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Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf) (SPAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03441633
Recruitment Status : Completed
First Posted : February 22, 2018
Results First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Atrial Fibrillation
Interventions Drug: apixaban
Drug: dabigatran
Drug: VKA
Drug: rivaroxaban
Enrollment 51690
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Hide Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Period Title: Overall Study
Started 4712 1423 32212 192 2286 363 2855 953 5132 1562
Completed 4712 1423 32212 192 2286 363 2855 953 5132 1562
Not Completed 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive Total
Hide Arm/Group Description Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician. Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with warfarin with prior prescription of different VKA, apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician. Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician. Total of all reporting groups
Overall Number of Baseline Participants 4712 1423 32212 192 2286 363 2855 953 5132 1562 51690
Hide Baseline Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for stroke prevention in atrial fibrillation(SPAF) registered in information system for the improvement of research in primary care(SIDIAP) database during the study and diagnosed with non-valvular atrial fibrillation(NVAF).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4712 participants 1423 participants 32212 participants 192 participants 2286 participants 363 participants 2855 participants 953 participants 5132 participants 1562 participants 51690 participants
71.8  (11.1) 78.1  (8.7) 73.5  (12.3) 74.6  (10.7) 69.7  (13.4) 74.9  (12.9) 69.9  (12.3) 76.5  (9.5) 69.3  (13.2) 76.4  (10.5) 72.8  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4712 participants 1423 participants 32212 participants 192 participants 2286 participants 363 participants 2855 participants 953 participants 5132 participants 1562 participants 51690 participants
Female
2661
  56.5%
751
  52.8%
15531
  48.2%
94
  49.0%
979
  42.8%
205
  56.5%
1399
  49.0%
479
  50.3%
2649
  51.6%
811
  51.9%
25559
  49.4%
Male
2051
  43.5%
672
  47.2%
16681
  51.8%
98
  51.0%
1307
  57.2%
158
  43.5%
1456
  51.0%
474
  49.7%
2483
  48.4%
751
  48.1%
26131
  50.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Participants by Their Sociodemographic Characteristics: Smoking Habit
Hide Description Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Hide Arm/Group Description:
Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.
Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Overall Number of Participants Analyzed 4712 1423 32212 192 2286 363 2855 953 5132 1562
Measure Type: Count of Participants
Unit of Measure: Participants
Missing
207
   4.4%
23
   1.6%
1844
   5.7%
7
   3.6%
112
   4.9%
14
   3.9%
225
   7.9%
23
   2.4%
354
   6.9%
38
   2.4%
Non-smoker
3104
  65.9%
946
  66.5%
19440
  60.4%
119
  62.0%
1166
  51.0%
234
  64.5%
1684
  59.0%
623
  65.4%
3079
  60.0%
1030
  65.9%
Ex-smoker
459
   9.7%
83
   5.8%
3676
  11.4%
16
   8.3%
320
  14.0%
26
   7.2%
355
  12.4%
72
   7.6%
608
  11.8%
102
   6.5%
Smoker
942
  20.0%
371
  26.1%
7252
  22.5%
50
  26.0%
688
  30.1%
89
  24.5%
591
  20.7%
235
  24.7%
1091
  21.3%
392
  25.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.68 to 0.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
1.14 to 1.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.93 to 1.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.755
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.80 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.426
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
0.95 to 1.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.930
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.77 to 1.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.72 to 0.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
1.10 to 1.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.98 to 1.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.755
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.84 to 1.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.426
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.84 to 1.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.930
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.81 to 1.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.74 to 0.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
1.08 to 1.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
1.08 to 1.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.755
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.60 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.426
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.48
Confidence Interval (2-Sided) 95%
0.82 to 2.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.930
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.70 to 1.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.49 to 0.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
1.29 to 1.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.72
Confidence Interval (2-Sided) 95%
1.54 to 1.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Non-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.755
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.72 to 1.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Ex-smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.426
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.78 to 1.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in naive participants (Smoker)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.930
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.70 to 1.20
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit
Hide Description Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Hide Arm/Group Description:
Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.
Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Overall Number of Participants Analyzed 4712 1423 32212 192 2286 363 2855 953 5132 1562
Measure Type: Count of Participants
Unit of Measure: Participants
Missing
2162
  45.9%
353
  24.8%
11299
  35.1%
40
  20.8%
839
  36.7%
91
  25.1%
1263
  44.2%
211
  22.1%
2475
  48.2%
366
  23.4%
No intake
1749
  37.1%
810
  56.9%
14337
  44.5%
111
  57.8%
984
  43.0%
212
  58.4%
1054
  36.9%
550
  57.7%
1696
  33.0%
923
  59.1%
Moderate intake
765
  16.2%
247
  17.4%
6241
  19.4%
39
  20.3%
447
  19.6%
58
  16.0%
505
  17.7%
187
  19.6%
915
  17.8%
255
  16.3%
Risk consumption
36
   0.8%
13
   0.9%
335
   1.0%
2
   1.0%
16
   0.7%
2
   0.6%
33
   1.2%
5
   0.5%
46
   0.9%
18
   1.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (No intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.90 to 1.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.98 to 1.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.52
Confidence Interval (2-Sided) 95%
0.94 to 2.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (No intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.826
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.87 to 1.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.190
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.94 to 1.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.526
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.18 to 1.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (No intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.77 to 0.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
1.01 to 1.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.76 to 1.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (No intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.826
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.95 to 1.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.190
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.77 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.526
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.62 to 2.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (No intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
1.28 to 1.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
1.14 to 1.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.98 to 1.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (No intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.826
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.76 to 1.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.190
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.82 to 1.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.526
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.17 to 4.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (No intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
1.16 to 1.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
1.10 to 1.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.49 to 1.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (No intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.826
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.84 to 1.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Moderate intake)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.190
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.66 to 1.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Risk consumption)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.526
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.09 to 2.36
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants by Their Sociodemographic Characteristics: MEDEA
Hide Description Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included MEDEA. MEDEA was a deprivation index that was associated with overall mortality in urban areas. It included factors like job, education, housing conditions and single parent homes. The MEDEA index was categorized in quintiles for urban areas, with quintile 1 corresponding to the least deprived population and quintile 5, the most deprived.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here, "Overall Number of Participants Analyzed (N)" signifies participants who were evaluable for this outcome measure.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Hide Arm/Group Description:
Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.
Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Overall Number of Participants Analyzed 4027 1210 25477 154 2163 322 2393 789 4430 1389
Measure Type: Count of Participants
Unit of Measure: Participants
Missing - Urban area
190
   4.7%
90
   7.4%
1754
   6.9%
16
  10.4%
120
   5.5%
28
   8.7%
110
   4.6%
57
   7.2%
230
   5.2%
145
  10.4%
Quintile 1 - Urban area
716
  17.8%
224
  18.5%
4735
  18.6%
31
  20.1%
149
   6.9%
73
  22.7%
558
  23.3%
156
  19.8%
973
  22.0%
230
  16.6%
Quintile 2 - Urban area
754
  18.7%
216
  17.9%
4753
  18.7%
25
  16.2%
315
  14.6%
73
  22.7%
461
  19.3%
148
  18.8%
803
  18.1%
234
  16.8%
Quintile 3 - Urban area
825
  20.5%
256
  21.2%
4801
  18.8%
27
  17.5%
606
  28.0%
52
  16.1%
447
  18.7%
137
  17.4%
904
  20.4%
230
  16.6%
Quintile 4 - Urban area
807
  20.0%
231
  19.1%
4744
  18.6%
28
  18.2%
635
  29.4%
55
  17.1%
429
  17.9%
152
  19.3%
837
  18.9%
300
  21.6%
Quintile 5 - Urban area
735
  18.3%
193
  16.0%
4690
  18.4%
27
  17.5%
338
  15.6%
41
  12.7%
388
  16.2%
139
  17.6%
683
  15.4%
250
  18.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
1.20 to 1.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.89 to 1.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.77 to 0.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.75 to 0.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.74 to 0.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.157
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.84 to 1.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.82 to 1.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.61 to 0.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.78 to 1.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.86 to 1.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
1.17 to 1.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.87 to 1.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.91 to 1.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.85 to 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.74 to 0.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.157
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.76 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.81 to 1.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.65 to 0.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
1.02 to 1.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.99 to 1.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.88 to 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.84 to 0.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.76 to 0.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.77 to 0.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.85 to 1.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.157
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.68 to 1.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.53 to 1.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.48 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.57 to 1.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.67 to 1.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.32 to 0.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.73 to 0.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
1.51 to 1.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.86
Confidence Interval (2-Sided) 95%
1.65 to 2.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.82 to 1.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Quintile 1 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.157
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
1.00 to 1.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Quintile 2 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
1.04 to 1.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Quintile 3 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.55 to 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Quintile 4 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.67 to 1.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (Quintile 5 - Urban area)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.56 to 1.15
Estimation Comments [Not Specified]
4.Primary Outcome
Title Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)
Hide Description Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.
Arm/Group Title Apixaban: Naive Apixaban: Non Naive Acenocoumarol: Naive Acenocoumarol: Non-Naive Warfarin: Naive Warfarin: Non-Naive Dabigatran: Naive Dabigatran: Non-Naive Rivaroxaban: Naive Rivaroxaban: Non-Naive
Hide Arm/Group Description:
Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.
Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.
Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Overall Number of Participants Analyzed 4712 1423 32212 192 2286 363 2855 953 5132 1562
Measure Type: Count of Participants
Unit of Measure: Participants
Missing
1424
  30.2%
261
  18.3%
6898
  21.4%
34
  17.7%
509
  22.3%
87
  24.0%
960
  33.6%
178
  18.7%
1746
  34.0%
311
  19.9%
18.5 - 25 kg per m^2 (Normal)
423
   9.0%
253
  17.8%
4471
  13.9%
30
  15.6%
295
  12.9%
78
  21.5%
272
   9.5%
144
  15.1%
464
   9.0%
271
  17.3%
Less than (<) 18.5 kg per m^2 (Underweight)
12
   0.3%
6
   0.4%
141
   0.4%
0
   0.0%
6
   0.3%
2
   0.6%
10
   0.4%
8
   0.8%
16
   0.3%
0
   0.0%
25 - 30 kg per m^2 (Overweight)
1229
  26.1%
493
  34.6%
10074
  31.3%
68
  35.4%
712
  31.1%
119
  32.8%
735
  25.7%
306
  32.1%
1289
  25.1%
482
  30.9%
Greater than (>) 30 kg per m^2 (Obese)
1624
  34.5%
410
  28.8%
10628
  33.0%
60
  31.3%
764
  33.4%
77
  21.2%
878
  30.8%
317
  33.3%
1617
  31.5%
498
  31.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.91 to 1.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.38
Confidence Interval (2-Sided) 95%
0.58 to 3.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.88 to 1.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Dabigatran: Naive
Comments Dabigatran vs. Apixaban in naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.76 to 0.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.66 to 1.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.99
Confidence Interval (2-Sided) 95%
0.68 to 6.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.227
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.75 to 1.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Dabigatran: Non-Naive
Comments Dabigatran vs. Apixaban in non-naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
1.03 to 1.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.88 to 1.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.58 to 2.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.87 to 1.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Rivaroxaban: Naive
Comments Rivaroxaban vs. Apixaban in naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.80 to 0.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.80 to 1.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
0.02 to 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.227
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.72 to 0.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Rivaroxaban: Non-Naive
Comments Rivaroxaban vs. Apixaban in non-naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.99 to 1.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.63
Confidence Interval (2-Sided) 95%
1.47 to 1.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
0.98 to 3.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Naive
Comments Acenocoumarol vs. Apixaban in naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
1.20 to 1.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.88 to 1.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.56 to 1.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.13 to 8.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.227
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.75 to 1.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Acenocoumarol: Non-Naive
Comments Acenocoumarol vs. Apixaban in non-naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.81 to 1.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
1.28 to 1.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (<18.5 kg per m^2 Underweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.36 to 2.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Naive
Comments Warfarin vs. Apixaban in naive participants (25 - 30 kg per m^2 Overweight)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
1.15 to 1.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Apixaban: Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in naive participants (>30 kg per m^2 Obese)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.86 to 1.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Apixaban: Non Naive, Warfarin: Non-Naive
Comments Warfarin vs. Apixaban in non-naive participants (18.5 - 25 kg per m^2 Normal)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.95 to 1.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview