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Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients

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ClinicalTrials.gov Identifier: NCT00144339
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : August 17, 2009
Last Update Posted : May 20, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: tiotropium
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
09 Jan 2003 – 22 Feb 2008; 490 centers in 37 countries

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo once daily
Tiotropium Bromide Inhalation Capsules 18 mcg once daily

Participant Flow:   Overall Study
    Placebo   Tiotropium Bromide Inhalation Capsules 18 mcg
STARTED   3006   2986 
COMPLETED   1648   1887 
NOT COMPLETED   1358   1099 
Adverse Event                746                627 
Protocol Violation                75                48 
Withdrawal by Subject                403                300 
Lost to Follow-up                76                64 
Other                58                60 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily
Total Total of all reporting groups

Baseline Measures
   Placebo   Tiotropium Bromide Inhalation Capsules 18 mcg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 3006   2986   5992 
Age 
[Units: Years]
Mean (Standard Deviation) 		 64.52  (8.48)   64.50  (8.41)   64.51  (8.45) 
Gender 
[Units: Participants]
 		     
Female   784   735   1519 
Male   2222   2251   4473 


  Outcome Measures

1.  Primary:   Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]
  Show Outcome Measure 1

2.  Primary:   Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]
  Show Outcome Measure 2

3.  Secondary:   Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. ]
  Show Outcome Measure 3

4.  Secondary:   Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
  Show Outcome Measure 4

5.  Secondary:   Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]
  Show Outcome Measure 5

6.  Secondary:   Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]
  Show Outcome Measure 6

7.  Secondary:   Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]
  Show Outcome Measure 7

8.  Secondary:   Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years   [ Time Frame: From day 30 to 4 years ]
  Show Outcome Measure 8

9.  Secondary:   Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score   [ Time Frame: From month 6 to 4 years ]
  Show Outcome Measure 9

10.  Secondary:   Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. ]
  Show Outcome Measure 10

11.  Secondary:   Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
  Show Outcome Measure 11

12.  Secondary:   Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
  Show Outcome Measure 12

13.  Secondary:   Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment   [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]
  Show Outcome Measure 13

14.  Secondary:   Time to First Exacerbation   [ Time Frame: From Day 1 to 4 years ]
  Show Outcome Measure 14

15.  Secondary:   Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year   [ Time Frame: Day 1 to 4 years ]
  Show Outcome Measure 15

16.  Secondary:   Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation   [ Time Frame: Day 1 to 4 years ]
  Show Outcome Measure 16

17.  Secondary:   Number of Exacerbation Days Per Patient Year   [ Time Frame: Day 1 to 4 years ]
  Show Outcome Measure 17

18.  Secondary:   Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)   [ Time Frame: Day 1 to 4 years ]
  Show Outcome Measure 18

19.  Secondary:   Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization   [ Time Frame: From Day 1 to 4 years ]
  Show Outcome Measure 19

20.  Secondary:   Number of Exacerbation Leading to Hospitalization   [ Time Frame: From Day 1 to 4 years ]
  Show Outcome Measure 20

21.  Secondary:   Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization   [ Time Frame: From Day 1 to 4 years ]
  Show Outcome Measure 21

22.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1   [ Time Frame: Month 1 ]
  Show Outcome Measure 22

23.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1   [ Time Frame: Month 1 ]
  Show Outcome Measure 23

24.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 24

25.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 25

26.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 26

27.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 27

28.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18   [ Time Frame: Month 18 ]
  Show Outcome Measure 28

29.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18   [ Time Frame: Month 18 ]
  Show Outcome Measure 29

30.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24   [ Time Frame: Month 24 ]
  Show Outcome Measure 30

31.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24   [ Time Frame: Month 24 ]
  Show Outcome Measure 31

32.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30   [ Time Frame: Month 30 ]
  Show Outcome Measure 32

33.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30   [ Time Frame: Month 30 ]
  Show Outcome Measure 33

34.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36   [ Time Frame: Month 36 ]
  Show Outcome Measure 34

35.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36   [ Time Frame: Month 36 ]
  Show Outcome Measure 35

36.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42   [ Time Frame: Month 42 ]
  Show Outcome Measure 36

37.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42   [ Time Frame: Month 42 ]
  Show Outcome Measure 37

38.  Secondary:   Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48   [ Time Frame: Month 48 ]
  Show Outcome Measure 38

39.  Secondary:   Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48   [ Time Frame: Month 48 ]
  Show Outcome Measure 39

40.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1   [ Time Frame: Month 1 ]
  Show Outcome Measure 40

41.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1   [ Time Frame: Month 1 ]
  Show Outcome Measure 41

42.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 42

43.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 43

44.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 44

45.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 45

46.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18   [ Time Frame: Month 18 ]
  Show Outcome Measure 46

47.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18   [ Time Frame: Month 18 ]
  Show Outcome Measure 47

48.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24   [ Time Frame: Month 24 ]
  Show Outcome Measure 48

49.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24   [ Time Frame: Month 24 ]
  Show Outcome Measure 49

50.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30   [ Time Frame: Month 30 ]
  Show Outcome Measure 50

51.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30   [ Time Frame: Month 30 ]
  Show Outcome Measure 51

52.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36   [ Time Frame: Month 36 ]
  Show Outcome Measure 52

53.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36   [ Time Frame: Month 36 ]
  Show Outcome Measure 53

54.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42   [ Time Frame: Month 42 ]
  Show Outcome Measure 54

55.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42   [ Time Frame: Month 42 ]
  Show Outcome Measure 55

56.  Secondary:   Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48   [ Time Frame: Month 48 ]
  Show Outcome Measure 56

57.  Secondary:   Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48   [ Time Frame: Month 48 ]
  Show Outcome Measure 57

58.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1   [ Time Frame: Month 1 ]
  Show Outcome Measure 58

59.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1   [ Time Frame: Month 1 ]
  Show Outcome Measure 59

60.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 60

61.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 61

62.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 62

63.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 63

64.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18   [ Time Frame: Month 18 ]
  Show Outcome Measure 64

65.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18   [ Time Frame: Month 18 ]
  Show Outcome Measure 65

66.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24   [ Time Frame: Month 24 ]
  Show Outcome Measure 66

67.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24   [ Time Frame: Month 24 ]
  Show Outcome Measure 67

68.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30   [ Time Frame: Month 30 ]
  Show Outcome Measure 68

69.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30   [ Time Frame: Month 30 ]
  Show Outcome Measure 69

70.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36   [ Time Frame: Month 36 ]
  Show Outcome Measure 70

71.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36   [ Time Frame: Month 36 ]
  Show Outcome Measure 71

72.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42   [ Time Frame: Month 42 ]
  Show Outcome Measure 72

73.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42   [ Time Frame: Month 42 ]
  Show Outcome Measure 73

74.  Secondary:   Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48   [ Time Frame: Month 48 ]
  Show Outcome Measure 74

75.  Secondary:   Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48   [ Time Frame: Month 48 ]
  Show Outcome Measure 75

76.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 76

77.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 77

78.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18   [ Time Frame: Month 18 ]
  Show Outcome Measure 78

79.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24   [ Time Frame: Month 24 ]
  Show Outcome Measure 79

80.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30   [ Time Frame: Month 30 ]
  Show Outcome Measure 80

81.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36   [ Time Frame: Month 36 ]
  Show Outcome Measure 81

82.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42   [ Time Frame: Month 42 ]
  Show Outcome Measure 82

83.  Secondary:   Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48   [ Time Frame: Month 48 ]
  Show Outcome Measure 83

84.  Secondary:   Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days ]
  Show Outcome Measure 84

85.  Secondary:   Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)   [ Time Frame: Day 1 to day 1470 ]
  Show Outcome Measure 85

86.  Secondary:   Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days ]
  Show Outcome Measure 86

87.  Secondary:   Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)   [ Time Frame: Day 1 to day 1470 ]
  Hide Outcome Measure 87

Measure Type Secondary
Measure Title Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)
Measure Description The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used
Time Frame Day 1 to day 1470  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Once daily
Tiotropium Bromide Inhalation Capsules 18 mcg Once daily

Measured Values
   Placebo   Tiotropium Bromide Inhalation Capsules 18 mcg 
Participants Analyzed   3006   2986 
Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days) 
[Units: Participants]
 		   
Number of patients with lower respiratory death   173   153 
Percentage patients with lower respiratory death   5.8   5.1 


Statistical Analysis 1 for Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.2377
Hazard Ratio (HR) [5] 0.88
95% Confidence Interval 0.71 to 1.09
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tiotropium bromide vs. placebo



88.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (System Organ Class = Cardiac Disorders)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Show Outcome Measure 88

89.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Angina)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Show Outcome Measure 89

90.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Atrial Fibrillation)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Show Outcome Measure 90

91.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Show Outcome Measure 91

92.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure Congestive)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Show Outcome Measure 92

93.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Coronary Artery Disease)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Show Outcome Measure 93

94.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Myocardial Infarction)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Show Outcome Measure 94

95.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (System Organ Class = Lower Respiratory System Disorders)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Show Outcome Measure 95

96.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Bronchitis)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Show Outcome Measure 96

97.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Chronic Obstructive Pulmonary Disease (COPD) Exacerbation)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Show Outcome Measure 97

98.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Dyspnoea)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Show Outcome Measure 98

99.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Pneumonia)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Show Outcome Measure 99

100.  Other Pre-specified:   Incidence Rate of Serious Adverse Event (Preferred Term = Respiratory Failure)   [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days ]
  Show Outcome Measure 100

101.  Post-Hoc:   Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1440 Days)   [ Time Frame: Day 1 to day 1440 ]
  Show Outcome Measure 101


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Tio patients had significantly longer drug exposure,thus had increased chance of AE.Simple frequencies are biased for AE comparisons;exposure-adjusted incidence rates (IR) should be used. IR for serious AE(>1% patients) are in Outcome Measures.


  More Information