Trial Outcomes & Findings for The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France (NCT NCT02618928)
NCT ID: NCT02618928
Last Updated: 2019-06-17
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
735 participants
Primary outcome timeframe
12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)
Results posted on
2019-06-17
Participant Flow
This observational study was conducted in 69 medical centers in France experienced in the treatment of chronic hepatitis C (CHC). The first participant entered the study on 15 December 2015, last patient last visit was on 29 March 2018.
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 8, 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, and 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
|
735
|
|
Overall Study
Received Treatment
|
728
|
|
Overall Study
COMPLETED
|
677
|
|
Overall Study
NOT COMPLETED
|
58
|
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 8, 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, and was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.
|
|---|---|
|
Overall Study
Failure to Return
|
28
|
|
Overall Study
Insufficient Virological Response
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Death
|
3
|
|
Overall Study
Other
|
11
|
|
Overall Study
Missing
|
6
|
|
Overall Study
Treatment Never Started
|
7
|
Baseline Characteristics
The core population included all 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).
Baseline characteristics by cohort
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=728 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Pretreatment Status
Experienced
|
238 Participants
n=728 Participants
|
|
Pretreatment Status
Missing
|
1 Participants
n=728 Participants
|
|
HCV RNA Concentration
|
6.13 log10 IU/mL
n=720 Participants • The core population included all 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).
|
|
Assigned Treatment Regimen
2 DAA without RBV for 12 weeks
|
4 Participants
n=728 Participants
|
|
Assigned Treatment Regimen
2 DAA with RBV for 12 weeks
|
209 Participants
n=728 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 12.1 • n=728 Participants
|
|
Age, Customized
18 to 65 years
|
570 Participants
n=728 Participants
|
|
Age, Customized
66 to 84 years
|
151 Participants
n=728 Participants
|
|
Age, Customized
85 years or older
|
7 Participants
n=728 Participants
|
|
Sex: Female, Male
Female
|
372 Participants
n=728 Participants
|
|
Sex: Female, Male
Male
|
356 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
White
|
577 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
Black
|
90 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
Asian
|
28 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
Other
|
32 Participants
n=728 Participants
|
|
Years Since Diagnosis of HCV Infection
|
13.8 years
STANDARD_DEVIATION 10.57 • n=728 Participants
|
|
HCV Genotype
Genotype 1a
|
78 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 1a/1b
|
3 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 1b
|
427 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 1d
|
1 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 1e
|
2 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 1l
|
1 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 1, subtype unknown
|
1 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 1/4, subtype unknown
|
1 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 4a
|
39 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 4a/4c/4d
|
11 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 4c
|
3 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 4c/4d
|
5 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 4d
|
14 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 4e
|
2 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 4f
|
7 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 4h
|
1 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 4k
|
1 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 4r
|
2 Participants
n=728 Participants
|
|
HCV Genotype
Genotype 4, subtype unknown
|
129 Participants
n=728 Participants
|
|
Cirrhosis Status
No cirrhosis
|
520 Participants
n=728 Participants
|
|
Cirrhosis Status
Transition to cirrhosis
|
97 Participants
n=728 Participants
|
|
Cirrhosis Status
Cirrhosis
|
111 Participants
n=728 Participants
|
|
Pretreatment Status
Naive
|
489 Participants
n=728 Participants
|
|
Assigned Treatment Regimen
3 DAA without RBV for 8 weeks
|
95 Participants
n=728 Participants
|
|
Assigned Treatment Regimen
3 DAA without RBV for 12 weeks
|
334 Participants
n=728 Participants
|
|
Assigned Treatment Regimen
3 DAA with RBV for 12 weeks
|
84 Participants
n=728 Participants
|
|
Assigned Treatment Regimen
3 DAA with RBV for 24 weeks
|
2 Participants
n=728 Participants
|
|
Co-morbidities
Any co-morbidity or co-infection
|
387 Participants
n=728 Participants
|
|
Co-morbidities
Human immunodeficiency virus (HIV) co-infection
|
13 Participants
n=728 Participants
|
|
Co-morbidities
Hepatitis B co-infection
|
7 Participants
n=728 Participants
|
|
Co-morbidities
Tuberculosis co-infection
|
1 Participants
n=728 Participants
|
|
Drug Users
Psychoactive drug dependency
|
45 Participants
n=728 Participants
|
|
Drug Users
Active injection drug use
|
5 Participants
n=728 Participants
|
|
Drug Users
Opiate substitution
|
33 Participants
n=728 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)Population: The Core population includes 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=720 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
|
90.7 percentage of participants
Interval 88.4 to 92.6
|
SECONDARY outcome
Timeframe: End of treatment (week 8, 12, or 24 depending on the treatment regimen)Population: The Core population includes 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=720 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Percentage of Participants Achieving Virological Response at End of Treatment
|
94.4 percentage of participants
Interval 92.5 to 95.9
|
SECONDARY outcome
Timeframe: 12 weeks after the last dose of study drug (week 20, 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=684 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment
|
95.5 percentage of participants
Interval 93.6 to 96.8
|
SECONDARY outcome
Timeframe: End of treatment (week 8, 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, 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=648 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Percentage of Participants With Relapse
|
1.2 percentage of participants
Interval 0.6 to 2.4
|
SECONDARY outcome
Timeframe: 8, 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=404 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Percentage of Participants With Breakthrough
|
0.5 percentage of participants
Interval 0.1 to 1.8
|
SECONDARY outcome
Timeframe: Week 4Population: The Core population includes 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).
RVR 4 was defined as participants with HCV RNA \< 50 IU/mL at week 4.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=720 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)
|
49.0 percentage of participants
Interval 45.4 to 52.7
|
SECONDARY outcome
Timeframe: 24 weeks after the last dose of study drug (week 32, 36, or 48 depending on the treatment regimen)Population: The Core population with sufficient follow-up data regarding SVR24
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug. The Core population with sufficient follow-up data regarding SVR24 included all core population participants who * had evaluable HCV RNA data ≥ 126 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 ≥ 126 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=616 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)
|
94.8 percentage of participants
Interval 92.8 to 96.3
|
SECONDARY outcome
Timeframe: 12 weeks after the last dose of study drug (week 20, 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); * Death * Premature treatment discontinuation with no on-treatment virologic failure; * Insufficient virological response reported or HCV RNA ≥ 50 IU/mL post-EOT and none of the above criteria * Missing SVR12 data and/or none of the above criteria.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=720 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Number of Participants in Each Non-response Category 12 Weeks Post-treatment
On-treatment virological failure
|
11 Participants
|
|
Number of Participants in Each Non-response Category 12 Weeks Post-treatment
Relapse
|
7 Participants
|
|
Number of Participants in Each Non-response Category 12 Weeks Post-treatment
Death
|
2 Participants
|
|
Number of Participants in Each Non-response Category 12 Weeks Post-treatment
Premature treatment discontinuation
|
14 Participants
|
|
Number of Participants in Each Non-response Category 12 Weeks Post-treatment
Insufficient virological response reported
|
3 Participants
|
|
Number of Participants in Each Non-response Category 12 Weeks Post-treatment
Missing/none of the above
|
30 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.Population: Core population
Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration) \* 100 The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=720 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category
> 105%
|
38 Participants
|
|
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category
> 95% to ≤ 105%
|
623 Participants
|
|
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category
> 80% to ≤ 95%
|
19 Participants
|
|
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category
> 50% to ≤ 80%
|
15 Participants
|
|
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category
≤ 50%
|
15 Participants
|
|
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category
Missing
|
10 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.Population: Core population who were prescribed ribavirin
Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration) \* 100
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=292 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Percentage of Participants With Adherence to Ribavirin by Adherence Category
> 105%
|
22 Participants
|
|
Percentage of Participants With Adherence to Ribavirin by Adherence Category
> 95% to ≤ 105%
|
219 Participants
|
|
Percentage of Participants With Adherence to Ribavirin by Adherence Category
> 80% to ≤ 95%
|
20 Participants
|
|
Percentage of Participants With Adherence to Ribavirin by Adherence Category
> 50% to ≤ 80%
|
15 Participants
|
|
Percentage of Participants With Adherence to Ribavirin by Adherence Category
≤ 50%
|
10 Participants
|
|
Percentage of Participants With Adherence to Ribavirin by Adherence Category
Missing
|
6 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.Population: Core population who were prescribed ribavirin and with non-missing data
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=288 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days
|
98.5 percentage of days
Standard Deviation 13.96
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimenPopulation: All treated participants
Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=728 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Number of Participants Who Received Concomitant Medications
Any co-medication
|
351 Participants
|
|
Number of Participants Who Received Concomitant Medications
Beta blocking agents
|
60 Participants
|
|
Number of Participants Who Received Concomitant Medications
Analgesics
|
58 Participants
|
|
Number of Participants Who Received Concomitant Medications
Thyroid therapy
|
46 Participants
|
|
Number of Participants Who Received Concomitant Medications
Peptic ulcer / gastro-oesophageal reflux disease
|
45 Participants
|
|
Number of Participants Who Received Concomitant Medications
Benzodiazepine derivatives
|
40 Participants
|
|
Number of Participants Who Received Concomitant Medications
ACE inhibitors
|
39 Participants
|
|
Number of Participants Who Received Concomitant Medications
Diuretics
|
37 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.Population: All treated participants
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=728 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Any adverse event
|
163 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Serious adverse event
|
20 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Pregnancy
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatmentPopulation: Core population with non-missing data at baseline and each time point
The Fatigue Impact Scale (FIS) questionnaire was used to assess the impact of fatigue on the quality of life of patients. The FIS consists of 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a total score from of 0 to 160, where a lower score = less fatigue impact
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=629 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Change From Baseline in Fatigue Impact Scale Total Score
End of treatment
|
-6.78 units on a scale
Standard Deviation 31.80
|
|
Change From Baseline in Fatigue Impact Scale Total Score
12 weeks after end of treatment
|
-18.27 units on a scale
Standard Deviation 32.06
|
|
Change From Baseline in Fatigue Impact Scale Total Score
24 weeks after end of treatment
|
-16.75 units on a scale
Standard Deviation 32.34
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatmentPopulation: 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=604 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
End of treatment
|
0.044 units on a scale
Standard Deviation 0.208
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
12 weeks after end of treatment
|
0.088 units on a scale
Standard Deviation 0.202
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
24 weeks after end of treatment
|
0.087 units on a scale
Standard Deviation 0.196
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatmentPopulation: 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=630 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
End of treatment
|
6.8 units on a scale
Standard Deviation 18.92
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
12 weeks after end of treatment
|
10.6 units on a scale
Standard Deviation 17.60
|
|
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
24 weeks after end of treatment
|
10.4 units on a scale
Standard Deviation 17.70
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 8, 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=258 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
End of treatment
|
5.2 percent impairment
Standard Deviation 24.2
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
12 weeks after end of treatment
|
0.4 percent impairment
Standard Deviation 20.5
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
24 weeks after end of treatment
|
-1.5 percent impairment
Standard Deviation 16.8
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 8, 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. Presenteeism indicates the percentage of impairment while working due to health problems.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=259 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
End of treatment
|
-1.2 percent impairment
Standard Deviation 28.0
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
12 weeks after end of treatment
|
-5.5 percent impairment
Standard Deviation 25.2
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
24 weeks after end of treatment
|
-7.4 percent impairment
Standard Deviation 22.9
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 8, 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. Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=253 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
End of treatment
|
1.3 percent impairment
Standard Deviation 33.6
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
12 weeks after end of treatment
|
-4.9 percent impairment
Standard Deviation 30.1
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
24 weeks after end of treatment
|
-8.7 percent impairment
Standard Deviation 25.4
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 8, 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 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. Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=615 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
End of treatment
|
1.6 percent impairment
Standard Deviation 33.0
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
12 weeks after end of treatment
|
-7.2 percent impairment
Standard Deviation 32.8
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
24 weeks after end of treatment
|
-9.5 percent impairment
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)Population: The Core population with available data at baseline and end of treatment.
The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=720 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)
Specific Concerns
|
-0.100 units on a scale
Standard Deviation 0.871
|
|
Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)
Specific Necessity
|
-0.099 units on a scale
Standard Deviation 0.739
|
|
Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)
General Overuse
|
0.119 units on a scale
Standard Deviation 0.685
|
|
Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)
General Harm
|
0.135 units on a scale
Standard Deviation 0.670
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)Population: The Core population with available data at baseline and end of treatment.
PAM 13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating higher patient activation.
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=433 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Change From Baseline in Patient Activation Measure 13 (PAM-13)
|
0.44 units on a scale
Standard Deviation 9.43
|
SECONDARY outcome
Timeframe: From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.Population: Core population with available data
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=694 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Number of Participants With Outpatient Consultations Due to Liver Disease by Category
No outpatient consultations
|
515 Participants
|
|
Number of Participants With Outpatient Consultations Due to Liver Disease by Category
One outpatient consultation
|
80 Participants
|
|
Number of Participants With Outpatient Consultations Due to Liver Disease by Category
Two or three outpatient consultations
|
94 Participants
|
|
Number of Participants With Outpatient Consultations Due to Liver Disease by Category
Four or more outpatient consultations
|
5 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.Population: Core population with available data
Outcome measures
| Measure |
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
n=694 Participants
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 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.
|
|---|---|
|
Number of Participants With Hospitalizations Due to Liver Disease by Category
No hospitalizations
|
685 Participants
|
|
Number of Participants With Hospitalizations Due to Liver Disease by Category
One hospitalization
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)Population: Treated participants with available data at baseline and end of treatment.
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 8, 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.
|
|---|---|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
|
-7.07 percent glycosylated hemoglobin
Standard Deviation 10.70
|
Adverse Events
Paritaprevir/Ritonavir + Ombitasvir Without RBV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Paritaprevir/Ritonavir + Ombitasvir With RBV
Serious events: 1 serious events
Other events: 33 other events
Deaths: 5 deaths
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV
Serious events: 13 serious events
Other events: 38 other events
Deaths: 1 deaths
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
Serious events: 6 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Paritaprevir/Ritonavir + Ombitasvir Without RBV
n=4 participants at risk
Participants received paritaprevir/ritonavir and ombitasvir without ribavirin for either 12 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir With RBV
n=209 participants at risk
Participants received paritaprevir/ritonavir and ombitasvir with ribavirin for either 12 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV
n=429 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 8 or 12 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
n=86 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.48%
1/209 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/429 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.47%
2/429 • Number of events 2 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/429 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
1.2%
1/86 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.23%
1/429 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/429 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
1.2%
1/86 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.23%
1/429 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
General disorders
PYREXIA
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.48%
1/209 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/429 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.47%
2/429 • Number of events 2 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/429 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
1.2%
1/86 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.23%
1/429 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.23%
1/429 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.23%
1/429 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Investigations
PROTHROMBIN TIME PROLONGED
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.23%
1/429 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.23%
1/429 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Metabolism and nutrition disorders
FOOD INTOLERANCE
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.23%
1/429 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC CANCER
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.23%
1/429 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Nervous system disorders
CAROTID ANEURYSM RUPTURE
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/429 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
1.2%
1/86 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/429 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
1.2%
1/86 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/429 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
1.2%
1/86 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Psychiatric disorders
HYPOMANIA
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.23%
1/429 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/86 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
Other adverse events
| Measure |
Paritaprevir/Ritonavir + Ombitasvir Without RBV
n=4 participants at risk
Participants received paritaprevir/ritonavir and ombitasvir without ribavirin for either 12 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir With RBV
n=209 participants at risk
Participants received paritaprevir/ritonavir and ombitasvir with ribavirin for either 12 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV
n=429 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 8 or 12 weeks.
|
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV
n=86 participants at risk
Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
10.5%
22/209 • Number of events 22 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/429 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
4.7%
4/86 • Number of events 4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
General disorders
ASTHENIA
|
0.00%
0/4 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
2.9%
6/209 • Number of events 6 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
6.1%
26/429 • Number of events 26 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
8.1%
7/86 • Number of events 7 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
General disorders
FATIGUE
|
25.0%
1/4 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
3.8%
8/209 • Number of events 8 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
2.8%
12/429 • Number of events 12 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
1.2%
1/86 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
25.0%
1/4 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/209 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
0.00%
0/429 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
1.2%
1/86 • Number of events 1 • Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
|
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