ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness and Safety of Ramipril Alone Compared With Telmisartan Alone and in Combination With Ramipril in Patients at High Risk for Cardiovascular Events. Patients Intolerant to Ramipril Were Entered in TRANSCEND, Telmisartan Compared to Placebo.

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: NCT00153101
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : August 25, 2009
Last Update Posted : May 20, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Primary Purpose: Prevention
Condition Cardiovascular Diseases
Interventions Drug: Telmisartan
Drug: Combination of Telmisartan and Ramipril
Drug: Ramipril
Enrollment 31546
Recruitment Details At the randomization visit, patients who have adhered to the medication regimen (consumed > 75% of ramipril + telmisartan during run-in phase) and were Angiotensin Converting Enzyme (ACE) tolerant were randomized into the main study (ONTARGET). ACE intolerant patients were randomized into the parallel trial (TRANSCEND).
Pre-assignment Details  
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET) Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. Telmisartan 80mg tablet, one tablet administered once daily in the morning. Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Period Title: Overall Study
Started 8502 8542 8576 2954 2972
Completed 8485 8524 8561 2946 2962
Not Completed 17 18 15 8 10
Reason Not Completed
Lost to Follow-up             14             14             12             5             5
Withdrawal by Subject             3             4             3             3             5
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET) Telmisartan (TRANSCEND) Placebo (TRANSCEND) Total
Hide Arm/Group Description Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. Telmisartan 80mg tablet, one tablet administered once daily in the morning. Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. Total of all reporting groups
Overall Number of Baseline Participants 8502 8542 8576 2954 2972 31546
Hide Baseline Analysis Population Description
The Full Analysis Set (FAS) followed the intent-to-treat principle; it included all patients who were randomised and had any follow-up information available (i.e. 'date last seen' was available for these patients).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8502 participants 8542 participants 8576 participants 2954 participants 2972 participants 31546 participants
66.4  (7.3) 66.4  (7.1) 66.4  (7.2) 66.9  (7.3) 66.9  (7.4) 66.5  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8502 participants 8542 participants 8576 participants 2954 participants 2972 participants 31546 participants
Female
2250
  26.5%
2250
  26.3%
2331
  27.2%
1280
  43.3%
1267
  42.6%
9378
  29.7%
Male
6252
  73.5%
6292
  73.7%
6245
  72.8%
1674
  56.7%
1705
  57.4%
22168
  70.3%
1.Primary Outcome
Title ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
Hide Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 8502 8542 8576
Measure Type: Number
Unit of Measure: participants
1386 1423 1412
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8462
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval 95%
0.92 to 1.07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin was 1.13
Statistical Test of Hypothesis P-Value 0.0019
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval 97.5%
0.93 to 1.10
Estimation Comments [Not Specified]
2.Primary Outcome
Title ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients
Hide Description

ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.

These renal outcomes were not adjudicated (apart from death).

Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the Full Analysis Set (FAS [DN]) consisting of all randomised patients with diabetic nephropathy (UACR ≥300 mg/g Crea) of the ONTARGET trial.
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 248 288 238
Measure Type: Number
Unit of Measure: participants
108 119 112
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5461
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.71 to 1.20
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3436
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval 95%
0.68 to 1.14
Estimation Comments [Not Specified]
3.Primary Outcome
Title TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
Hide Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2954 2972
Measure Type: Number
Unit of Measure: participants
465 504
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2192
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval 95%
0.81 to 1.05
Estimation Comments [Not Specified]
4.Secondary Outcome
Title ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Hide Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, non-fatal myocardial infarction or non-fatal stroke
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 8502 8542 8576
Measure Type: Number
Unit of Measure: participants
1200 1190 1210
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9086
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.00
Confidence Interval 95%
0.93 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin was 1.13
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval 97.5%
0.90 to 1.08
Estimation Comments [Not Specified]
5.Secondary Outcome
Title ONTARGET. Cardiovascular Death
Hide Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint cardiovascular death.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 8502 8542 8576
Measure Type: Number
Unit of Measure: participants
620 598 603
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4535
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval 95%
0.93 to 1.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9421
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.00
Confidence Interval 95%
0.89 to 1.12
Estimation Comments [Not Specified]
6.Secondary Outcome
Title ONTARGET. Non-fatal Myocardial Infarction
Hide Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint non-fatal myocardial infarction.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 8502 8542 8576
Measure Type: Number
Unit of Measure: participants
424 431 400
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2909
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval 95%
0.94 to 1.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2534
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval 95%
0.94 to 1.24
Estimation Comments [Not Specified]
7.Secondary Outcome
Title ONTARGET. Non-fatal Stroke
Hide Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint non-fatal stroke.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 8502 8542 8576
Measure Type: Number
Unit of Measure: participants
364 364 402
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2248
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval 95%
0.79 to 1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1829
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval 95%
0.79 to 1.05
Estimation Comments [Not Specified]
8.Secondary Outcome
Title ONTARGET. Hospitalization for Congestive Heart Failure
Hide Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint hospitalization for congestive heart failure.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 8502 8542 8576
Measure Type: Number
Unit of Measure: participants
332 394 354
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4984
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval 95%
0.82 to 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1203
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.12
Confidence Interval 95%
0.97 to 1.29
Estimation Comments [Not Specified]
9.Secondary Outcome
Title ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients
Hide Description Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS [DN] of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 248 288 238
Measure Type: Number
Unit of Measure: participants
30 24 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4221
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.73 to 2.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7305
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval 95%
0.51 to 1.60
Estimation Comments [Not Specified]
10.Secondary Outcome
Title ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients
Hide Description ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS [DN] of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 248 288 238
Measure Type: Number
Unit of Measure: participants
30 24 32
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6248
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval 95%
0.54 to 1.45
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0751
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.36 to 1.05
Estimation Comments [Not Specified]
11.Secondary Outcome
Title ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients
Hide Description Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS [DN] of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 248 288 238
Measure Type: Number
Unit of Measure: participants
75 92 83
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3682
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval 95%
0.63 to 1.18
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6014
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval 95%
0.69 to 1.24
Estimation Comments [Not Specified]
12.Secondary Outcome
Title ONTARGET. Doubling of Serum Creatinine
Hide Description ONTARGET. Nephropathy subcategory: doubling of serum creatinine
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 8483 8525 8557
Measure Type: Number
Unit of Measure: participants
167 160 149
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2550
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.14
Confidence Interval 95%
0.91 to 1.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5297
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.07
Confidence Interval 95%
0.86 to 1.34
Estimation Comments [Not Specified]
13.Secondary Outcome
Title ONTARGET. Progression to ESRD
Hide Description ONTARGET. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m².
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 8502 8542 8576
Measure Type: Number
Unit of Measure: participants
79 67 71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4593
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.13
Confidence Interval 95%
0.82 to 1.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7468
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval 95%
0.68 to 1.32
Estimation Comments [Not Specified]
14.Secondary Outcome
Title ONTARGET. New Microalbuminuria
Hide Description ONTARGET. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥30 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <30 mg/g Crea at baseline.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 6446 6456 6532
Measure Type: Number
Unit of Measure: participants
763 799 869
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0133
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval 95%
0.80 to 0.97
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1251
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval 95%
0.84 to 1.02
Estimation Comments [Not Specified]
15.Secondary Outcome
Title ONTARGET. New Macroalbuminuria
Hide Description ONTARGET. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥300 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <300 mg/g Crea at baseline.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 7486 7465 7552
Measure Type: Number
Unit of Measure: participants
205 229 257
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0213
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.81
Confidence Interval 95%
0.67 to 0.97
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2396
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval 95%
0.75 to 1.07
Estimation Comments [Not Specified]
16.Secondary Outcome
Title ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria
Hide Description ONTARGET. Nephropathy subcategory: Combined endpoint of doubling of serum creatinine, progression to ESRD, new microalbuminuria, or new macroalbuminuria
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 8502 8542 8576
Measure Type: Number
Unit of Measure: participants
1067 1101 1190
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0111
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval 95%
0.83 to 0.98
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0606
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval 95%
0.85 to 1.00
Estimation Comments [Not Specified]
17.Secondary Outcome
Title ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria
Hide Description ONTARGET. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 1337 1361 1314
Measure Type: Number
Unit of Measure: participants
508 483 448
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0082
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.19
Confidence Interval 95%
1.05 to 1.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2164
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval 95%
0.95 to 1.23
Estimation Comments [Not Specified]
18.Secondary Outcome
Title ONTARGET. Newly Diagnosed Congestive Heart Failure
Hide Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Congestive Heart failure.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 8502 8542 8576
Measure Type: Number
Unit of Measure: participants
469 529 503
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3732
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval 95%
0.83 to 1.07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3633
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval 95%
0.94 to 1.20
Estimation Comments [Not Specified]
19.Secondary Outcome
Title ONTARGET. Cardiovascular Revascularization Procedure
Hide Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET).
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the ONTARGET trial
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 8502 8542 8576
Measure Type: Number
Unit of Measure: participants
1303 1290 1269
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2713
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval 95%
0.97 to 1.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5150
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval 95%
0.95 to 1.11
Estimation Comments [Not Specified]
20.Secondary Outcome
Title ONTARGET. Newly Diagnosed Diabetes
Hide Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without baseline diabetes.
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 5037 4992 5123
Measure Type: Number
Unit of Measure: participants
224 277 249
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments for subjects without diabetes at baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3485
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval 95%
0.77 to 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments for subjects without diabetes at baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1235
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.14
Confidence Interval 95%
0.96 to 1.36
Estimation Comments [Not Specified]
21.Secondary Outcome
Title ONTARGET. Cognitive Decline
Hide Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 7461 7566 7602
Measure Type: Number
Unit of Measure: participants
561 600 577
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments for subjects with available Mini Mental State Examination (MMSE) at baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8690
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.99
Confidence Interval 95%
0.89 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments for subjects with available Mini Mental State Examination (MMSE) at baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4337
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.04
Confidence Interval 95%
0.94 to 1.17
Estimation Comments [Not Specified]
22.Secondary Outcome
Title ONTARGET. New Onset of Atrial Fibrillation
Hide Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of endpoint new onset of atrial fibrillation.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without atrial fibrillation at baseline.
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Hide Arm/Group Description:
Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Overall Number of Participants Analyzed 8218 8259 8296
Measure Type: Number
Unit of Measure: participants
542 560 586
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan/Ramipril (ONTARGET), Ramipril (ONTARGET)
Comments for subjects without atrial fibrillation at baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2666
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval 95%
0.83 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan (ONTARGET), Ramipril (ONTARGET)
Comments for subjects without atrial fibrillation at baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4784
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval 95%
0.85 to 1.08
Estimation Comments [Not Specified]
23.Secondary Outcome
Title TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Hide Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2954 2972
Measure Type: Number
Unit of Measure: participants
384 440
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0483
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval 95%
0.76 to 1.00
Estimation Comments [Not Specified]
24.Secondary Outcome
Title TRANSCEND. Cardiovascular Death
Hide Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint cardiovascular death.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2954 2972
Measure Type: Number
Unit of Measure: participants
227 223
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7764
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval 95%
0.85 to 1.24
Estimation Comments [Not Specified]
25.Secondary Outcome
Title TRANSCEND. Non-fatal Myocardial Infarction
Hide Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint non-fatal myocardial infarction.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2954 2972
Measure Type: Number
Unit of Measure: participants
114 145
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0574
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.79
Confidence Interval 95%
0.62 to 1.01
Estimation Comments [Not Specified]
26.Secondary Outcome
Title TRANSCEND. Non-fatal Stroke
Hide Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2954 2972
Measure Type: Number
Unit of Measure: participants
112 136
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1365
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.83
Confidence Interval 95%
0.64 to 1.06
Estimation Comments [Not Specified]
27.Secondary Outcome
Title TRANSCEND. Hospitalization for Congestive Heart Failure
Hide Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2954 2972
Measure Type: Number
Unit of Measure: participants
134 129
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6940
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Confidence Interval 95%
0.82 to 1.34
Estimation Comments [Not Specified]
28.Secondary Outcome
Title TRANSCEND. Doubling of Serum Creatinine
Hide Description TRANSCEND. Nephropathy subcategory: doubling of serum creatinine
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2950 2965
Measure Type: Number
Unit of Measure: participants
62 40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0245
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.58
Confidence Interval 95%
1.06 to 2.35
Estimation Comments [Not Specified]
29.Secondary Outcome
Title TRANSCEND. Progression to ESRD
Hide Description TRANSCEND. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73m²
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2954 2972
Measure Type: Number
Unit of Measure: participants
11 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5798
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval 95%
0.36 to 1.76
Estimation Comments [Not Specified]
30.Secondary Outcome
Title TRANSCEND. New Microalbuminuria
Hide Description TRANSCEND. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as UACR ≥30 mg/g creatinine [Crea] in patients with a UACR <30 mg/g Crea at baseline
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2372 2403
Measure Type: Number
Unit of Measure: participants
276 363
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.76
Confidence Interval 95%
0.65 to 0.89
Estimation Comments [Not Specified]
31.Secondary Outcome
Title TRANSCEND. New Macroalbuminuria
Hide Description TRANSCEND. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as UACR ≥300 mg/g creatinine [Crea] in patients with a UACR <300 mg/g Crea at baseline
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2658 2676
Measure Type: Number
Unit of Measure: participants
66 101
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0085
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.66
Confidence Interval 95%
0.48 to 0.90
Estimation Comments [Not Specified]
32.Secondary Outcome
Title TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria
Hide Description TRANSCEND. Nephropathy subcategory: Combined endpoint of doubling serum creatinine, progression to ESRD, new microalbuminuria or new macroalbuminuria
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2954 2972
Measure Type: Number
Unit of Measure: participants
357 448
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0015
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval 95%
0.69 to 0.92
Estimation Comments [Not Specified]
33.Secondary Outcome
Title TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria
Hide Description TRANSCEND. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 319 318
Measure Type: Number
Unit of Measure: participants
135 110
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0101
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.39
Confidence Interval 95%
1.08 to 1.79
Estimation Comments [Not Specified]
34.Secondary Outcome
Title TRANSCEND. New Onset of Atrial Fibrillation
Hide Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2851 2870
Measure Type: Number
Unit of Measure: participants
181 182
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9563
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval 95%
0.82 to 1.24
Estimation Comments [Not Specified]
35.Secondary Outcome
Title TRANSCEND. Cognitive Decline
Hide Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients of the TRANSCEND trial treated with Telmisartan 80mg or telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2642 2589
Measure Type: Number
Unit of Measure: participants
230 192
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0868
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.17
Confidence Interval 95%
0.98 to 1.41
Estimation Comments [Not Specified]
36.Secondary Outcome
Title TRANSCEND. Newly Diagnosed Diabetes
Hide Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only for patients of TRANSCEND trial treated with Telmisartan 80mg or Telmisartan 80mg placebo daily for 56 months without diabetes at baseline.
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 1710 1751
Measure Type: Number
Unit of Measure: participants
124 165
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0172
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.75
Confidence Interval 95%
0.60 to 0.95
Estimation Comments [Not Specified]
37.Secondary Outcome
Title TRANSCEND. Cardiovascular Revascularization Procedure
Hide Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2954 2972
Measure Type: Number
Unit of Measure: participants
351 390
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1431
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval 95%
0.78 to 1.04
Estimation Comments [Not Specified]
38.Secondary Outcome
Title TRANSCEND. Newly Diagnosed Congestive Heart Failure
Hide Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time Frame 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS of the TRANSCEND trial
Arm/Group Title Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description:
Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Overall Number of Participants Analyzed 2949 2965
Measure Type: Number
Unit of Measure: participants
187 191
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan (TRANSCEND), Placebo (TRANSCEND)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8974
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval 95%
0.81 to 1.21
Estimation Comments [Not Specified]
Time Frame Up to 6 Years
Adverse Event Reporting Description In the ONTARGET part, the time frame is up to 5.5 years and in the TRANSCEND part up to 6 years
 
Arm/Group Title Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET) Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Hide Arm/Group Description Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. Telmisartan 80mg tablet, one tablet administered once daily in the morning. Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
All-Cause Mortality
Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET) Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET) Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5268/8502 (61.96%)   5506/8542 (64.46%)   5375/8576 (62.67%)   1781/2954 (60.29%)   1830/2972 (61.57%) 
Blood and lymphatic system disorders           
Agranulocytosis  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Anaemia  1  125/8502 (1.47%)  156/8542 (1.83%)  131/8576 (1.53%)  43/2954 (1.46%)  36/2972 (1.21%) 
Anaemia haemolytic autoimmune  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Anaemia macrocytic  1  2/8502 (0.02%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Anaemia of chronic disease  1  3/8502 (0.04%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Anaemia vitamin B12 deficiency  1  2/8502 (0.02%)  0/8542 (0.00%)  0/8576 (0.00%)  1/2954 (0.03%)  0/2972 (0.00%) 
Aplastic anaemia  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  1/2972 (0.03%) 
Autoimmune thrombocytopenia  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  1/2954 (0.03%)  0/2972 (0.00%) 
Coagulopathy  1  1/8502 (0.01%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  1/2972 (0.03%) 
Disseminated intravascular coagulation  1  1/8502 (0.01%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Febrile bone marrow aplasia  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  1/2954 (0.03%)  0/2972 (0.00%) 
Febrile neutropenia  1  4/8502 (0.05%)  1/8542 (0.01%)  2/8576 (0.02%)  1/2954 (0.03%)  0/2972 (0.00%) 
Haemolysis  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Haemolytic anaemia  1  0/8502 (0.00%)  0/8542 (0.00%)  2/8576 (0.02%)  0/2954 (0.00%)  1/2972 (0.03%) 
Haemorrhagic anaemia  1  1/8502 (0.01%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Haemorrhagic diathesis  1  3/8502 (0.04%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Haemorrhagic disorder  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Hyperglobulinaemia  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Hypersplenism  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  1/2954 (0.03%)  0/2972 (0.00%) 
Hypochromic anaemia  1  2/8502 (0.02%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Idiopathic thrombocytopenic purpura  1  1/8502 (0.01%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Iron deficiency anaemia  1  2/8502 (0.02%)  6/8542 (0.07%)  8/8576 (0.09%)  2/2954 (0.07%)  2/2972 (0.07%) 
Leukocytosis  1  2/8502 (0.02%)  1/8542 (0.01%)  4/8576 (0.05%)  1/2954 (0.03%)  0/2972 (0.00%) 
Leukopenia  1  3/8502 (0.04%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Lymphadenopathy  1  3/8502 (0.04%)  1/8542 (0.01%)  0/8576 (0.00%)  1/2954 (0.03%)  0/2972 (0.00%) 
Lymphadenopathy mediastinal  1  2/8502 (0.02%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Microcytic anaemia  1  2/8502 (0.02%)  3/8542 (0.04%)  1/8576 (0.01%)  0/2954 (0.00%)  1/2972 (0.03%) 
Nephrogenic anaemia  1  0/8502 (0.00%)  2/8542 (0.02%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Neutropenia  1  3/8502 (0.04%)  0/8542 (0.00%)  3/8576 (0.03%)  0/2954 (0.00%)  1/2972 (0.03%) 
Normochromic normocytic anaemia  1  4/8502 (0.05%)  3/8542 (0.04%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Pancytopenia  1  8/8502 (0.09%)  1/8542 (0.01%)  2/8576 (0.02%)  1/2954 (0.03%)  1/2972 (0.03%) 
Pernicious anaemia  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Polycythaemia  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Red blood cell abnormality  1  1/8502 (0.01%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Spleen disorder  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Splenic vein thrombosis  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  1/2954 (0.03%)  0/2972 (0.00%) 
Thrombocytopenia  1  7/8502 (0.08%)  4/8542 (0.05%)  3/8576 (0.03%)  3/2954 (0.10%)  1/2972 (0.03%) 
Thrombocytopenic purpura  1  0/8502 (0.00%)  0/8542 (0.00%)  3/8576 (0.03%)  0/2954 (0.00%)  1/2972 (0.03%) 
Cardiac disorders           
AV dissociation  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Acute coronary syndrome  1  6/8502 (0.07%)  11/8542 (0.13%)  7/8576 (0.08%)  1/2954 (0.03%)  3/2972 (0.10%) 
Acute left ventricular failure  1  0/8502 (0.00%)  4/8542 (0.05%)  0/8576 (0.00%)  0/2954 (0.00%)  1/2972 (0.03%) 
Acute myocardial infarction  1  2/8502 (0.02%)  1/8542 (0.01%)  1/8576 (0.01%)  0/2954 (0.00%)  1/2972 (0.03%) 
Adams-Stokes syndrome  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Angina pectoris  1  1206/8502 (14.18%)  1296/8542 (15.17%)  1244/8576 (14.51%)  418/2954 (14.15%)  455/2972 (15.31%) 
Angina unstable  1  7/8502 (0.08%)  15/8542 (0.18%)  12/8576 (0.14%)  0/2954 (0.00%)  5/2972 (0.17%) 
Aortic valve disease  1  0/8502 (0.00%)  0/8542 (0.00%)  2/8576 (0.02%)  0/2954 (0.00%)  0/2972 (0.00%) 
Aortic valve incompetence  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  1/2972 (0.03%) 
Aortic valve stenosis  1  0/8502 (0.00%)  2/8542 (0.02%)  5/8576 (0.06%)  1/2954 (0.03%)  0/2972 (0.00%) 
Arrhythmia  1  1/8502 (0.01%)  3/8542 (0.04%)  7/8576 (0.08%)  0/2954 (0.00%)  0/2972 (0.00%) 
Arrhythmia supraventricular  1  38/8502 (0.45%)  41/8542 (0.48%)  41/8576 (0.48%)  19/2954 (0.64%)  15/2972 (0.50%) 
Arteriosclerosis coronary artery  1  2/8502 (0.02%)  2/8542 (0.02%)  2/8576 (0.02%)  1/2954 (0.03%)  0/2972 (0.00%) 
Arteriospasm coronary  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Atrial fibrillation  1  449/8502 (5.28%)  499/8542 (5.84%)  509/8576 (5.94%)  146/2954 (4.94%)  149/2972 (5.01%) 
Atrial flutter  1  2/8502 (0.02%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Atrial thrombosis  1  1/8502 (0.01%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Atrioventricular block  1  6/8502 (0.07%)  4/8542 (0.05%)  7/8576 (0.08%)  3/2954 (0.10%)  2/2972 (0.07%) 
Atrioventricular block complete  1  18/8502 (0.21%)  18/8542 (0.21%)  11/8576 (0.13%)  3/2954 (0.10%)  2/2972 (0.07%) 
Atrioventricular block first degree  1  3/8502 (0.04%)  0/8542 (0.00%)  2/8576 (0.02%)  1/2954 (0.03%)  0/2972 (0.00%) 
Atrioventricular block second degree  1  4/8502 (0.05%)  6/8542 (0.07%)  4/8576 (0.05%)  1/2954 (0.03%)  2/2972 (0.07%) 
Bifascicular block  1  0/8502 (0.00%)  1/8542 (0.01%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Bradyarrhythmia  1  5/8502 (0.06%)  2/8542 (0.02%)  2/8576 (0.02%)  2/2954 (0.07%)  1/2972 (0.03%) 
Bradycardia  1  30/8502 (0.35%)  30/8542 (0.35%)  32/8576 (0.37%)  8/2954 (0.27%)  10/2972 (0.34%) 
Bundle branch block bilateral  1  1/8502 (0.01%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Bundle branch block left  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  1/2954 (0.03%)  0/2972 (0.00%) 
Bundle branch block right  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Cardiac aneurysm  1  2/8502 (0.02%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Cardiac arrest  1  35/8502 (0.41%)  37/8542 (0.43%)  37/8576 (0.43%)  12/2954 (0.41%)  9/2972 (0.30%) 
Cardiac disorder  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Cardiac failure  1  11/8502 (0.13%)  6/8542 (0.07%)  7/8576 (0.08%)  2/2954 (0.07%)  5/2972 (0.17%) 
Cardiac failure acute  1  47/8502 (0.55%)  27/8542 (0.32%)  52/8576 (0.61%)  26/2954 (0.88%)  15/2972 (0.50%) 
Cardiac failure chronic  1  0/8502 (0.00%)  2/8542 (0.02%)  1/8576 (0.01%)  1/2954 (0.03%)  0/2972 (0.00%) 
Cardiac failure congestive  1  400/8502 (4.70%)  484/8542 (5.67%)  465/8576 (5.42%)  174/2954 (5.89%)  172/2972 (5.79%) 
Cardiac pseudoaneurysm  1  0/8502 (0.00%)  2/8542 (0.02%)  0/8576 (0.00%)  0/2954 (0.00%)  1/2972 (0.03%) 
Cardiac tamponade  1  0/8502 (0.00%)  4/8542 (0.05%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Cardiac valve disease  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  1/2972 (0.03%) 
Cardiac valve sclerosis  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  1/2972 (0.03%) 
Cardio-respiratory arrest  1  8/8502 (0.09%)  7/8542 (0.08%)  2/8576 (0.02%)  1/2954 (0.03%)  3/2972 (0.10%) 
Cardiogenic shock  1  7/8502 (0.08%)  6/8542 (0.07%)  9/8576 (0.10%)  2/2954 (0.07%)  0/2972 (0.00%) 
Cardiomegaly  1  0/8502 (0.00%)  1/8542 (0.01%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Cardiomyopathy  1  1/8502 (0.01%)  1/8542 (0.01%)  1/8576 (0.01%)  1/2954 (0.03%)  0/2972 (0.00%) 
Cardiopulmonary failure  1  1/8502 (0.01%)  2/8542 (0.02%)  2/8576 (0.02%)  0/2954 (0.00%)  0/2972 (0.00%) 
Cardiovascular disorder  1  2/8502 (0.02%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Congestive cardiomyopathy  1  1/8502 (0.01%)  1/8542 (0.01%)  1/8576 (0.01%)  0/2954 (0.00%)  1/2972 (0.03%) 
Cor pulmonale  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Coronary artery dilatation  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Coronary artery disease  1  12/8502 (0.14%)  15/8542 (0.18%)  9/8576 (0.10%)  5/2954 (0.17%)  2/2972 (0.07%) 
Coronary artery occlusion  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Diabetic cardiomyopathy  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Electromechanical dissociation  1  0/8502 (0.00%)  1/8542 (0.01%)  1/8576 (0.01%)  0/2954 (0.00%)  1/2972 (0.03%) 
Extrasystoles  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Heart valve incompetence  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  1/2954 (0.03%)  0/2972 (0.00%) 
Hypertensive heart disease  1  0/8502 (0.00%)  3/8542 (0.04%)  2/8576 (0.02%)  1/2954 (0.03%)  0/2972 (0.00%) 
Intracardiac thrombus  1  0/8502 (0.00%)  1/8542 (0.01%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Ischaemic cardiomyopathy  1  2/8502 (0.02%)  0/8542 (0.00%)  2/8576 (0.02%)  0/2954 (0.00%)  0/2972 (0.00%) 
Left ventricular dysfunction  1  2/8502 (0.02%)  4/8542 (0.05%)  1/8576 (0.01%)  0/2954 (0.00%)  2/2972 (0.07%) 
Left ventricular failure  1  0/8502 (0.00%)  1/8542 (0.01%)  3/8576 (0.03%)  0/2954 (0.00%)  3/2972 (0.10%) 
Low cardiac output syndrome  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  1/2954 (0.03%)  0/2972 (0.00%) 
Mitral valve incompetence  1  3/8502 (0.04%)  1/8542 (0.01%)  2/8576 (0.02%)  0/2954 (0.00%)  2/2972 (0.07%) 
Myocardial infarction  1  456/8502 (5.36%)  480/8542 (5.62%)  457/8576 (5.33%)  138/2954 (4.67%)  161/2972 (5.42%) 
Myocardial ischaemia  1  11/8502 (0.13%)  9/8542 (0.11%)  11/8576 (0.13%)  4/2954 (0.14%)  4/2972 (0.13%) 
Myocarditis  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Nodal arrhythmia  1  0/8502 (0.00%)  3/8542 (0.04%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Nodal rhythm  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Pacemaker generated arrhythmia  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Palpitations  1  7/8502 (0.08%)  13/8542 (0.15%)  5/8576 (0.06%)  2/2954 (0.07%)  1/2972 (0.03%) 
Pericardial effusion  1  1/8502 (0.01%)  2/8542 (0.02%)  3/8576 (0.03%)  1/2954 (0.03%)  1/2972 (0.03%) 
Pericardial haemorrhage  1  0/8502 (0.00%)  1/8542 (0.01%)  2/8576 (0.02%)  0/2954 (0.00%)  0/2972 (0.00%) 
Pericarditis  1  0/8502 (0.00%)  4/8542 (0.05%)  4/8576 (0.05%)  3/2954 (0.10%)  1/2972 (0.03%) 
Prinzmetal angina  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  1/2972 (0.03%) 
Right ventricular failure  1  1/8502 (0.01%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Sick sinus syndrome  1  11/8502 (0.13%)  9/8542 (0.11%)  12/8576 (0.14%)  4/2954 (0.14%)  1/2972 (0.03%) 
Sinus arrest  1  1/8502 (0.01%)  2/8542 (0.02%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Sinus arrhythmia  1  0/8502 (0.00%)  1/8542 (0.01%)  2/8576 (0.02%)  0/2954 (0.00%)  1/2972 (0.03%) 
Sinus bradycardia  1  6/8502 (0.07%)  6/8542 (0.07%)  5/8576 (0.06%)  5/2954 (0.17%)  0/2972 (0.00%) 
Sinus tachycardia  1  0/8502 (0.00%)  1/8542 (0.01%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Supraventricular extrasystoles  1  1/8502 (0.01%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Supraventricular tachycardia  1  1/8502 (0.01%)  2/8542 (0.02%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Tachyarrhythmia  1  0/8502 (0.00%)  1/8542 (0.01%)  2/8576 (0.02%)  0/2954 (0.00%)  1/2972 (0.03%) 
Tachycardia  1  6/8502 (0.07%)  1/8542 (0.01%)  3/8576 (0.03%)  0/2954 (0.00%)  0/2972 (0.00%) 
Trifascicular block  1  1/8502 (0.01%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Ventricular arrhythmia  1  62/8502 (0.73%)  75/8542 (0.88%)  64/8576 (0.75%)  18/2954 (0.61%)  24/2972 (0.81%) 
Ventricular dysfunction  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Ventricular extrasystoles  1  1/8502 (0.01%)  1/8542 (0.01%)  1/8576 (0.01%)  1/2954 (0.03%)  0/2972 (0.00%) 
Ventricular fibrillation  1  3/8502 (0.04%)  1/8542 (0.01%)  0/8576 (0.00%)  1/2954 (0.03%)  0/2972 (0.00%) 
Ventricular remodeling  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Ventricular tachyarrhythmia  1  19/8502 (0.22%)  19/8542 (0.22%)  15/8576 (0.17%)  6/2954 (0.20%)  1/2972 (0.03%) 
Ventricular tachycardia  1  7/8502 (0.08%)  5/8542 (0.06%)  2/8576 (0.02%)  0/2954 (0.00%)  1/2972 (0.03%) 
Wandering pacemaker  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Wolff-Parkinson-White syndrome  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Congenital, familial and genetic disorders           
Alagille syndrome  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  1/2954 (0.03%)  0/2972 (0.00%) 
Arteriovenous malformation  1  1/8502 (0.01%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Atrial septal defect  1  2/8502 (0.02%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Congenital cystic kidney disease  1  3/8502 (0.04%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Dolichocolon  1  1/8502 (0.01%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Fragile X syndrome  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Gastrointestinal angiodysplasia  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Gastrointestinal angiodysplasia haemorrhagic  1  0/8502 (0.00%)  0/8542 (0.00%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Gastrointestinal malformation  1  1/8502 (0.01%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Hydrocele  1  3/8502 (0.04%)  5/8542 (0.06%)  1/8576 (0.01%)  0/2954 (0.00%)  0/2972 (0.00%) 
Kidney malformation  1  1/8502 (0.01%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Limb reduction defect  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  1/2972 (0.03%) 
Meningomyelocele  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  1/2972 (0.03%) 
Neural tube defect  1  0/8502 (0.00%)  0/8542 (0.00%)  0/8576 (0.00%)  0/2954 (0.00%)  1/2972 (0.03%) 
Oculopharyngeal dystrophy  1  0/8502 (0.00%)  1/8542 (0.01%)  0/8576 (0.00%)  0/2954 (0.00%)  0/2972 (0.00%) 
Osteogenesis imperfecta  1