Trial Outcomes & Findings for Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults (NCT NCT02476617)
NCT ID: NCT02476617
Last Updated: 2017-10-03
Results Overview
The changes from week 0 to post-treatment (PT) week 12 in key ISG expression in PBMCs for participants achieving sustained virologic response 12 weeks PT (SVR12) where SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\<LLOQ) 12 weeks after the last dose of study drug. For each key ISG, fold change was defined as the ratio of the difference between PT Week 12 and baseline expressions over the baseline expression.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
25 participants
Primary outcome timeframe
Week 0 to Post-Treatment Week 12
Results posted on
2017-10-03
Participant Flow
The intent-to-treat (ITT) population consisted of all enrolled participants who received at least one dose of study drug.
Participant milestones
| Measure |
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV
Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily \[QD\]) + dasabuvir (250 mg twice daily \[BID\]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
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|---|---|
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Overall Study
STARTED
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25
|
|
Overall Study
COMPLETED
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23
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Overall Study
NOT COMPLETED
|
2
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Reasons for withdrawal
| Measure |
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV
Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily \[QD\]) + dasabuvir (250 mg twice daily \[BID\]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
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|---|---|
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Overall Study
Adverse Event
|
1
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Overall Study
Lost to Follow-up
|
1
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Baseline Characteristics
Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults
Baseline characteristics by cohort
| Measure |
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV
n=25 Participants
Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg QD) + dasabuvir (250 mg BID) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
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|---|---|
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Age, Continuous
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44.8 years
STANDARD_DEVIATION 12.61 • n=5 Participants
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|
Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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19 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Week 0 to Post-Treatment Week 12Population: All participants who achieved SVR12 and had both baseline and post-baseline value at Post-Treatment Week 12 were included in this analyses..
The changes from week 0 to post-treatment (PT) week 12 in key ISG expression in PBMCs for participants achieving sustained virologic response 12 weeks PT (SVR12) where SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\<LLOQ) 12 weeks after the last dose of study drug. For each key ISG, fold change was defined as the ratio of the difference between PT Week 12 and baseline expressions over the baseline expression.
Outcome measures
| Measure |
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV
n=21 Participants
Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg QD) + dasabuvir (250 mg BID) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
|
|---|---|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
CXCL10
|
-0.464 Fold change
Standard Deviation 0.6143
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
ISG15
|
-0.148 Fold change
Standard Deviation 0.7458
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
CXCL11
|
-0.611 Fold change
Standard Deviation 0.3090
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
MX1
|
-0.399 Fold change
Standard Deviation 0.3013
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFI27
|
-0.462 Fold change
Standard Deviation 0.4624
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
OAS2
|
-0.168 Fold change
Standard Deviation 0.5168
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|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
DDX60
|
-0.016 Fold change
Standard Deviation 0.5696
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFIT3
|
-0.543 Fold change
Standard Deviation 0.3350
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFI44
|
-0.467 Fold change
Standard Deviation 0.2569
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
STAT1
|
-0.301 Fold change
Standard Deviation 0.3430
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
CXCL9
|
-0.552 Fold change
Standard Deviation 0.2816
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFIT1
|
-0.440 Fold change
Standard Deviation 0.4441
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
HERC5
|
-0.358 Fold change
Standard Deviation 0.2827
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IRF7
|
-0.171 Fold change
Standard Deviation 0.4273
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
OAS1
|
0.284 Fold change
Standard Deviation 1.4668
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
PLSCR1
|
-0.255 Fold change
Standard Deviation 0.3688
|
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Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IRF9
|
-0.205 Fold change
Standard Deviation 0.2809
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFIH1
|
-0.321 Fold change
Standard Deviation 0.3213
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
TRIM14
|
0.022 Fold change
Standard Deviation 0.5282
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IRF1
|
-0.130 Fold change
Standard Deviation 0.6497
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IRF3
|
0.044 Fold change
Standard Deviation 0.6307
|
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Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
STAT2
|
-0.051 Fold change
Standard Deviation 0.5762
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFNG
|
0.516 Fold change
Standard Deviation 1.4653
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|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFNL1
|
-0.361 Fold change
Standard Deviation 0.3753
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFNL2
|
-0.199 Fold change
Standard Deviation 0.7031
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFNL3
|
-0.205 Fold change
Standard Deviation 0.4306
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFNL4
|
-0.228 Fold change
Standard Deviation 0.7298
|
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Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFNGR1
|
-0.046 Fold change
Standard Deviation 0.3008
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Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
ADAR
|
-0.212 Fold change
Standard Deviation 0.2314
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|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
ALG10
|
-0.083 Fold change
Standard Deviation 0.7491
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|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
BCHE
|
-0.101 Fold change
Standard Deviation 0.5739
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
CCL2
|
0.200 Fold change
Standard Deviation 1.5071
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
CCL4
|
0.638 Fold change
Standard Deviation 1.7396
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
CD163
|
0.556 Fold change
Standard Deviation 2.7478
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
CXCL5
|
1.085 Fold change
Standard Deviation 2.7539
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|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
CXCR3
|
0.308 Fold change
Standard Deviation 0.5236
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|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
DDIT4
|
0.029 Fold change
Standard Deviation 1.2134
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
DDX58
|
0.388 Fold change
Standard Deviation 1.2231
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
DPP4
|
0.869 Fold change
Standard Deviation 1.5730
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
EIF2AK2
|
-0.317 Fold change
Standard Deviation 0.2521
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|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
GBP1
|
-0.288 Fold change
Standard Deviation 0.4421
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
GCKR
|
0.009 Fold change
Standard Deviation 0.5267
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
GUCY1B3
|
0.350 Fold change
Standard Deviation 0.7909
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|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
HELZ2
|
-0.232 Fold change
Standard Deviation 0.5124
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
HERC6
|
-0.074 Fold change
Standard Deviation 0.3294
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFI35
|
-0.023 Fold change
Standard Deviation 0.6428
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFI44L
|
-0.554 Fold change
Standard Deviation 0.4068
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFI6
|
-0.464 Fold change
Standard Deviation 0.3010
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFIT2
|
-0.365 Fold change
Standard Deviation 0.4118
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFIT5
|
-0.291 Fold change
Standard Deviation 0.2085
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFITM1
|
-0.066 Fold change
Standard Deviation 0.3696
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFITM2
|
0.158 Fold change
Standard Deviation 0.7905
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFITM3
|
-0.423 Fold change
Standard Deviation 0.3313
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFNA
|
-0.202 Fold change
Standard Deviation 0.5037
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IFNB
|
-0.167 Fold change
Standard Deviation 0.4427
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IL10
|
0.202 Fold change
Standard Deviation 0.8216
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IL18
|
-0.078 Fold change
Standard Deviation 0.2695
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
IRF2
|
0.311 Fold change
Standard Deviation 1.0487
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
ISG20
|
0.156 Fold change
Standard Deviation 1.0071
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
MAP3K14
|
-0.072 Fold change
Standard Deviation 0.2983
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
MOV10
|
-0.185 Fold change
Standard Deviation 0.4048
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
MS4A4A
|
-0.005 Fold change
Standard Deviation 0.7458
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
MX2
|
-0.101 Fold change
Standard Deviation 0.6188
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
MYST1
|
-0.057 Fold change
Standard Deviation 0.2404
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
NOS2A
|
0.249 Fold change
Standard Deviation 0.8288
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
NT5C3
|
0.017 Fold change
Standard Deviation 0.3577
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
OASL
|
-0.233 Fold change
Standard Deviation 0.6984
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
PPP3CB
|
0.011 Fold change
Standard Deviation 0.1956
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
RNASEL
|
0.395 Fold change
Standard Deviation 0.9973
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
RSAD2
|
-0.406 Fold change
Standard Deviation 0.3202
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
SLC27A2
|
0.022 Fold change
Standard Deviation 0.9149
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
SOCS1
|
1.313 Fold change
Standard Deviation 3.5778
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
SOCS3
|
0.025 Fold change
Standard Deviation 1.1773
|
|
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
USP18
|
-0.288 Fold change
Standard Deviation 0.3092
|
Adverse Events
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV
n=25 participants at risk
Arm/Group Description: Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg QD) + dasabuvir (250 mg BID) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
|
|---|---|
|
Injury, poisoning and procedural complications
OVERDOSE
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
ANXIETY
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
Other adverse events
| Measure |
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV
n=25 participants at risk
Arm/Group Description: Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg QD) + dasabuvir (250 mg BID) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
|
|---|---|
|
Ear and labyrinth disorders
EXCESSIVE CERUMEN PRODUCTION
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Ear and labyrinth disorders
VERTIGO
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
12.0%
3/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
CONSTIPATION
|
16.0%
4/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
DIARRHOEA
|
20.0%
5/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
16.0%
4/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
ERUCTATION
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
8.0%
2/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
NAUSEA
|
36.0%
9/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
RETCHING
|
8.0%
2/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
VOMITING
|
12.0%
3/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
ASTHENIA
|
12.0%
3/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
CHEST DISCOMFORT
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
CHEST PAIN
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
CYST
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
FATIGUE
|
64.0%
16/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
FEELING JITTERY
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
MALAISE
|
12.0%
3/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
PAIN
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
PERIPHERAL SWELLING
|
8.0%
2/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
BILIARY DILATATION
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Immune system disorders
HYPERSENSITIVITY
|
8.0%
2/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
BRONCHITIS
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
EAR INFECTION
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
8.0%
2/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
HERPES ZOSTER
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
INFECTED DERMAL CYST
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
INFLUENZA
|
8.0%
2/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
NASOPHARYNGITIS
|
12.0%
3/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
SINUSITIS
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
TOOTH INFECTION
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
16.0%
4/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
CREATININE RENAL CLEARANCE DECREASED
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
HAEMATOCRIT DECREASED
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
16.0%
4/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
12.0%
3/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
8.0%
2/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
12.0%
3/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
BURNING SENSATION
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
DIZZINESS
|
16.0%
4/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
DYSGEUSIA
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
HEADACHE
|
24.0%
6/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
HYPOAESTHESIA
|
8.0%
2/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
PARAESTHESIA
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
POOR QUALITY SLEEP
|
8.0%
2/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
8.0%
2/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
SYNCOPE
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
ANXIETY
|
16.0%
4/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
DEPRESSION
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
INSOMNIA
|
24.0%
6/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
IRRITABILITY
|
16.0%
4/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
MOOD SWINGS
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
TACHYPHRENIA
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Renal and urinary disorders
CHROMATURIA
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
16.0%
4/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
8.0%
2/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
12.0%
3/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
RASH
|
12.0%
3/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
SKIN IRRITATION
|
4.0%
1/25 • Treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
Additional Information
Global Medical Services
AbbVie
Phone: 800-633-9110
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