/XR NVP XR-IR/XR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/1068 (1.87%)   33/191 (17.28%)   93/505 (18.42%)   50/315 (15.87%)   9/315 (2.86%) 
Blood and lymphatic system disorders           
Anaemia  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Neutropenia  1  1/1068 (0.09%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Normochromic normocytic anaemia  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Cardiac disorders           
Acute myocardial infarction  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Atrioventricular block  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Cardiac failure congestive  1  0/1068 (0.00%)  0/191 (0.00%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Mitral valve incompetence  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Myocardial infarction  1  0/1068 (0.00%)  1/191 (0.52%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Pericardial effusion  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Pericardial rub  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Pericarditis  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Supraventricular tachycardia  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Endocrine disorders           
Hyperthyroidism  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Eye disorders           
Retinal detachment  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  1/315 (0.32%)  1/315 (0.32%) 
Strabismus  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  1/315 (0.32%) 
Gastrointestinal disorders           
Anal fissure  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Colitis  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Diarrhoea  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  1/315 (0.32%) 
Enterocolitis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Gastritis  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Gastrooesophageal reflux disease  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Haemorrhoids  1  0/1068 (0.00%)  0/191 (0.00%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Inguinal hernia  1  1/1068 (0.09%)  0/191 (0.00%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Intestinal obstruction  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Nausea  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Oral disorder  1  1/1068 (0.09%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Pancreatitis chronic  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Peritoneal adhesions  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Proctitis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  2/315 (0.63%)  0/315 (0.00%) 
Retroperitoneal fibrosis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Umbilical hernia  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Vomiting  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
General disorders           
Face oedema  1  1/1068 (0.09%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Gait disturbance  1  1/1068 (0.09%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Hyperplasia  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Influenza like illness  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Polyserositis  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Pyrexia  1  2/1068 (0.19%)  0/191 (0.00%)  1/505 (0.20%)  1/315 (0.32%)  1/315 (0.32%) 
Hepatobiliary disorders           
Biliary colic  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Cholelithiasis  1  0/1068 (0.00%)  1/191 (0.52%)  2/505 (0.40%)  1/315 (0.32%)  0/315 (0.00%) 
Cytolytic hepatitis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Hepatic failure  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Hepatic necrosis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Hepatitis  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Hepatitis acute  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Hepatitis toxic  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Hepatotoxicity  1  0/1068 (0.00%)  2/191 (1.05%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Immune system disorders           
Drug hypersensitivity  1  1/1068 (0.09%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Hypersensitivity  1  1/1068 (0.09%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Infections and infestations           
AIDS encephalopathy  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Abdominal abscess  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Abscess  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Abscess intestinal  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Abscess limb  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Anal abscess  1  1/1068 (0.09%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Appendicitis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  2/315 (0.63%)  0/315 (0.00%) 
Appendicitis perforated  1  0/1068 (0.00%)  1/191 (0.52%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Arthritis bacterial  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Bronchitis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  1/315 (0.32%)  0/315 (0.00%) 
Bronchopneumonia  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Candidiasis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Cellulitis  1  0/1068 (0.00%)  1/191 (0.52%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Cerebral toxoplasmosis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Chronic sinusitis  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Endocarditis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Enteritis infectious  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Enterocolitis infectious  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Epiglottitis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Erysipelas  1  0/1068 (0.00%)  0/191 (0.00%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Eye infection syphilitic  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Furuncle  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Gastroenteritis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  2/315 (0.63%)  0/315 (0.00%) 
Gastroenteritis viral  1  1/1068 (0.09%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Giardiasis  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Groin abscess  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
H1N1 influenza  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Hepatitis A  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Herpes simplex  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Herpes zoster disseminated  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Laryngitis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Lobar pneumonia  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Lung abscess  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Meningitis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Meningitis bacterial  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Meningitis cryptococcal  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Meningitis histoplasma  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Meningitis tuberculous  1  1/1068 (0.09%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Meningitis viral  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Neurocryptococcosis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Orchitis  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Pilonidal cyst  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Pneumonia  1  0/1068 (0.00%)  3/191 (1.57%)  7/505 (1.39%)  0/315 (0.00%)  0/315 (0.00%) 
Pneumonia bacterial  1  1/1068 (0.09%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Pneumonia pneumococcal  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Pneumonia staphylococcal  1  1/1068 (0.09%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Pulmonary tuberculosis  1  0/1068 (0.00%)  1/191 (0.52%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Rectal abscess  1  1/1068 (0.09%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Sepsis  1  0/1068 (0.00%)  1/191 (0.52%)  3/505 (0.59%)  0/315 (0.00%)  0/315 (0.00%) 
Shigella infection  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  1/315 (0.32%)  0/315 (0.00%) 
Sinusitis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Subcutaneous abscess  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  1/315 (0.32%) 
Syphilis  1  1/1068 (0.09%)  0/191 (0.00%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Tuberculosis  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Urinary tract infection  1  0/1068 (0.00%)  2/191 (1.05%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Wound sepsis  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Injury, poisoning and procedural complications           
Alcohol poisoning  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Arthropod sting  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Burns second degree  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Concussion  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Contrast media reaction  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Contusion  1  0/1068 (0.00%)  1/191 (0.52%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Excoriation  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Fall  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  2/315 (0.63%)  0/315 (0.00%) 
Foot fracture  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  3/315 (0.95%)  0/315 (0.00%) 
Hand fracture  1  0/1068 (0.00%)  0/191 (0.00%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Head injury  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Humerus fracture  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Injury  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Intentional overdose  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Laceration  1  0/1068 (0.00%)  1/191 (0.52%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Ligament rupture  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Lower limb fracture  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Meniscus lesion  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  3/315 (0.95%)  0/315 (0.00%) 
Multiple injuries  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Neck injury  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Overdose  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Poisoning  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Postoperative wound complication  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Road traffic accident  1  0/1068 (0.00%)  0/191 (0.00%)  3/505 (0.59%)  0/315 (0.00%)  0/315 (0.00%) 
Stab wound  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Tendon rupture  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Thermal burn  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Tibia fracture  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  0/1068 (0.00%)  1/191 (0.52%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Aspartate aminotransferase increased  1  0/1068 (0.00%)  1/191 (0.52%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Blood bilirubin increased  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Catheterisation cardiac normal  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Gamma-glutamyltransferase increased  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Hepatic enzyme increased  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Transaminases increased  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Metabolism and nutrition disorders           
Dehydration  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Diabetic ketoacidosis  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Hypernatraemia  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Type 1 diabetes mellitus  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  1/1068 (0.09%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Back pain  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Groin pain  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Intervertebral disc protrusion  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  1/315 (0.32%) 
Osteoarthritis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Osteonecrosis  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Plica syndrome  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Anogenital warts  1  0/1068 (0.00%)  1/191 (0.52%)  3/505 (0.59%)  0/315 (0.00%)  0/315 (0.00%) 
Astrocytoma  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Bladder cancer recurrent  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Bladder neoplasm  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  1/315 (0.32%) 
Bone neoplasm malignant  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Burkitt's lymphoma  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Epithelioid sarcoma  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Hodgkin's disease  1  0/1068 (0.00%)  0/191 (0.00%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Kaposi's sarcoma  1  0/1068 (0.00%)  3/191 (1.57%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Non-Hodgkin's lymphoma  1  0/1068 (0.00%)  0/191 (0.00%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Oesophageal carcinoma  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Osteosarcoma localised  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Prostate cancer  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Uterine carcinoma in situ  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Uterine leiomyoma  1  0/1068 (0.00%)  1/191 (0.52%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Nervous system disorders           
Aphasia  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Cervical root pain  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Convulsion  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Disturbance in attention  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Encephalopathy  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Headache  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Hypoaesthesia  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Intracranial hypotension  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  1/315 (0.32%)  0/315 (0.00%) 
Myelopathy  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Paraparesis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Sciatica  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Syncope  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  1/315 (0.32%) 
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Abortion spontaneous incomplete  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Psychiatric disorders           
Acute stress disorder  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Adjustment disorder  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  1/315 (0.32%)  0/315 (0.00%) 
Aggression  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Agitation  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Alcohol abuse  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Anxiety  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Bipolar I disorder  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Completed suicide  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Delirium  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Depression  1  0/1068 (0.00%)  1/191 (0.52%)  4/505 (0.79%)  3/315 (0.95%)  0/315 (0.00%) 
Drug abuse  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Major depression  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  2/315 (0.63%)  0/315 (0.00%) 
Psychotic disorder  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  1/315 (0.32%) 
Social phobia  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Suicidal ideation  1  0/1068 (0.00%)  1/191 (0.52%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Suicide attempt  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  1/315 (0.32%)  0/315 (0.00%) 
Renal and urinary disorders           
Dysuria  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Nephrolithiasis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Renal failure  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Renal failure acute  1  0/1068 (0.00%)  0/191 (0.00%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Renal injury  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Reproductive system and breast disorders           
Benign prostatic hyperplasia  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Cervical dysplasia  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Epididymitis  1  1/1068 (0.09%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Haemorrhagic ovarian cyst  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Infertility female  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Menorrhagia  1  0/1068 (0.00%)  0/191 (0.00%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Vaginal haemorrhage  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Diaphragmatic hernia  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Dyspnoea  1  0/1068 (0.00%)  1/191 (0.52%)  2/505 (0.40%)  0/315 (0.00%)  0/315 (0.00%) 
Pleurisy  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Pulmonary embolism  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Pulmonary oedema  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Respiratory alkalosis  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Skin and subcutaneous tissue disorders           
Angioedema  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Drug rash with eosinophilia and systemic symptoms  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Erythema multiforme  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Hidradenitis  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  0/315 (0.00%)  1/315 (0.32%) 
Rash  1  5/1068 (0.47%)  1/191 (0.52%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Stevens-Johnson syndrome  1  2/1068 (0.19%)  4/191 (2.09%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Social circumstances           
Aborted pregnancy  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Alcohol use  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Surgical and medical procedures           
Abortion induced  1  0/1068 (0.00%)  0/191 (0.00%)  2/505 (0.40%)  1/315 (0.32%)  1/315 (0.32%) 
Inguinal hernia repair  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Removal of internal fixation  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Tooth extraction  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Vascular disorders           
Arteriosclerosis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Deep vein thrombosis  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Hypertension  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Hypotension  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Peripheral arterial occlusive disease  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Phlebitis  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Secondary hypertension  1  0/1068 (0.00%)  1/191 (0.52%)  0/505 (0.00%)  0/315 (0.00%)  0/315 (0.00%) 
Varicose vein  1  0/1068 (0.00%)  0/191 (0.00%)  1/505 (0.20%)  0/315 (0.00%)  0/315 (0.00%) 
Venous thrombosis  1  0/1068 (0.00%)  0/191 (0.00%)  0/505 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NVP IR 200mg QD NVP IR NVP XR NVP IR-IR/XR NVP XR-IR/XR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   308/1068 (28.84%)   131/191 (68.59%)   403/505 (79.80%)   271/315 (86.03%)   81/315 (25.71%) 
Gastrointestinal disorders           
Abdominal pain  1  8/1068 (0.75%)  7/191 (3.66%)  25/505 (4.95%)  25/315 (7.94%)  2/315 (0.63%) 
Diarrhoea  1  27/1068 (2.53%)  27/191 (14.14%)  94/505 (18.61%)  63/315 (20.00%)  7/315 (2.22%) 
Nausea  1  71/1068 (6.65%)  18/191 (9.42%)  38/505 (7.52%)  38/315 (12.06%)  3/315 (0.95%) 
Vomiting  1  16/1068 (1.50%)  11/191 (5.76%)  35/505 (6.93%)  22/315 (6.98%)  1/315 (0.32%) 
General disorders           
Fatigue  1  40/1068 (3.75%)  10/191 (5.24%)  34/505 (6.73%)  28/315 (8.89%)  2/315 (0.63%) 
Pyrexia  1  20/1068 (1.87%)  12/191 (6.28%)  25/505 (4.95%)  12/315 (3.81%)  2/315 (0.63%) 
Infections and infestations           
Bronchitis  1  7/1068 (0.66%)  12/191 (6.28%)  71/505 (14.06%)  35/315 (11.11%)  4/315 (1.27%) 
Gastroenteritis  1  5/1068 (0.47%)  10/191 (5.24%)  36/505 (7.13%)  27/315 (8.57%)  2/315 (0.63%) 
Herpes zoster  1  6/1068 (0.56%)  7/191 (3.66%)  26/505 (5.15%)  17/315 (5.40%)  1/315 (0.32%) 
Influenza  1  5/1068 (0.47%)  9/191 (4.71%)  33/505 (6.53%)  25/315 (7.94%)  0/315 (0.00%) 
Nasopharyngitis  1  10/1068 (0.94%)  17/191 (8.90%)  123/505 (24.36%)  87/315 (27.62%)  15/315 (4.76%) 
Pharyngitis  1  5/1068 (0.47%)  7/191 (3.66%)  33/505 (6.53%)  23/315 (7.30%)  2/315 (0.63%) 
Sinusitis  1  5/1068 (0.47%)  5/191 (2.62%)  37/505 (7.33%)  22/315 (6.98%)  2/315 (0.63%) 
Syphilis  1  1/1068 (0.09%)  8/191 (4.19%)  28/505 (5.54%)  19/315 (6.03%)  7/315 (2.22%) 
Upper respiratory tract infection  1  13/1068 (1.22%)  23/191 (12.04%)  83/505 (16.44%)  50/315 (15.87%)  12/315 (3.81%) 
Urinary tract infection  1  2/1068 (0.19%)  4/191 (2.09%)  26/505 (5.15%)  12/315 (3.81%)  5/315 (1.59%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  4/1068 (0.37%)  9/191 (4.71%)  33/505 (6.53%)  25/315 (7.94%)  9/315 (2.86%) 
Back pain  1  7/1068 (0.66%)  5/191 (2.62%)  40/505 (7.92%)  30/315 (9.52%)  8/315 (2.54%) 
Pain in extremity  1  4/1068 (0.37%)  5/191 (2.62%)  16/505 (3.17%)  20/315 (6.35%)  2/315 (0.63%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Anogenital warts  1  4/1068 (0.37%)  3/191 (1.57%)  29/505 (5.74%)  16/315 (5.08%)  0/315 (0.00%) 
Skin papilloma  1  3/1068 (0.28%)  4/191 (2.09%)  19/505 (3.76%)  16/315 (5.08%)  1/315 (0.32%) 
Nervous system disorders           
Headache  1  58/1068 (5.43%)  18/191 (9.42%)  61/505 (12.08%)  55/315 (17.46%)  3/315 (0.95%) 
Psychiatric disorders           
Anxiety  1  5/1068 (0.47%)  7/191 (3.66%)  20/505 (3.96%)  16/315 (5.08%)  2/315 (0.63%) 
Depression  1  8/1068 (0.75%)  7/191 (3.66%)  37/505 (7.33%)  31/315 (9.84%)  6/315 (1.90%) 
Insomnia  1  8/1068 (0.75%)  9/191 (4.71%)  27/505 (5.35%)  19/315 (6.03%)  1/315 (0.32%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  11/1068 (1.03%)  14/191 (7.33%)  52/505 (10.30%)  36/315 (11.43%)  3/315 (0.95%) 
Oropharyngeal pain  1  6/1068 (0.56%)  3/191 (1.57%)  30/505 (5.94%)  13/315 (4.13%)  3/315 (0.95%) 
Skin and subcutaneous tissue disorders           
Rash  1  74/1068 (6.93%)  26/191 (13.61%)  56/505 (11.09%)  25/315 (7.94%)  2/315 (0.63%) 
Vascular disorders           
Hypertension  1  5/1068 (0.47%)  13/191 (6.81%)  38/505 (7.52%)  22/315 (6.98%)  3/315 (0.95%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
For the lead-in-period with NVP IR 200mg QD, MedDRA Version 12.1 was used for AE/SAE reporting.
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.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00561925     History of Changes
Other Study ID Numbers: 1100.1486
2007-003654-29 ( EudraCT Number: EudraCT )
First Submitted: November 20, 2007
First Posted: November 21, 2007
Results First Submitted: December 13, 2011
Results First Posted: January 19, 2012
Last Update Posted: April 7, 2014