Trial Outcomes & Findings for Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C (NCT NCT02817594)
NCT ID: NCT02817594
Last Updated: 2019-05-17
Results Overview
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.
Recruitment status
COMPLETED
Target enrollment
51 participants
Primary outcome timeframe
12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Results posted on
2019-05-17
Participant Flow
Participants chronically infected with hepatitis C virus (HCV) were enrolled at 9 centers in the Netherlands.
Participants were prescribed the interferon-free combination regimen of paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) at the discretion of the physician in accordance with local clinical practice and label.
Participant milestones
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
Received Treatment
|
50
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Other
|
1
|
|
Overall Study
Did Not Receive Treatment
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=50 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.
|
|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 12.7 • n=50 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=50 Participants
|
|
Hepatitis C Virus Genotype
Genotype 1a
|
9 Participants
n=50 Participants
|
|
Hepatitis C Virus Genotype
Genotype 1b
|
34 Participants
n=50 Participants
|
|
Hepatitis C Virus Genotype
Genotype 4a
|
2 Participants
n=50 Participants
|
|
Hepatitis C Virus Genotype
Genotype 4d
|
1 Participants
n=50 Participants
|
|
Hepatitis C Virus Genotype
Genotype 4n
|
1 Participants
n=50 Participants
|
|
Hepatitis C Virus Genotype
Genotype 4r
|
1 Participants
n=50 Participants
|
|
Hepatitis C Virus Genotype
Genotype 4, Subtype Unknown
|
2 Participants
n=50 Participants
|
|
Cirrhosis status
No cirrhosis
|
40 Participants
n=50 Participants
|
|
Cirrhosis status
Transition to cirrhosis
|
4 Participants
n=50 Participants
|
|
Cirrhosis status
Cirrhosis
|
6 Participants
n=50 Participants
|
|
Years Since Diagnosis of HCV Infection
|
12.3 years
STANDARD_DEVIATION 12.41 • n=49 Participants • Participants with available data
|
|
HCV Ribonucleic Acid (RNA) Level
|
5.98 log10 IU/mL
STANDARD_DEVIATION 0.925 • n=47 Participants • Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) with non-missing RNA data.
|
|
Assigned Treatment Regimen
2 DAA without RBV for 12 weeks
|
2 Participants
n=50 Participants
|
|
Assigned Treatment Regimen
2 DAA with RBV for 12 weeks
|
4 Participants
n=50 Participants
|
|
Assigned Treatment Regimen
3 DAA without RBV for 12 weeks
|
34 Participants
n=50 Participants
|
|
Assigned Treatment Regimen
3 DAA with RBV for 12 weeks
|
10 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)Population: The Core Population, defined as enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=48 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
|
|---|---|
|
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
|
89.6 percentage of participants
Interval 77.8 to 95.5
|
SECONDARY outcome
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen)Population: The Core Population defined as enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=48 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
|
|---|---|
|
Percentage of Participants Achieving Virological Response at End of Treatment
|
95.8 percentage of participants
Interval 86.0 to 98.8
|
SECONDARY outcome
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)Population: The Core Population with sufficient follow-up data regarding SVR12
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. The Core Population with sufficient follow-up data regarding SVR12 included all core population participants who * had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE REGIMEN * or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline * or had HCV RNA \< 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=47 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
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|---|---|
|
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment
|
91.5 percentage of participants
Interval 80.1 to 96.6
|
SECONDARY outcome
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.Population: The Core Population with VR at EOT and who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70.
Relapse was defined as participants with a virologic response (VR; HCV RNA \< 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=44 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
|
|---|---|
|
Percentage of Participants With Relapse
|
6.8 percentage of participants
Interval 2.3 to 18.2
|
SECONDARY outcome
Timeframe: 12 or 24 weeks (depending on the treatment regimen)Population: The Core Population with virological response on-treatment and with at least one on-treatment measurement thereafter (including EOT).
Breakthrough was defined as at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=8 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
|
|---|---|
|
Percentage of Participants With Breakthrough
|
0.0 percentage of participants
Interval 0.0 to 32.4
|
SECONDARY outcome
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)Population: The Core Population
SVR12 non-response was categorized according to the following: * On-treatment virologic failure (breakthrough \[at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment\] or failure to suppress \[each measured on-treatment HCV RNA value ≥ 50 IU/mL\]); * Relapse, defined as HCV RNA \< 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened); * Premature treatment discontinuation with no on-treatment virologic failure; * Missing SVR12 data and/or none of the above criteria.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=48 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
|
|---|---|
|
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
On-treatment virologic failure
|
0 Participants
|
|
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
Relapse
|
3 Participants
|
|
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
Premature treatment discontinuation
|
1 Participants
|
|
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
None of the above criteria
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.Population: The Core Population
Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=48 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
|
|---|---|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
> 105 %
|
1 Participants
|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
> 95% to ≤ 105%
|
41 Participants
|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
> 80% to ≤ 95%
|
2 Participants
|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
> 50% to ≤ 80%
|
2 Participants
|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
≤ 50%
|
1 Participants
|
|
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
Missing
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimenPopulation: The Core Population who were prescribed ribavirin.
Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=14 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
|
|---|---|
|
Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin
> 105%
|
1 Participants
|
|
Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin
> 95% to ≤ 105%
|
11 Participants
|
|
Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin
> 80% to ≤ 95%
|
0 Participants
|
|
Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin
> 50% to ≤ 80%
|
0 Participants
|
|
Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin
≤ 50%
|
2 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.Population: The Core Population who were prescribed ribavirin.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=14 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
|
|---|---|
|
Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days
|
96.0 percentage of days
Standard Deviation 19.62
|
SECONDARY outcome
Timeframe: From first dose of study drug through 30 days after last dose (16 weeks).Population: The Safety Population, defined as all enrolled participants who received at least one dose of the ABBVIE regimen.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=50 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
|
|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Any adverse event
|
32 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Serious adverse event
|
2 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Pregnancy
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatmentPopulation: The Core Population with available data at baseline and each time point.
The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS). Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=43 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
|
|---|---|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
End of treatment
|
0.000 units on a scale
Interval -0.131 to 0.015
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
12 weeks after end of treatment
|
0.000 units on a scale
Interval -0.082 to 0.096
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
24 weeks after end of treatment
|
0.000 units on a scale
Interval -0.084 to 0.115
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatmentPopulation: The Core Population with available data at baseline and each time point.
The EQ-5D-5L is a health state utility instrument that evaluates preference for health status with a separate visual analog scale (VAS). The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable).
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=44 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
|
|---|---|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
End of treatment
|
0.0 units on a scale
Interval -15.0 to 5.0
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
12 weeks after end of treatment
|
0.0 units on a scale
Interval -10.0 to 11.0
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
24 weeks after end of treatment
|
0.0 units on a scale
Interval -10.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatmentPopulation: The Core Population who were employed and with available data at baseline and each time point.
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Absenteeism indicates the percentage of work time missed due to health problems.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=17 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.
|
|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
End of treatment
|
0.0 percent impairment
Interval 0.0 to 0.0
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
12 weeks after end of treatment
|
0.0 percent impairment
Interval 0.0 to 0.0
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
24 weeks after end of treatment
|
0.0 percent impairment
Interval 0.0 to 42.9
|
Adverse Events
2 DAA
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
2 DAA + RBV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
3 DAA
Serious events: 2 serious events
Other events: 22 other events
Deaths: 1 deaths
3 DAA + RBV
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2 DAA
n=2 participants at risk
Participants received paritaprevir/ritonavir and ombitasvir for 12 weeks.
|
2 DAA + RBV
n=4 participants at risk
Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for 12 weeks.
|
3 DAA
n=34 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, dasabuvir, without ribavirin, for 12 weeks.
|
3 DAA + RBV
n=10 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir plus ribavirin for 12 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
2.9%
1/34 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/10 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
2.9%
1/34 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/10 • From first dose of study drug through 30 days after last dose (16 weeks).
|
Other adverse events
| Measure |
2 DAA
n=2 participants at risk
Participants received paritaprevir/ritonavir and ombitasvir for 12 weeks.
|
2 DAA + RBV
n=4 participants at risk
Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for 12 weeks.
|
3 DAA
n=34 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, dasabuvir, without ribavirin, for 12 weeks.
|
3 DAA + RBV
n=10 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir plus ribavirin for 12 weeks.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
5.9%
2/34 • Number of events 2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/10 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Nervous system disorders
HEADACHE
|
50.0%
1/2 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
17.6%
6/34 • Number of events 6 • From first dose of study drug through 30 days after last dose (16 weeks).
|
30.0%
3/10 • Number of events 3 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Psychiatric disorders
RESTLESSNESS
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
2.9%
1/34 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
40.0%
4/10 • Number of events 4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Renal and urinary disorders
NOCTURIA
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
20.0%
2/10 • Number of events 2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Skin and subcutaneous tissue disorders
DYSHIDROTIC ECZEMA
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
50.0%
1/2 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
8.8%
3/34 • Number of events 3 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
2.9%
1/34 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Eye disorders
EYE PAIN
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
5.9%
2/34 • Number of events 2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
8.8%
3/34 • Number of events 3 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/10 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
11.8%
4/34 • Number of events 4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/10 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
2.9%
1/34 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
17.6%
6/34 • Number of events 6 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/10 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
8.8%
3/34 • Number of events 3 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/10 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
General disorders
FATIGUE
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
35.3%
12/34 • Number of events 12 • From first dose of study drug through 30 days after last dose (16 weeks).
|
70.0%
7/10 • Number of events 7 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
General disorders
SENSE OF OPPRESSION
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
2.9%
1/34 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/10 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
2.9%
1/34 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/10 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/34 • From first dose of study drug through 30 days after last dose (16 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose of study drug through 30 days after last dose (16 weeks).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/4 • From first dose of study drug through 30 days after last dose (16 weeks).
|
5.9%
2/34 • Number of events 2 • From first dose of study drug through 30 days after last dose (16 weeks).
|
0.00%
0/10 • From first dose of study drug through 30 days after last dose (16 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER