Trial Outcomes & Findings for A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation (NCT NCT01938625)
NCT ID: NCT01938625
Last Updated: 2018-11-21
Results Overview
Participants were considered to have achieved SVR12 if hepatitis C virus ribonucleic acid (HCV RNA) levels were less than (\<) 25 international unit per milliliter (IU/mL) detectable or undetectable at 12 weeks after the end of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Week 36
Results posted on
2018-11-21
Participant Flow
The study was conducted in 2 parts (part 1 and part 2) to sequentially enroll the participants. All analyses were conducted on the overall study population (part 1 and part 2 combined).
Participant milestones
| Measure |
Cyclosporine
Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Tacrolimus
Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
25
|
|
Overall Study
COMPLETED
|
10
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Cyclosporine
Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Tacrolimus
Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation
Baseline characteristics by cohort
| Measure |
Cyclosporine
n=10 Participants
Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Tacrolimus
n=25 Participants
Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.5 years
n=93 Participants
|
61 years
n=4 Participants
|
62 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
3 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
0 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 36Population: Intent to treat (ITT) analysis set included all enrolled participants who took at least 1 dose of investigational medication.
Participants were considered to have achieved SVR12 if hepatitis C virus ribonucleic acid (HCV RNA) levels were less than (\<) 25 international unit per milliliter (IU/mL) detectable or undetectable at 12 weeks after the end of treatment.
Outcome measures
| Measure |
Cyclosporine
n=10 Participants
Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Tacrolimus
n=25 Participants
Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After the End of Treatment (SVR 12)
|
100 percentage of participants
Interval 69.2 to 100.0
|
88 percentage of participants
Interval 68.8 to 97.5
|
SECONDARY outcome
Timeframe: Week 28Population: ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication.
Participants were considered to have achieved SVR4 if HCV RNA levels were (\<) 25 IU/mL detectable or undetectable at 4 weeks after the end of treatment.
Outcome measures
| Measure |
Cyclosporine
n=10 Participants
Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Tacrolimus
n=25 Participants
Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 Weeks After the End of Treatment (SVR 4)
|
100 percentage of participants
Interval 69.2 to 100.0
|
88 percentage of participants
Interval 68.8 to 97.5
|
SECONDARY outcome
Timeframe: Week 48Population: ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication.
Participants were considered to have achieved SVR 24 if hepatitis C virus ribonucleic acid (HCV RNA) levels were (\<) 25 IU/mL detectable or undetectable at 24 weeks after the end of treatment.
Outcome measures
| Measure |
Cyclosporine
n=10 Participants
Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Tacrolimus
n=25 Participants
Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 24 Weeks After the End of Treatment (SVR 24)
|
100 percentage of participants
Interval 69.2 to 100.0
|
88 percentage of participants
Interval 68.8 to 97.5
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 12, and 24Population: ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication.
Percentage of participants with detectable and undetectable HCV RNA (\<) 25 IU/mL during treatment at Weeks 2,4, 12, and 24 were reported.
Outcome measures
| Measure |
Cyclosporine
n=10 Participants
Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Tacrolimus
n=25 Participants
Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
|---|---|---|
|
Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable
Week 12: <25 IU/mL undetectable
|
100 percentage of participants
|
96 percentage of participants
|
|
Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable
Week 24: <25 IU/mL detectable
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable
Week 2: <25 IU/mL detectable
|
30 percentage of participants
|
36 percentage of participants
|
|
Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable
Week 2: <25 IU/mL undetectable
|
10 percentage of participants
|
12 percentage of participants
|
|
Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable
Week 4: <25 IU/mL detectable
|
30 percentage of participants
|
24 percentage of participants
|
|
Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable
Week 4: <25 IU/mL undetectable
|
70 percentage of participants
|
68 percentage of participants
|
|
Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable
Week 12: <25 IU/mL detectable
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable
Week 24: <25 IU/mL undetectable
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication.
Percentage of participants with HCV RNA (\<) 100 IU/mL at week 4 were reported.
Outcome measures
| Measure |
Cyclosporine
n=10 Participants
Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Tacrolimus
n=25 Participants
Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
|---|---|---|
|
Percentage of Participants With HCV RNA (<) 100 IU/mL at Week 4
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24 after actual EOT (week 24)Population: ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication.
On-treatment failure is defined as participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. This was to include participants with: 1) Viral breakthrough, defined as a confirmed increase of greater than (\>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA of \>100 IU/mL in participants whose HCV RNA had previously been \<lower limit of quantification (LLOQ) while on treatment; 2) Other with confirmed detectable HCV RNA at the actual end of treatment (example, completed, discontinued due to adverse events (AEs), withdrawal of consent).
Outcome measures
| Measure |
Cyclosporine
n=10 Participants
Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Tacrolimus
n=25 Participants
Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
|---|---|---|
|
Number of Participants With On-Treatment Failure
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Up to week 24Population: ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication.
Viral breakthrough is defined as a confirmed increase of \>1 log10 IU/mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of \>100 IU/mL in participants whose HCV RNA levels had previously been below the limit of quantification (\<25 IU/mL detectable) or undetectable (\<25 IU/mL undetectable) while on study treatment.
Outcome measures
| Measure |
Cyclosporine
n=10 Participants
Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Tacrolimus
n=25 Participants
Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
|---|---|---|
|
Number of Participants With Viral Breakthrough
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Up to Week 24 after actual EOT (week 24)Population: Intent to treat (ITT) analysis set included all enrolled participants who took at least 1 dose of investigational medication.
Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (\>=) LLOQ during follow-up.
Outcome measures
| Measure |
Cyclosporine
n=10 Participants
Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Tacrolimus
n=25 Participants
Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
|---|---|---|
|
Number of Participants With Viral Relapse
|
0 participants
|
0 participants
|
Adverse Events
Cyclosporine
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Tacrolimus
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cyclosporine
n=10 participants at risk
Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Tacrolimus
n=25 participants at risk
Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
General disorders
Pyrexia
|
30.0%
3/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Infections and infestations
Genital Herpes
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Nervous system disorders
Hepatic Encephalopathy
|
0.00%
0/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Renal and urinary disorders
Acute Kidney Injury
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Renal and urinary disorders
Micturition Disorder
|
0.00%
0/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Renal and urinary disorders
Renal Impairment
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Reproductive system and breast disorders
Prostatitis
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
Other adverse events
| Measure |
Cyclosporine
n=10 participants at risk
Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
Tacrolimus
n=25 participants at risk
Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
70.0%
7/10 • Up to 52 Weeks
|
44.0%
11/25 • Up to 52 Weeks
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.00%
0/10 • Up to 52 Weeks
|
8.0%
2/25 • Up to 52 Weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.0%
1/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • Up to 52 Weeks
|
12.0%
3/25 • Up to 52 Weeks
|
|
Eye disorders
Ocular Icterus
|
10.0%
1/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Eye disorders
Visual Acuity Reduced
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
10.0%
1/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Up to 52 Weeks
|
12.0%
3/25 • Up to 52 Weeks
|
|
Gastrointestinal disorders
Lip Dry
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Up to 52 Weeks
|
12.0%
3/25 • Up to 52 Weeks
|
|
Gastrointestinal disorders
Tongue Dry
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Up to 52 Weeks
|
8.0%
2/25 • Up to 52 Weeks
|
|
General disorders
Asthenia
|
50.0%
5/10 • Up to 52 Weeks
|
28.0%
7/25 • Up to 52 Weeks
|
|
General disorders
Fatigue
|
20.0%
2/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
General disorders
Gait Disturbance
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/10 • Up to 52 Weeks
|
8.0%
2/25 • Up to 52 Weeks
|
|
General disorders
Mucous Membrane Disorder
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
General disorders
Oedema Peripheral
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Hepatobiliary disorders
Cholangitis
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
20.0%
2/10 • Up to 52 Weeks
|
8.0%
2/25 • Up to 52 Weeks
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/10 • Up to 52 Weeks
|
8.0%
2/25 • Up to 52 Weeks
|
|
Infections and infestations
Oral Herpes
|
10.0%
1/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
1/10 • Up to 52 Weeks
|
8.0%
2/25 • Up to 52 Weeks
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/10 • Up to 52 Weeks
|
8.0%
2/25 • Up to 52 Weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
10.0%
1/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/10 • Up to 52 Weeks
|
8.0%
2/25 • Up to 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Up to 52 Weeks
|
8.0%
2/25 • Up to 52 Weeks
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Up to 52 Weeks
|
16.0%
4/25 • Up to 52 Weeks
|
|
Nervous system disorders
Restless Legs Syndrome
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Psychiatric disorders
Anger
|
10.0%
1/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Psychiatric disorders
Hallucination, Visual
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Renal and urinary disorders
Renal Failure
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Reproductive system and breast disorders
Vulvovaginal Pain
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Up to 52 Weeks
|
12.0%
3/25 • Up to 52 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
2/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/10 • Up to 52 Weeks
|
8.0%
2/25 • Up to 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • Up to 52 Weeks
|
0.00%
0/25 • Up to 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
10.0%
1/10 • Up to 52 Weeks
|
12.0%
3/25 • Up to 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Up to 52 Weeks
|
20.0%
5/25 • Up to 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Up to 52 Weeks
|
4.0%
1/25 • Up to 52 Weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Up to 52 Weeks
|
12.0%
3/25 • Up to 52 Weeks
|
Additional Information
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