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An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01447446
Collaborator
(none)
4,442
Enrollment
272
Locations
46
Duration (Months)
16.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
4442 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Non-Interventional Cohort Study on the Utilization and Impact of Dual and Triple Therapies Based on Pegylated Interferon for the Treatment of Chronic Hepatitis C
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin

Participants with chronic hepatitis C (CHC) receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed up for the duration of their treatment and for up to 24 weeks after therapy.

Drug: Peg-IFN Alfa-2a
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.

Drug: Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin

Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.

Drug: Peg-IFN Alfa-2b
Peg-IFN Alfa-2b according to standard of care and in line with local labeling.

Drug: Ribavirin
Ribavirin according to standard of care and in line with local labeling.
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin

Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.

Drug: Peg-IFN Alfa-2a
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.

Drug: Ribavirin
Ribavirin according to standard of care and in line with local labeling.

Drug: Boceprevir
Boceprevir according to standard of care and in line with local labeling.
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin

Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.

Drug: Peg-IFN Alfa-2b
Peg-IFN Alfa-2b according to standard of care and in line with local labeling.

Drug: Ribavirin
Ribavirin according to standard of care and in line with local labeling.

Drug: Boceprevir
Boceprevir according to standard of care and in line with local labeling.
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin

Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.

Drug: Peg-IFN Alfa-2a
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.

Drug: Ribavirin
Ribavirin according to standard of care and in line with local labeling.

Drug: Telaprevir
Telaprevir according to standard of care and in line with local labeling.
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin

Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.

Drug: Peg-IFN Alfa-2b
Peg-IFN Alfa-2b according to standard of care and in line with local labeling.

Drug: Ribavirin
Ribavirin according to standard of care and in line with local labeling.

Drug: Telaprevir
Telaprevir according to standard of care and in line with local labeling.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) [24 weeks after end of treatment (up to 118 weeks)]

    SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 24 weeks post completion of the treatment period.

  2. Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) [12 weeks after end of treatment (up to 118 weeks)]

    SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 weeks post completion of the treatment period.

Secondary Outcome Measures

  1. Virological Response at Various on Treatment Time Points and End of Treatment (EOT) [Week 4, 12 and End of treatment (EOT) (up to 96 weeks)]

    Virological response (VR) for dual therapy participants is defined as HCV RNA <50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) <=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) <=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ >50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection <=50 IU/mL (UVR). Results of HCV RNA tests with an LLD >50 IU/mL were considered as non-response for triple therapy participants.

  2. Virological Relapse After End of Treatment [Up to 24 weeks after EOT (up to 118 weeks)]

    Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA >=50 IU/mL).

  3. Virological Breakthrough [Up to EOT (up to 118 weeks)]

    Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by >=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation.

  4. Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions [Up to first 12 weeks of treatment]

    SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be <=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days.

  5. Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks [Up to 12 weeks]

    Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported.

  6. Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR) [Up to 98 weeks]

    Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir.

  7. Duration of Overall Treatment [Up to 118 weeks]

    Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks.

  8. Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC) [Up to 118 weeks]

  9. Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV) [Up to 72 weeks of treatment]

    Participants who prolonged the treatment period from 72 weeks were not reported.

  10. Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA) [Up to 72 weeks of treatment]

    Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA).

  11. Percentage of Participants With Concomitant Medical Condition at Baseline [Baseline]

  12. Percentage of Participants With Adverse Events (AE) [Up to 118 weeks]

    An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adult (according to local legislation) participants

  • Chronic hepatitis C (HCV)

  • Naive or treatment experienced, HIV-HCV co-infected or HCV mono-infected

  • Receiving treatment for HCV with pegylated interferons plus ribavirin or regimens containing direct-acting antivirals (DAA) according to standard of care and in line with current SPC/local labeling

Exclusion Criteria:

  • Contraindications according to SPC/local labeling

  • Treatment started >4 weeks before entering study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Antwerpen Belgium 2018
2 Antwerpen Belgium 2060
3 Bouge Belgium 5004
4 Brussels Belgium 1000
5 Bruxelles Belgium 1020
6 Bruxelles Belgium 1070
7 Bruxelles Belgium 1180
8 Bruxelles Belgium 1190
9 Bruxelles Belgium 1200
10 Edegem Belgium 2650
11 Gent Belgium 9000
12 Gilly (Charleroi) Belgium 6000
13 Hasselt Belgium 3500
14 Heusy Belgium 4802
15 Kortrijk Belgium 8500
16 Leuven Belgium 3000
17 Liège Belgium 4000
18 Mons Belgium 7000
19 Montignies sur Sambre Belgium 6061
20 Namur Belgium 5000
21 Oostende Belgium 8400
22 Roeselare Belgium 8800
23 Verviers Belgium 4800
24 Alexandria Egypt 0
25 Alexandria Egypt
26 Cairo Egypt 0
27 Cairo Egypt
28 Giza Egypt
29 Tanta Egypt
30 Kohtla-Järve Estonia 31025
31 Pärnu Estonia 80010
32 Tallinn Estonia 10138
33 Tallinn Estonia 10617
34 Tartu Estonia 51014
35 Aix En Provence France 13616
36 Amiens France 80054
37 Argenteuil France 95107
38 Avignon France 84902
39 Besancon France 25000
40 Besancon France 25030
41 Beziers France 34500
42 Boulogne Billancourt France 92104
43 Bourgoin Jallieu France 38300
44 Caen France 14033
45 Chambray Les Tours France 37171
46 Clichy France 92118
47 Creil France 60109
48 Creteil France 94010
49 Epinay-Sur-Seine France 93806
50 Evry France 91014
51 Freyming Merlebach France 57804
52 Gonesse France 95503
53 Grasse France 06130
54 Hyeres France 83407
55 La Tronche France 38700
56 Lagny Sur Marne France 77405
57 Lille France 59037
58 Limoges France 87042
59 Lomme France 59462
60 Lyon France 69009
61 Mantes La Jolie France 78200
62 Marseille France 13285
63 Meaux France 77104
64 Montpellier France 34070
65 Montpellier France 34295
66 Nice France 06202
67 Nimes France 30029
68 Orange France 84100
69 Orleans France 45100
70 Paris France 75571
71 Paris France 75651
72 Paris France 75679
73 Paris France 75908
74 Paris France 75970
75 Pau France 64046
76 Perpignan France 66046
77 Pessac France 33604
78 Reims France 51092
79 Rennes France 35033
80 Rouen France 76031
81 Saint Nazaire France 44606
82 St Laurent Du Var France 06700
83 St Priest En Jarez France 42277
84 Strasbourg France 67091
85 Suresnes France 92151
86 Toulon France 83000
87 Toulouse France 31059
88 Tourcoing France 59208
89 Vandoeuvre-les-nancy France 54511
90 Vannes France 56017
91 Villejuif France 94804
92 Villeneuve Maguelone France 34751
93 Villeneuve St Georges France 94195
94 Aachen Germany 52074
95 Berlin Germany 10243
96 Berlin Germany 10777
97 Burghausen Germany 84489
98 Düsseldorf Germany 40237
99 Erlangen Germany 91054
100 Essen Germany 45122
101 Kassel Germany 34117
102 Köln Germany 50937
103 Lübeck Germany 23562
104 Magdeburg Germany 39120
105 Mannheim Germany 68167
106 Rostock Germany 18057
107 Rottenburg Germany 72108
108 Tübingen Germany 72076
109 Alexandroupolis Greece 68100
110 Athens Greece 115 27
111 Athens Greece 11522
112 Athens Greece 11527
113 Ioannina Greece 455 00
114 Larissa Greece 41 110
115 Nea Kifissia Greece 14564
116 Patra Greece 265 04
117 Thessaloniki Greece 546 42
118 Ajka Hungary H-8400
119 Balassagyarmat Hungary 2660
120 Bekescsaba Hungary 5600
121 Budapest Hungary 1067
122 Budapest Hungary 1083
123 Budapest Hungary 1088
124 Budapest Hungary 1097
125 Budapest Hungary 1126
126 Budapest Hungary H-1125
127 Debrecen Hungary 4032
128 Debrecen Hungary H-4031
129 Gyula Hungary 5700
130 Kaposvar Hungary 7400
131 Kecskemet Hungary 6000
132 Miskolc Hungary H-3501
133 Nyíregyháza Hungary 4400
134 Pecs Hungary 7624
135 Sopron Hungary 9400
136 Szeged Hungary 6720
137 Szekesfehervar Hungary 8000
138 Szolnok Hungary 5000
139 Szombathely Hungary 9700
140 Székesfehérvár Hungary 8000
141 Tatabánya Hungary 2800
142 Zalaegerszeg Hungary 8900
143 Zalaegerszeg Hungary 8901
144 Dublin Ireland 4
145 Dublin Ireland 8
146 Dublin Ireland 9
147 Chieti Abruzzo Italy 66013
148 Reggio Calabria Calabria Italy 89100
149 Avellino Campania Italy 83100
150 Gragnano Campania Italy 80054
151 Marcianise Campania Italy 81025
152 Napoli Campania Italy 80131
153 Napoli Campania Italy 80136
154 Napoli Campania Italy 80138
155 Nocera Inferiore Campania Italy 84014
156 Nola Campania Italy 80035
157 Bologna Emilia-Romagna Italy 40138
158 Modena Emilia-Romagna Italy 41100
159 Parma Emilia-Romagna Italy 43126
160 Piacenza Emilia-Romagna Italy 29121
161 Udine Friuli-Venezia Giulia Italy 33100
162 Roma Lazio Italy 00149
163 Roma Lazio Italy 00152
164 Roma Lazio Italy 00161
165 Roma Lazio Italy 00165
166 Roma Lazio Italy 00189
167 Genova Liguria Italy 16132
168 Savona Liguria Italy 17100
169 Busto Arsizio Lombardia Italy 21052
170 Milano Lombardia Italy 20122
171 Milano Lombardia Italy 20123
172 Milano Lombardia Italy 20132
173 Milano Lombardia Italy 20142
174 Milano Lombardia Italy 20157
175 Milano Lombardia Italy 20162
176 Torrette Di Ancona Marche Italy 60020
177 Biella Piemonte Italy 13900
178 Cuorgnè (TO) Piemonte Italy 10082
179 Omegna (VB) Piemonte Italy 28887
180 Bari Puglia Italy 70124
181 Bisceglie Puglia Italy 70052
182 Castellana Grotte Puglia Italy 70013
183 San Giovanni Rotondo Puglia Italy 71013
184 Cagliari Sardegna Italy 09042
185 Cagliari Sardegna Italy 09100
186 Sassari Sardegna Italy 07100
187 Catania Sicilia Italy 95100
188 Catania Sicilia Italy 95126
189 Messina Sicilia Italy 98124
190 Palermo Sicilia Italy 90127
191 Arezzo Toscana Italy 52100
192 Firenze Toscana Italy 50134
193 Livorno Toscana Italy 57124
194 Padova Veneto Italy 35128
195 Safat Kuwait 13041
196 Baabda Lebanon 50
197 Beirut Lebanon 11-236
198 Beirut Lebanon 99999
199 Beirut Lebanon
200 Nabatieh Lebanon
201 Tripoli Lebanon 371 Tripoli
202 Skopje Macedonia, The Former Yugoslav Republic of 1000
203 Casablanca Morocco 20000
204 Casablanca Morocco 20100
205 Casablanca Morocco
206 Fes Morocco
207 Marrakech Morocco
208 Rabat Morocco 504
209 Rabat Morocco 62000
210 Muscat Oman P.O Box 35
211 Faisalabad Pakistan
212 Gujranwala Pakistan
213 Karachi Pakistan
214 Lahore Pakistan 20021
215 Lahore Pakistan
216 Rawalpindi Pakistan
217 Almada Portugal 2805-267
218 Amadora Portugal 2700-020
219 Aveiro Portugal 3810-096
220 Beja Portugal 7801-849
221 Coimbra Portugal 3041-801
222 Faro Portugal 8000-386
223 Lisboa Portugal 1349-019
224 Lisboa Portugal 1649-035
225 Porto Portugal 4099-001
226 Doha Qatar P.O.Box 3051
227 Bucharest Romania 021105
228 Bucharest Romania 022328
229 Cluj-napoca Romania 400162
230 Constanta Romania
231 Iasi Romania 700554
232 Iasi Romania 700620
233 Timisoara Romania 300167
234 Holy Makkah Saudi Arabia 21583-Makkah P.O.Box-53356
235 Riyadh Saudi Arabia 11159
236 Riyadh Saudi Arabia 11211
237 Belgrade Serbia 11000
238 Novi Sad Serbia 21000
239 Gävle Sweden 80187
240 Karlstad Sweden 65185
241 Uppsala Sweden 75185
242 Lugano Switzerland 6900
243 St. Gallen Switzerland 9007
244 Aleppo Syrian Arab Republic 6448
245 Kaohsiung Taiwan 00833
246 Kaohsiung Taiwan 807
247 Taichung Taiwan 40447
248 Taipei Taiwan 100
249 Taipei Taiwan 112
250 Taoyuan Taiwan 333
251 Adana Turkey 01100
252 Ankara Turkey 06100
253 Ankara Turkey 06290
254 Ankara Turkey 06800
255 Ankara Turkey
256 Hatay Turkey 31040
257 ISTANBULt Turkey
258 Istanbul Turkey 34390
259 Izmir Turkey 35100
260 Kayseri Turkey 38039
261 Mersin Turkey 33169
262 Tokat Turkey 60250
263 Trabzon Turkey 61080
264 Al Ain United Arab Emirates P.O.Box 1006
265 Dubai United Arab Emirates 4545
266 Sharjah United Arab Emirates P.O.Box: 5735 - Sharjah, UAE
267 Dundee United Kingdom DD1 9SY
268 Hull United Kingdom HU3 2JZ
269 London United Kingdom E1 1BB
270 London United Kingdom W2 1NY
271 Manchester United Kingdom M8 5RB
272 Nottingham United Kingdom NG7 2UH

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01447446
Other Study ID Numbers:
  • MV25599
First Posted:
Oct 6, 2011
Last Update Posted:
Mar 30, 2017
Last Verified:
Dec 1, 2016
Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Ribavirin
Interferon-alpha
Interferon alpha-2
Interferon-alfa-1b
Peginterferon alfa-2a
Peginterferon alfa-2b

Study Results

Participant Flow

Recruitment Details A total of 4442 participants were enrolled in the study, one participant had double enrollment. Out of 4442 participants, analyses were restricted to only core population, which included 4100 participants.
Pre-assignment Detail
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Period Title: Overall Study
STARTED 2312 496 292 93 821 86
COMPLETED 1590 331 192 60 610 54
NOT COMPLETED 722 165 100 33 211 32

Baseline Characteristics

Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin Total
Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Total of all reporting groups
Overall Participants 2312 496 292 93 821 86 4100
Age, Customized (participants) [Number]
Less Than or Equal to (<=) 45 Years
987
42.7%
178
35.9%
73
25%
21
22.6%
184
22.4%
14
16.3%
1457
35.5%
Greater (>) 45 years
1325
57.3%
318
64.1%
219
75%
72
77.4%
637
77.6%
72
83.7%
2643
64.5%
Sex: Female, Male (Count of Participants)
Female
910
39.4%
250
50.4%
108
37%
37
39.8%
331
40.3%
43
50%
1679
41%
Male
1402
60.6%
246
49.6%
184
63%
56
60.2%
490
59.7%
43
50%
2421
59%

Outcome Measures

1. Primary Outcome
Title Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)
Description SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 24 weeks post completion of the treatment period.
Time Frame 24 weeks after end of treatment (up to 118 weeks)

Outcome Measure Data

Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 2312 496 292 93 821 86
Number (95% Confidence Interval) [percentage of participants]
52.1
2.3%
49.4
10%
46.6
16%
50.5
54.3%
57.7
7%
47.7
55.5%
2. Primary Outcome
Title Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)
Description SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 weeks post completion of the treatment period.
Time Frame 12 weeks after end of treatment (up to 118 weeks)

Outcome Measure Data

Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 2312 496 292 93 821 86
Number (95% Confidence Interval) [percentage of participants]
54.3
2.3%
51.0
10.3%
50.0
17.1%
53.8
57.8%
62.0
7.6%
57.0
66.3%
3. Secondary Outcome
Title Virological Response at Various on Treatment Time Points and End of Treatment (EOT)
Description Virological response (VR) for dual therapy participants is defined as HCV RNA <50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) <=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) <=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ >50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection <=50 IU/mL (UVR). Results of HCV RNA tests with an LLD >50 IU/mL were considered as non-response for triple therapy participants.
Time Frame Week 4, 12 and End of treatment (EOT) (up to 96 weeks)

Outcome Measure Data

Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 2312 496 292 93 821 86
VR by Week 4
39.5
1.7%
40.1
8.1%
9.9
3.4%
9.7
10.4%
49.8
6.1%
51.2
59.5%
VR by Week 12
71.3
3.1%
67.7
13.6%
56.8
19.5%
59.1
63.5%
80.8
9.8%
73.3
85.2%
VR by EOT
73.6
3.2%
70.6
14.2%
67.1
23%
72.0
77.4%
74.9
9.1%
66.3
77.1%
4. Secondary Outcome
Title Virological Relapse After End of Treatment
Description Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA >=50 IU/mL).
Time Frame Up to 24 weeks after EOT (up to 118 weeks)

Outcome Measure Data

Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 1521 314 181 63 581 53
Number (95% Confidence Interval) [percentage of participants]
18.4
0.8%
19.7
4%
21.0
7.2%
20.6
22.2%
13.8
1.7%
7.5
8.7%
5. Secondary Outcome
Title Virological Breakthrough
Description Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by >=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation.
Time Frame Up to EOT (up to 118 weeks)

Outcome Measure Data

Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 2079 437 275 88 785 74
Number (95% Confidence Interval) [percentage of participants]
5.4
0.2%
4.8
1%
8.7
3%
15.9
17.1%
15.0
1.8%
21.6
25.1%
6. Secondary Outcome
Title Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions
Description SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be <=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days.
Time Frame Up to first 12 weeks of treatment

Outcome Measure Data

Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 116 33 29 7 79 9
SVR at Week 12 After EOT
37.1
1.6%
27.3
5.5%
20.7
7.1%
14.3
15.4%
35.4
4.3%
44.4
51.6%
SVR at Week 24 EOT
35.3
1.5%
24.2
4.9%
17.2
5.9%
14.3
15.4%
34.2
4.2%
44.4
51.6%
7. Secondary Outcome
Title Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks
Description Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported.
Time Frame Up to 12 weeks

Outcome Measure Data

Analysis Population Description
The data for all of the above mentioned virological responses were not collected and was not analyzed.
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 0 0 0 0 0 0
8. Secondary Outcome
Title Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR)
Description Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir.
Time Frame Up to 98 weeks

Outcome Measure Data

Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 292 93 821 86
Number (95% Confidence Interval) [percentage of participants]
37.7
1.6%
32.3
6.5%
45.6
15.6%
47.7
51.3%
9. Secondary Outcome
Title Duration of Overall Treatment
Description Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks.
Time Frame Up to 118 weeks

Outcome Measure Data

Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 2312 496 292 93 821 86
Mean (Standard Deviation) [Weeks]
34.2
(16.04)
31.3
(15.73)
35.2
(17.48)
35.3
(15.27)
33.2
(15.03)
31.2
(15.95)
10. Secondary Outcome
Title Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC)
Description
Time Frame Up to 118 weeks

Outcome Measure Data

Analysis Population Description
The data for this outcome measure were not collected and analyzed because the standard of care has changed significantly since the development of the study protocol, this comparison was no longer of practical value.
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 0 0 0 0 0 0
11. Secondary Outcome
Title Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV)
Description Participants who prolonged the treatment period from 72 weeks were not reported.
Time Frame Up to 72 weeks of treatment

Outcome Measure Data

Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 2312 496 292 93 821 86
Discontinued PEG-IFN During Week 1 to Week 12
5.7
0.2%
8.3
1.7%
9.2
3.2%
9.7
10.4%
9.9
1.2%
11.6
13.5%
Discontinued RBV During Week 1 to Week 12
6.3
0.3%
9.1
1.8%
9.6
3.3%
10.8
11.6%
10.8
1.3%
12.8
14.9%
Discontinued PEG-IFN During Week 13 to Week 24
13.5
0.6%
17.1
3.4%
16.8
5.8%
14.0
15.1%
10.2
1.2%
12.8
14.9%
Discontinued RBV During Week 13 to Week 24
22.1
1%
22.4
4.5%
17.1
5.9%
16.1
17.3%
13.9
1.7%
19.8
23%
Discontinued PEG-IFN During Week 25 to Week 48
41.7
1.8%
41.3
8.3%
30.1
10.3%
29.0
31.2%
41.0
5%
43.0
50%
Discontinued RBV During Week 25 to Week 48
43.0
1.9%
46.6
9.4%
41.1
14.1%
41.9
45.1%
44.9
5.5%
41.9
48.7%
Discontinued PEG-IFN During Week 49 to Week 72
36.2
1.6%
32.1
6.5%
41.1
14.1%
47.3
50.9%
38.9
4.7%
32.6
37.9%
Discontinued RBV During Week 49 to Week 72
26.6
1.2%
21.0
4.2%
29.1
10%
31.2
33.5%
30.3
3.7%
25.6
29.8%
12. Secondary Outcome
Title Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA)
Description Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA).
Time Frame Up to 72 weeks of treatment

Outcome Measure Data

Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 292 93 821 86
Discontinued DAA During Week 1 to Week 2
6.8
0.3%
7.5
1.5%
1.7
0.6%
4.7
5.1%
Discontinued DAA During Week 3 to Week 4
2.1
0.1%
1.1
0.2%
1.5
0.5%
4.7
5.1%
Discontinued DAA During Week 5 to Week 12
13.4
0.6%
8.6
1.7%
24.7
8.5%
22.1
23.8%
Discontinued DAA During Week 13 to Week 24
16.1
0.7%
18.3
3.7%
71.7
24.6%
68.6
73.8%
Discontinued DAA During Week 25 to Week 48
59.2
2.6%
64.5
13%
0.4
0.1%
0.0
0%
13. Secondary Outcome
Title Percentage of Participants With Concomitant Medical Condition at Baseline
Description
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 2312 496 292 93 821 86
Number [percentage of participants]
48.1
2.1%
50.4
10.2%
65.8
22.5%
68.8
74%
67.2
8.2%
41.9
48.7%
14. Secondary Outcome
Title Percentage of Participants With Adverse Events (AE)
Description An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
Time Frame Up to 118 weeks

Outcome Measure Data

Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Measure Participants 2312 496 292 93 821 86
Number [percentage of participants]
60.3
2.6%
65.7
13.2%
76.7
26.3%
88.2
94.8%
90.7
11%
87.2
101.4%

Adverse Events

Time Frame Up to 118 weeks
Adverse Event Reporting Description An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
All Cause Mortality
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 148/2312 (6.4%) 33/496 (6.7%) 43/292 (14.7%) 9/93 (9.7%) 163/821 (19.9%) 4/86 (4.7%)
Blood and lymphatic system disorders
Acquired haemophilia 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Agranulocytosis 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Anaemia 25/2312 (1.1%) 2/496 (0.4%) 9/292 (3.1%) 3/93 (3.2%) 57/821 (6.9%) 1/86 (1.2%)
Aplasia pure red cell 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Bone marrow failure 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Disseminated intravascular coagulation 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Haemolysis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Haemolytic anaemia 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Immune thrombocytopenic purpura 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Leukopenia 1/2312 (0%) 0/496 (0%) 2/292 (0.7%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Neutropenia 12/2312 (0.5%) 1/496 (0.2%) 4/292 (1.4%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Pancytopenia 5/2312 (0.2%) 0/496 (0%) 0/292 (0%) 1/93 (1.1%) 5/821 (0.6%) 0/86 (0%)
Thrombocytopenia 5/2312 (0.2%) 2/496 (0.4%) 2/292 (0.7%) 1/93 (1.1%) 4/821 (0.5%) 0/86 (0%)
Thrombotic thrombocytopenic purpura 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Cardiac disorders
Acute coronary syndrome 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Acute myocardial infarction 0/2312 (0%) 0/496 (0%) 0/292 (0%) 1/93 (1.1%) 0/821 (0%) 0/86 (0%)
Angina unstable 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Atrial fibrillation 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Atrial flutter 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Atrioventricular block 1/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Bundle branch block left 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Cardiac failure 1/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 4/821 (0.5%) 0/86 (0%)
Cardiac failure congestive 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Cardiovascular insufficiency 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Coronary artery disease 0/2312 (0%) 1/496 (0.2%) 1/292 (0.3%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Coronary artery occlusion 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Myocardial infarction 1/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Palpitations 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Tricuspid valve incompetence 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Congenital, familial and genetic disorders
Cerebrovascular arteriovenous malformation 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Ear and labyrinth disorders
Deafness 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Vertigo 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Endocrine disorders
Hypothyroidism 1/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Thyroiditis 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Eye disorders
Blindness unilateral 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Eye oedema 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Retinal detachment 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Retinal vein thrombosis 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Retinopathy 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Visual acuity reduced 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Gastrointestinal disorders
Abdominal discomfort 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Abdominal pain 2/2312 (0.1%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Abdominal pain lower 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Abdominal pain upper 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Alcoholic pancreatitis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Anal fissure 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Ascites 2/2312 (0.1%) 1/496 (0.2%) 1/292 (0.3%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Chronic gastritis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Colitis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Constipation 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Diarrhoea 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 1/821 (0.1%) 1/86 (1.2%)
Dysphagia 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Enterocolitis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Gastric ulcer perforation 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Gastritis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Gastrointestinal haemorrhage 2/2312 (0.1%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Haemorrhoidal haemorrhage 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Intestinal obstruction 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Nausea 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Oesophageal varices haemorrhage 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Oesophagitis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Pancreatitis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Pancreatitis acute 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Rectal haemorrhage 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Reflux gastritis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Retroperitoneal haemorrhage 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Upper gastrointestinal haemorrhage 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Varices oesophageal 1/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Vomiting 0/2312 (0%) 1/496 (0.2%) 2/292 (0.7%) 0/93 (0%) 3/821 (0.4%) 1/86 (1.2%)
General disorders
Asthenia 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 1/86 (1.2%)
Chest discomfort 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Death 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Fatigue 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
General physical health deterioration 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 6/821 (0.7%) 0/86 (0%)
Malaise 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Oedema 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Oedema peripheral 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Pyrexia 1/2312 (0%) 1/496 (0.2%) 1/292 (0.3%) 1/93 (1.1%) 3/821 (0.4%) 0/86 (0%)
Systemic inflammatory response syndrome 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Vascular stent restenosis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Hepatobiliary disorders
Bile duct stone 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Cholangitis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Cholecystitis acute 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Cholelithiasis 2/2312 (0.1%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Hepatic cirrhosis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 6/821 (0.7%) 0/86 (0%)
Hepatic failure 2/2312 (0.1%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Hepatitis acute 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Hepatocellular injury 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Hepatorenal syndrome 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Immune system disorders
Drug hypersensitivity 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Hypersensitivity 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Infections and infestations
Abdominal abscess 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Abscess 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Acinetobacter infection 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Appendicitis 3/2312 (0.1%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Arthritis bacterial 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Atypical mycobacterial infection 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Brain abscess 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Cellulitis 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Clostridium difficile colitis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Dermo-hypodermitis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
End stage AIDS 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Endocarditis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Enteritis infectious 0/2312 (0%) 0/496 (0%) 0/292 (0%) 1/93 (1.1%) 0/821 (0%) 0/86 (0%)
Erysipelas 2/2312 (0.1%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Escherichia sepsis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Extradural abscess 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Gastroenteritis 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 3/821 (0.4%) 0/86 (0%)
Hepatitis B 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Infected dermal cyst 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Infectious pleural effusion 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Listeria sepsis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Lower respiratory tract infection 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Lung abscess 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Lung infection 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Meningitis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Neutropenic sepsis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Orchitis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Peritonitis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Peritonitis bacterial 1/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Peritonsillar abscess 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Pneumonia 12/2312 (0.5%) 2/496 (0.4%) 1/292 (0.3%) 0/93 (0%) 6/821 (0.7%) 0/86 (0%)
Pulmonary sepsis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Pulmonary tuberculosis 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Pyelonephritis 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 5/821 (0.6%) 0/86 (0%)
Pyelonephritis acute 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Sepsis 1/2312 (0%) 2/496 (0.4%) 1/292 (0.3%) 0/93 (0%) 4/821 (0.5%) 0/86 (0%)
Septic arthritis staphylococcal 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Septic shock 1/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 4/821 (0.5%) 0/86 (0%)
Sinusitis 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Staphylococcal abscess 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Staphylococcal sepsis 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Streptococcal endocarditis 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Subcutaneous abscess 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Tracheobronchitis mycoplasmal 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Tuberculosis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Upper respiratory tract infection 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Urinary tract infection 5/2312 (0.2%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Urosepsis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Injury, poisoning and procedural complications
Alcohol poisoning 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Ankle fracture 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Cervical vertebral fracture 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Craniocerebral injury 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Cystitis radiation 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Facial bones fracture 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Fall 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Femoral neck fracture 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Fractured sacrum 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Head injury 0/2312 (0%) 1/496 (0.2%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Humerus fracture 2/2312 (0.1%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Multiple injuries 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Overdose 2/2312 (0.1%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Pneumocephalus 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Road traffic accident 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Skull fractured base 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Spinal fracture 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Subdural haematoma 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Synovial rupture 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
VIIIth nerve injury 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Investigations
Alpha 1 foetoprotein increased 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Blood creatinine increased 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Blood pressure increased 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Blood urea increased 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Weight decreased 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Metabolism and nutrition disorders
Cachexia 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Decreased appetite 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Dehydration 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Diabetes mellitus 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Diabetes mellitus inadequate control 1/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Diabetic ketoacidosis 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Hypokalaemia 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Malnutrition 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Tetany 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Type 1 diabetes mellitus 2/2312 (0.1%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Type 2 diabetes mellitus 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Musculoskeletal and connective tissue disorders
Compartment syndrome 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Muscle haemorrhage 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Muscular weakness 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Musculoskeletal pain 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Neck mass 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Osteitis 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Osteoarthritis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Psoriatic arthropathy 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Rheumatoid arthritis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Sacroiliitis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
B-cell lymphoma recurrent 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Breast cancer 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Cardiac myxoma 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Cholangiocarcinoma 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Diffuse large B-cell lymphoma 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Hepatic cancer 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Hepatic cancer recurrent 0/2312 (0%) 0/496 (0%) 0/292 (0%) 1/93 (1.1%) 1/821 (0.1%) 0/86 (0%)
Hepatocellular carcinoma 7/2312 (0.3%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 5/821 (0.6%) 0/86 (0%)
Lung neoplasm malignant 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Metastases to lung 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Non-hodgkin's lymphoma 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Oesophageal squamous cell carcinoma 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Papillary cystadenoma lymphomatosum 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Papillary thyroid cancer 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Pituitary tumour benign 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Prostate cancer 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Nervous system disorders
Carotid artery stenosis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Cognitive disorder 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Complex partial seizures 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Diabetic encephalopathy 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Diabetic hyperglycaemic coma 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Dysarthria 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Epilepsy 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Facial paresis 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Haemorrhage intracranial 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Hemiplegia 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Hepatic encephalopathy 1/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Ischaemic stroke 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Loss of consciousness 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Metabolic encephalopathy 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Occipital neuralgia 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Optic neuritis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 1/86 (1.2%)
Presyncope 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Sensorimotor disorder 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Subarachnoid haemorrhage 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Syncope 0/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Toxic leukoencephalopathy 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Transient ischaemic attack 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Wernicke's encephalopathy 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Psychiatric disorders
Acute psychosis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Alcoholism 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Bipolar disorder 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Confusional state 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Delirium 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Depression 5/2312 (0.2%) 2/496 (0.4%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Irritability 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Mental disorder 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Panic attack 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Persecutory delusion 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Restlessness 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Somatoform disorder 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Suicide attempt 1/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Renal and urinary disorders
Acute kidney injury 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 5/821 (0.6%) 0/86 (0%)
Calculus ureteric 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Haematuria 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Lupus nephritis 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Renal failure 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 3/821 (0.4%) 1/86 (1.2%)
Urethral stenosis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Reproductive system and breast disorders
Menometrorrhagia 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Prostatitis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Bronchospasm 1/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Dyspnoea 1/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 2/821 (0.2%) 0/86 (0%)
Lung infiltration 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Pneumonia aspiration 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Pneumonitis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 1/93 (1.1%) 0/821 (0%) 0/86 (0%)
Pulmonary arterial hypertension 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Pulmonary embolism 1/2312 (0%) 0/496 (0%) 1/292 (0.3%) 1/93 (1.1%) 2/821 (0.2%) 0/86 (0%)
Respiratory distress 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Skin and subcutaneous tissue disorders
Dermatitis allergic 2/2312 (0.1%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Eczema 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Erythema multiforme 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Excessive granulation tissue 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Pruritus 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Psoriasis 1/2312 (0%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Purpura 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Rash 1/2312 (0%) 0/496 (0%) 2/292 (0.7%) 0/93 (0%) 6/821 (0.7%) 1/86 (1.2%)
Rash generalised 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Toxic skin eruption 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Vascular purpura 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Social circumstances
Victim of homicide 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Surgical and medical procedures
Polypectomy 1/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Vascular disorders
Aortic aneurysm 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Deep vein thrombosis 2/2312 (0.1%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Hypertensive crisis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Peripheral venous disease 0/2312 (0%) 0/496 (0%) 0/292 (0%) 1/93 (1.1%) 0/821 (0%) 0/86 (0%)
Shock haemorrhagic 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Temporal arteritis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 0/93 (0%) 1/821 (0.1%) 0/86 (0%)
Venous thrombosis 0/2312 (0%) 0/496 (0%) 0/292 (0%) 1/93 (1.1%) 0/821 (0%) 0/86 (0%)
Venous thrombosis limb 0/2312 (0%) 0/496 (0%) 1/292 (0.3%) 0/93 (0%) 0/821 (0%) 0/86 (0%)
Other (Not Including Serious) Adverse Events
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1225/2312 (53%) 287/496 (57.9%) 207/292 (70.9%) 79/93 (84.9%) 709/821 (86.4%) 72/86 (83.7%)
Blood and lymphatic system disorders
Anaemia 435/2312 (18.8%) 141/496 (28.4%) 112/292 (38.4%) 42/93 (45.2%) 351/821 (42.8%) 43/86 (50%)
Neutropenia 258/2312 (11.2%) 64/496 (12.9%) 35/292 (12%) 25/93 (26.9%) 84/821 (10.2%) 24/86 (27.9%)
Leukopenia 129/2312 (5.6%) 47/496 (9.5%) 8/292 (2.7%) 6/93 (6.5%) 59/821 (7.2%) 31/86 (36%)
Thrombocytopenia 138/2312 (6%) 26/496 (5.2%) 31/292 (10.6%) 5/93 (5.4%) 94/821 (11.4%) 23/86 (26.7%)
Gastrointestinal disorders
Nausea 85/2312 (3.7%) 30/496 (6%) 36/292 (12.3%) 24/93 (25.8%) 134/821 (16.3%) 11/86 (12.8%)
Diarrhoea 59/2312 (2.6%) 8/496 (1.6%) 17/292 (5.8%) 11/93 (11.8%) 78/821 (9.5%) 4/86 (4.7%)
Anal pruritus 1/2312 (0%) 0/496 (0%) 0/292 (0%) 2/93 (2.2%) 61/821 (7.4%) 4/86 (4.7%)
Vomiting 26/2312 (1.1%) 9/496 (1.8%) 8/292 (2.7%) 5/93 (5.4%) 47/821 (5.7%) 6/86 (7%)
Haemorrhoids 9/2312 (0.4%) 1/496 (0.2%) 5/292 (1.7%) 2/93 (2.2%) 47/821 (5.7%) 6/86 (7%)
Abdominal pain 32/2312 (1.4%) 2/496 (0.4%) 10/292 (3.4%) 6/93 (6.5%) 39/821 (4.8%) 0/86 (0%)
Dry mouth 21/2312 (0.9%) 3/496 (0.6%) 7/292 (2.4%) 4/93 (4.3%) 27/821 (3.3%) 5/86 (5.8%)
General disorders
Asthenia 236/2312 (10.2%) 72/496 (14.5%) 53/292 (18.2%) 23/93 (24.7%) 245/821 (29.8%) 8/86 (9.3%)
Fatigue 244/2312 (10.6%) 53/496 (10.7%) 68/292 (23.3%) 23/93 (24.7%) 170/821 (20.7%) 13/86 (15.1%)
Influenza like illness 167/2312 (7.2%) 38/496 (7.7%) 31/292 (10.6%) 17/93 (18.3%) 97/821 (11.8%) 7/86 (8.1%)
Pyrexia 147/2312 (6.4%) 45/496 (9.1%) 13/292 (4.5%) 10/93 (10.8%) 33/821 (4%) 4/86 (4.7%)
Investigations
Weight decreased 97/2312 (4.2%) 28/496 (5.6%) 14/292 (4.8%) 9/93 (9.7%) 47/821 (5.7%) 1/86 (1.2%)
Haemoglobin decreased 22/2312 (1%) 9/496 (1.8%) 1/292 (0.3%) 0/93 (0%) 16/821 (1.9%) 13/86 (15.1%)
Neutrophil count increased 6/2312 (0.3%) 1/496 (0.2%) 0/292 (0%) 0/93 (0%) 7/821 (0.9%) 5/86 (5.8%)
Metabolism and nutrition disorders
Decreased appetite 101/2312 (4.4%) 47/496 (9.5%) 25/292 (8.6%) 16/93 (17.2%) 118/821 (14.4%) 8/86 (9.3%)
Musculoskeletal and connective tissue disorders
Arthralgia 45/2312 (1.9%) 19/496 (3.8%) 18/292 (6.2%) 6/93 (6.5%) 53/821 (6.5%) 5/86 (5.8%)
Myalgia 76/2312 (3.3%) 19/496 (3.8%) 8/292 (2.7%) 8/93 (8.6%) 53/821 (6.5%) 3/86 (3.5%)
Nervous system disorders
Headache 102/2312 (4.4%) 39/496 (7.9%) 33/292 (11.3%) 15/93 (16.1%) 94/821 (11.4%) 5/86 (5.8%)
Dysgeusia 13/2312 (0.6%) 5/496 (1%) 33/292 (11.3%) 14/93 (15.1%) 40/821 (4.9%) 1/86 (1.2%)
Dizziness 40/2312 (1.7%) 19/496 (3.8%) 9/292 (3.1%) 8/93 (8.6%) 24/821 (2.9%) 2/86 (2.3%)
Psychiatric disorders
Insomnia 121/2312 (5.2%) 40/496 (8.1%) 18/292 (6.2%) 7/93 (7.5%) 100/821 (12.2%) 4/86 (4.7%)
Depression 82/2312 (3.5%) 32/496 (6.5%) 15/292 (5.1%) 8/93 (8.6%) 70/821 (8.5%) 3/86 (3.5%)
Irritability 48/2312 (2.1%) 7/496 (1.4%) 10/292 (3.4%) 4/93 (4.3%) 49/821 (6%) 1/86 (1.2%)
Respiratory, thoracic and mediastinal disorders
Cough 103/2312 (4.5%) 23/496 (4.6%) 23/292 (7.9%) 10/93 (10.8%) 72/821 (8.8%) 1/86 (1.2%)
Dyspnoea 54/2312 (2.3%) 16/496 (3.2%) 18/292 (6.2%) 9/93 (9.7%) 72/821 (8.8%) 4/86 (4.7%)
Oropharyngeal pain 10/2312 (0.4%) 4/496 (0.8%) 5/292 (1.7%) 5/93 (5.4%) 9/821 (1.1%) 0/86 (0%)
Skin and subcutaneous tissue disorders
Pruritus 160/2312 (6.9%) 55/496 (11.1%) 37/292 (12.7%) 16/93 (17.2%) 240/821 (29.2%) 10/86 (11.6%)
Rash 85/2312 (3.7%) 25/496 (5%) 24/292 (8.2%) 9/93 (9.7%) 155/821 (18.9%) 9/86 (10.5%)
Dry skin 51/2312 (2.2%) 11/496 (2.2%) 22/292 (7.5%) 10/93 (10.8%) 66/821 (8%) 3/86 (3.5%)
Alopecia 69/2312 (3%) 20/496 (4%) 14/292 (4.8%) 10/93 (10.8%) 51/821 (6.2%) 2/86 (2.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact

Name/Title Medical Communications
Organization Hoffmann-La Roche
Phone 800 821-8590
Email genentech@druginfo.com
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01447446
Other Study ID Numbers:
  • MV25599
First Posted:
Oct 6, 2011
Last Update Posted:
Mar 30, 2017
Last Verified:
Dec 1, 2016