Trial Outcomes & Findings for 3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection (NCT NCT01349465)

Last Updated: 2017-04-10

Results Overview

The SVR rate is the proportion (%) of participants with HCV RNA less than (\<) 25 International Units/milliliter (IU/mL).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

249 participants

Primary outcome timeframe

Last Available Visit (Month 36 for subjects completing the study)

Results posted on

2017-04-10

Participant Flow

In total 250 participants were screened and among those 249 were enrolled into the study (200 participants with SVR and 49 participants with no SVR).

Participant milestones

Participant milestones
Measure	SVR at Last Post-Therapy Follow-up Visit of Previous Study Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	No SVR at Last Post-Therapy Follow-up Visit of Previous Study Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.
Overall Study STARTED	200	49
Overall Study COMPLETED	182	27
Overall Study NOT COMPLETED	18	22

Reasons for withdrawal

Reasons for withdrawal
Measure	SVR at Last Post-Therapy Follow-up Visit of Previous Study Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	No SVR at Last Post-Therapy Follow-up Visit of Previous Study Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.
Overall Study Adverse Event	1	0
Overall Study Death	3	0
Overall Study Lost to Follow-up	10	1
Overall Study Withdrawal by Subject	4	2
Overall Study Subject Ineligible To Continue The Trial	0	19

Baseline Characteristics

3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SVR at Last Post-Therapy Follow-up Visit of Previous Study n=200 Participants Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	No SVR at Last Post-Therapy Follow-up Visit of Previous Study n=49 Participants Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	Total n=249 Participants Total of all reporting groups
Age, Continuous	52 years n=93 Participants	56 years n=4 Participants	53 years n=27 Participants
Sex: Female, Male Female	78 Participants n=93 Participants	17 Participants n=4 Participants	95 Participants n=27 Participants
Sex: Female, Male Male	122 Participants n=93 Participants	32 Participants n=4 Participants	154 Participants n=27 Participants

PRIMARY outcome

Timeframe: Last Available Visit (Month 36 for subjects completing the study)

Population: All participants with SVR at LPVPS were included in the population analysis set.

The SVR rate is the proportion (%) of participants with HCV RNA less than (\<) 25 International Units/milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	SVR at Last Post-Therapy Follow-up Visit of Previous Study n=200 Participants Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	No SVR at Last Post-Therapy Follow-up Visit of Previous Study Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.
Percentage of Participants Maintaining SVR at the Last Available Visit	100 Percentage of participants Interval 98.2 to 100.0	—

PRIMARY outcome

Timeframe: Baseline and Month 36

Population: "N" signifies number of participants with no SVR at LPVPS and with available sequence data. "n" defines the number of participants analyzed at specified time point.

Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.

Outcome measures

Outcome measures
Measure	SVR at Last Post-Therapy Follow-up Visit of Previous Study n=48 Participants Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	No SVR at Last Post-Therapy Follow-up Visit of Previous Study Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.
Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study NEM Return to Baseline at EOS (n=5)	0.0 Percentage of participants Interval 46.7 to 230.3	—
Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study NEM Change to New Profile at EOS (n=5)	0.0 Percentage of participants	—
Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study AEM Return to Baseline at EOS (n=43)	86.0 Percentage of participants	—
Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study AEM Change to New Profile at EOS (n=43)	7.0 Percentage of participants	—

PRIMARY outcome

Timeframe: Baseline and Month 36

Population: "N" signifies number of particpants with no SVR at LPVPS and with available sequence data. "n" defines the number of participants analyzed at specified time point.

Outcome measures

Outcome measures
Measure	SVR at Last Post-Therapy Follow-up Visit of Previous Study n=10 Participants Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	No SVR at Last Post-Therapy Follow-up Visit of Previous Study Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.
Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study NEM Return to Baseline at EOS (n=1)	0.0 Percentage of participants	—
Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study NEM Change to New Profile at EOS (n=1)	0.0 Percentage of participants	—
Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study AEM Return to Baseline at EOS (n=9)	88.9 Percentage of participants	—
Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study AEM Change to New Profile at EOS (n=9)	0.0 Percentage of participants	—

PRIMARY outcome

Timeframe: Baseline and Month 36

Population: "N" signifies number of particpants with no SVR at LPVPS and with available sequence data. "n" defines the number of participants analyzed at specified time point.

Outcome measures

Outcome measures
Measure	SVR at Last Post-Therapy Follow-up Visit of Previous Study n=38 Participants Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	No SVR at Last Post-Therapy Follow-up Visit of Previous Study Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.
Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study NEM Return to Baseline at EOS (n=4)	0.0 Percentage of participnats	—
Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study NEM Change to New Profile at EOS (n=4)	0.0 Percentage of participnats	—
Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study AEM Return to Baseline at EOS (n=34)	85.3 Percentage of participnats	—
Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study AEM Change to New Profile at EOS (n=34)	8.8 Percentage of participnats	—

SECONDARY outcome

Timeframe: End of study (at month 36)

Population: Late viral relapse was evaluated in all enrolled participants with SVR at LPVPS.

Relapse at any time after the LPVPS until the last individual visit of this study. All participants maintained SVR until the last available visit. No late viral relapse was therefore observed.

Outcome measures

Outcome measures
Measure	SVR at Last Post-Therapy Follow-up Visit of Previous Study n=200 Participants Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	No SVR at Last Post-Therapy Follow-up Visit of Previous Study Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.
Percentage of Participants With Late Viral Relapse	0 percentage of participants	—

SECONDARY outcome

Timeframe: End of study (at month 36)

Outcome measures

Outcome measures
Measure	SVR at Last Post-Therapy Follow-up Visit of Previous Study n=200 Participants Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	No SVR at Last Post-Therapy Follow-up Visit of Previous Study n=49 Participants Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability Adverse Events (AE)	4 Participants	1 Participants
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability Serious Adverse Events (SAE)	10 Participants	0 Participants

Adverse Events

SVR at Last Post-Therapy Follow-up Visit of Previous Study

Serious events: 10 serious events

Other events: 4 other events

Deaths: 0 deaths

No SVR at Last Post-Therapy Follow-up Visit of Previous Study

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Total

Serious events: 10 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	SVR at Last Post-Therapy Follow-up Visit of Previous Study n=200 participants at risk Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	No SVR at Last Post-Therapy Follow-up Visit of Previous Study n=49 participants at risk Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	Total n=249 participants at risk All Enrolled Subjects
Hepatobiliary disorders Bile duct stone	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Hepatobiliary disorders Cholecystitis chronic	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Blood and lymphatic system disorders Iron deficiency anaemia	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Investigations Alpha 1 foetoprotein increased	0.00% 0/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	2.0% 1/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Nervous system disorders Dysarthria	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Nervous system disorders Hemiparesis	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.

Additional Information

Study Responsible Scientist

Janssen Research & Development, LLC

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	SVR at Last Post-Therapy Follow-up Visit of Previous Study n=200 participants at risk Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	No SVR at Last Post-Therapy Follow-up Visit of Previous Study n=49 participants at risk Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study.	Total n=249 participants at risk All Enrolled Subjects
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	1.5% 3/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	1.2% 3/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Gastrointestinal disorders Abdominal pain upper	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Gastrointestinal disorders Ascites	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Gastrointestinal disorders Diarrhoea	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Gastrointestinal disorders Pancreatitis	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Gastrointestinal disorders Pancreatitis acute	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Gastrointestinal disorders Varices oesophageal	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
General disorders Chest pain	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
General disorders General physical health deterioration	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Hepatobiliary disorders Biliary colic	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Hepatobiliary disorders Cholangitis	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Hepatobiliary disorders Hydrocholecystis	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Cardiac disorders Myocardial infarction	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.
Nervous system disorders Cerebrovascular accident	0.50% 1/200 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.00% 0/49 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.	0.40% 1/249 • End of study (36 Months) Only Adverse Events associated with a study procedure or the use of any J\&J medication were collected from signing of the Informed Consent Form onwards until the last study visit and classified according to the existing procedures. If during the study, hepatocellular carcinoma (HCC) was diagnosed, it should be reported as an AE.