Trial Outcomes & Findings for Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea (NCT NCT03572972)
NCT ID: NCT03572972
Last Updated: 2023-04-06
Results Overview
Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.
COMPLETED
64684 participants
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
2023-04-06
Participant Flow
Data was retrieved from Korean Health Insurance Review \& Assessment Service (HIRA) database, of participants who were diagnosed with non-valvular atrial fibrillation (NVAF) from 1-January-2007 up to and including index date, who newly initiated non-vitamin K antagonist oral anticoagulants (NOACs), warfarin or used aspirin during intake duration.
It is a retrospective, observational study. Index date: first prescription date of study drugs during intake duration. Intake period: between 1-July-2015 to 30-November-2016. Inverse probability of treatment weighted (IPTW) method was used to analyze outcome measures to balance participant's characteristics among reporting arms.
Participant milestones
| Measure |
NOAC - Apixaban
Oral anticoagulants (OACs) treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for apixaban was defined as the first prescription date of apixaban during the intake period from 1-July-2015 to 30-November-2016.
|
NOAC - Dabigatran
OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for dabigatran was defined as the first prescription date of dabigatran during the intake period from 1-July-2015 to 30-November-2016.
|
NOAC - Rivaroxaban
OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for rivaroxaban was defined as the first prescription date of rivaroxaban during the intake period from 1-July-2015 to 30-November-2016.
|
Warfarin
OACs treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for warfarin was defined as the first prescription date of warfarin during the intake period from 1-July-2015 to 30-November-2016.
|
Aspirin
OACs treatment-naive participants diagnosed with NVAF, who initiated aspirin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for aspirin was defined as the first prescription date of aspirin during the intake period from 1-July-2015 to 30-November-2016.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10548
|
11414
|
17779
|
8648
|
16295
|
|
Overall Study
COMPLETED
|
10548
|
11414
|
17779
|
8648
|
16295
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
NOAC - Apixaban
n=10548 Participants
Oral anticoagulants (OACs) treatment-naive participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for apixaban was defined as the first prescription date of apixaban during the intake period from 1-July-2015 to 30-November-2016.
|
NOAC - Dabigatran
n=11414 Participants
OACs treatment-naive participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for dabigatran was defined as the first prescription date of dabigatran during the intake period from 1-July-2015 to 30-November-2016.
|
NOAC - Rivaroxaban
n=17779 Participants
OACs treatment-naive participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for rivaroxaban was defined as the first prescription date of rivaroxaban during the intake period from 1-July-2015 to 30-November-2016.
|
Warfarin
n=8648 Participants
OACs treatment-naive participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for warfarin was defined as the first prescription date of warfarin during the intake period from 1-July-2015 to 30-November-2016.
|
Aspirin
n=16295 Participants
OACs treatment-naive participants diagnosed with NVAF, who initiated aspirin on the index date, were included in this study cohort and their data available in Korean HIRA database was retrospectively observed. Index date for aspirin was defined as the first prescription date of aspirin during the intake period from 1-July-2015 to 30-November-2016.
|
Total
n=64684 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
73.89 years
STANDARD_DEVIATION 9.52 • n=10548 Participants
|
72.23 years
STANDARD_DEVIATION 9.52 • n=11414 Participants
|
73.27 years
STANDARD_DEVIATION 9.55 • n=17779 Participants
|
68.73 years
STANDARD_DEVIATION 12.62 • n=8648 Participants
|
72.10 years
STANDARD_DEVIATION 9.17 • n=16295 Participants
|
72.29 years
STANDARD_DEVIATION 10.04 • n=64684 Participants
|
|
Sex: Female, Male
Female
|
5148 Participants
n=10548 Participants
|
4926 Participants
n=11414 Participants
|
8169 Participants
n=17779 Participants
|
3238 Participants
n=8648 Participants
|
6995 Participants
n=16295 Participants
|
28476 Participants
n=64684 Participants
|
|
Sex: Female, Male
Male
|
5400 Participants
n=10548 Participants
|
6488 Participants
n=11414 Participants
|
9610 Participants
n=17779 Participants
|
5410 Participants
n=8648 Participants
|
9300 Participants
n=16295 Participants
|
36208 Participants
n=64684 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10514 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=8677 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=8676 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=17780 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=8638 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
|
7.66 events per 100 participants-years
|
13.52 events per 100 participants-years
|
7.2 events per 100 participants-years
|
13.53 events per 100 participants-years
|
7.18 events per 100 participants-years
|
12.89 events per 100 participants-years
|
PRIMARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10567 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=10545 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=17812 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=11416 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=17801 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
|
7.75 events per 100 participants-years
|
7.47 events per 100 participants-years
|
7.35 events per 100 participants-years
|
7.48 events per 100 participants-years
|
7.01 events per 100 participants-years
|
7.31 events per 100 participants-years
|
PRIMARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate: number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62,H448,H3572,H356,H313,H210,H113,H052,H470,H431,I312,N020-N029,N421,N831,N857,N920,N923,N930,N938-939,M250,R233,R040-042,R048-049,T792,T810,N950,R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date= first prescription date of study drugs during intake duration. Participants were identified as NOAC user/Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10514 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=8677 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=8676 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=17780 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=8638 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
|
7.97 events per 100 participants-years
|
14.73 events per 100 participants-years
|
8.57 events per 100 participants-years
|
13.77 events per 100 participants-years
|
9.55 events per 100 participants-years
|
14.23 events per 100 participants-years
|
PRIMARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938-939, M250, R233, R040-042, R048-049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date = the first prescription date of study drugs during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10567 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=10545 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=17812 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=11416 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=17801 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
|
7.70 events per 100 participants-years
|
8.65 events per 100 participants-years
|
7.77 events per 100 participants-years
|
9.86 events per 100 participants-years
|
8.18 events per 100 participants-years
|
9.36 events per 100 participants-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10514 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=8677 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=8676 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=17780 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=8638 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
|
1.1 events per 100 participants-years
|
1.73 events per 100 participants-years
|
0.78 events per 100 participants-years
|
1.71 events per 100 participants-years
|
1.18 events per 100 participants-years
|
1.72 events per 100 participants-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10567 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=10545 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=17812 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=11416 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=17801 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
|
1.11 events per 100 participants-years
|
0.74 events per 100 participants-years
|
1.05 events per 100 participants-years
|
1.15 events per 100 participants-years
|
0.71 events per 100 participants-years
|
1.14 events per 100 participants-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10514 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=8677 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=8676 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=17780 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=8638 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
|
6.9 events per 100 participants-years
|
11.8 events per 100 participants-years
|
6.53 events per 100 participants-years
|
11.92 events per 100 participants-years
|
6.29 events per 100 participants-years
|
11.19 events per 100 participants-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10567 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=10545 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=17812 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=11416 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=17801 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
|
6.99 events per 100 participants-years
|
6.84 events per 100 participants-years
|
6.60 events per 100 participants-years
|
6.58 events per 100 participants-years
|
6.37 events per 100 participants-years
|
6.43 events per 100 participants-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10514 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=8677 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=8676 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=17780 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=8638 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
|
0.18 events per 100 participants-years
|
0.78 events per 100 participants-years
|
0.24 events per 100 participants-years
|
0.75 events per 100 participants-years
|
0.27 events per 100 participants-years
|
0.74 events per 100 participants-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date= the first prescription date of study drugs during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10567 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=10545 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=17812 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=11416 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=17801 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
|
0.20 events per 100 participants-years
|
0.25 events per 100 participants-years
|
0.20 events per 100 participants-years
|
0.28 events per 100 participants-years
|
0.24 events per 100 participants-years
|
0.26 events per 100 participants-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10514 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=8677 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=8676 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=17780 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=8638 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
|
3.44 events per 100 participants-years
|
6.2 events per 100 participants-years
|
4.17 events per 100 participants-years
|
5.56 events per 100 participants-years
|
4.32 events per 100 participants-years
|
5.78 events per 100 participants-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10567 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=10545 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=17812 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=11416 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=17801 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
|
3.23 events per 100 participants-years
|
4.18 events per 100 participants-years
|
3.28 events per 100 participants-years
|
4.59 events per 100 participants-years
|
3.97 events per 100 participants-years
|
4.25 events per 100 participants-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10514 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=8677 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=8676 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=17780 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=8638 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis
|
1.37 events per 100 participants-years
|
2.38 events per 100 participants-years
|
1.17 events per 100 participants-years
|
2.31 events per 100 participants-years
|
1.47 events per 100 participants-years
|
2.37 events per 100 participants-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10567 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=10545 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=17812 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=11416 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=17801 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis
|
1.39 events per 100 participants-years
|
1.12 events per 100 participants-years
|
1.35 events per 100 participants-years
|
1.43 events per 100 participants-years
|
1.08 events per 100 participants-years
|
1.41 events per 100 participants-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10514 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=8677 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=8676 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=17780 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=8638 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
|
3.75 events per 100 participants-years
|
6.93 events per 100 participants-years
|
3.86 events per 100 participants-years
|
6.61 events per 100 participants-years
|
4.42 events per 100 participants-years
|
6.85 events per 100 participants-years
|
SECONDARY outcome
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)Population: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.
Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration.
Outcome measures
| Measure |
Apixaban vs Warfarin (Apixaban)
n=10514 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of apixaban and matched on propensity scores with warfarin using inverse probability of treatment weighting (IPTW).
|
Apixaban vs Warfarin (Warfarin)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with apixaban using IPTW.
|
Dabigatran vs Warfarin (Dabigatran)
n=10514 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of dabigatran and matched on propensity scores with warfarin using IPTW.
|
Dabigatran vs Warfarin (Warfarin)
n=17780 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with dabigatran using IPTW.
|
Rivaroxaban vs Warfarin (Rivaroxaban)
n=11415 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of rivaroxaban and matched on propensity scores with warfarin using IPTW.
|
Rivaroxaban vs Warfarin (Warfarin)
n=17779 Participants
OACs treatment-naive participants diagnosed with NVAF, with index treatment of warfarin and matched on propensity scores with rivaroxaban using IPTW.
|
|---|---|---|---|---|---|---|
|
Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
|
3.67 events per 100 participants-years
|
4.06 events per 100 participants-years
|
3.73 events per 100 participants-years
|
4.54 events per 100 participants-years
|
3.83 events per 100 participants-years
|
4.35 events per 100 participants-years
|
Adverse Events
NOAC - Apixaban
NOAC - Dabigatran
NOAC - Rivaroxaban
Warfarin
Aspirin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER