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Actual Use Study of Tamsulosin in Men

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: NCT02573311
Recruitment Status : Completed
First Posted : October 9, 2015
Results First Posted : April 8, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urological Manifestations
Intervention Drug: tamsulosin hydrochloride
Enrollment 1117
Recruitment Details  
Pre-assignment Details The trial consisted of 2 parts. One was the product review phase (Part 1) and another was the actual use phase (Part 2). The number of enrolled patients in the protocol represent the number of participants (1117) who intended to purchase study product and enter part 2 of the study. All endpoints are based on part 2 of the study.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks). Cohort 2 included all men who were currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
Period Title: Disposition for Part 1
Started 1737 [1] 364 [1]
Completed 1730 [2] 361 [2]
Not Completed 7 3
Reason Not Completed
Withdrawal by Subject             7             3
[1]
Started are subjects who entered Part 1 and answered the purchase question
[2]
Completed are the subjects who actually completed Part 1
Period Title: Disposition for Part 2
Started 964 [1] 153 [1]
Completed 754 [2] 127 [2]
Not Completed 210 26
Reason Not Completed
Physician Decision             25             7
Adverse Event             36             5
Lost to Follow-up             76             7
Withdrawal by Subject             60             3
Investigator decision             0             1
Other than specified above             13             3
[1]
Started are subjects who purchased study product and are eligible to enter Part-2 of study.
[2]
Completed are the subjects who completed use phase Part-2 (Week 24 and EOS-P2 interviews).
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks). Cohort 2 included all men who were currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks). Total of all reporting groups
Overall Number of Baseline Participants 1731 362 2093
Hide Baseline Analysis Population Description
Analysis Set for Cohort 1 and 2: This set included all men who were currently not using a prescription medicine for BPH (Cohort 1) or were currently using a prescription medicine for BPH (Cohort 2) and who answered the purchase question in Part 1. (Age is missing for 8 men)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1731 participants 362 participants 2093 participants
61.8  (11.67) 68.3  (9.10) 63.0  (11.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1731 participants 362 participants 2093 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
1731
 100.0%
362
 100.0%
2093
 100.0%
1.Primary Outcome
Title Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product and do Not Stop Use or Initiate Contact With Doctor Out of Total Population in Cohort 1
Hide Description Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the Drug Facts Label (DFL) within the first 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set for Actual Use (FAS-AU1) included all men who were currently not using a prescription medicine for BPH, purchased the study product, took at least one dose of study drug within the first 12 weeks of purchase and participated in at least 1 phone interview within the first 12 weeks of using the study product.
Arm/Group Title Cohort 1
Hide Arm/Group Description:
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
Overall Number of Participants Analyzed 924
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.2
(0.0 to 0.8)
2.Secondary Outcome
Title Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL During the Study (24 Weeks) and do Not Stop Use or Initiate Contact With a Doctor Out of the Total Population in Cohort 1
Hide Description Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL during the study (i.e., 24 weeks) and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS AU1
Arm/Group Title Cohort 1
Hide Arm/Group Description:
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
Overall Number of Participants Analyzed 924
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.2
(0.0 to 0.8)
3.Secondary Outcome
Title Percentage of Men Who Report Condition Listed Under "Stop Use and Ask a Doctor if" Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 12 Weeks
Hide Description Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 12 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set for Actual Use and Stop Use and Ask If – Condition Within the First 12 Weeks: (FAS-AU1-COND12): These populations are subsets of the FAS-AU1 population which will include all men who report a condition listed under the “Stop use and ask a doctor if” section of DFL within the first 12 weeks of using the study product.
Arm/Group Title Cohort 1
Hide Arm/Group Description:
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
Overall Number of Participants Analyzed 207
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
1.0
(0.1 to 3.4)
4.Secondary Outcome
Title Percentage of Men Who Report Condition Listed Under "Stop Use and Ask a Doctor if" Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 24 Weeks
Hide Description Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 24 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 24 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set for Actual Use and Stop Use and Ask If – Condition Within the First 24 Weeks: (FAS-AU1-COND24): These populations are subsets of the FAS-AU1 population which will include all men who report a condition listed under the “Stop use and ask a doctor if” section of DFL within the first 24 weeks of using the study product.
Arm/Group Title Cohort 1
Hide Arm/Group Description:
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
Overall Number of Participants Analyzed 215
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.9
(0.1 to 3.3)
5.Secondary Outcome
Title Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product Out of the Total Population in Cohort 1
Hide Description Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within the first 12 weeks of using the study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS AU1
Arm/Group Title Cohort 1
Hide Arm/Group Description:
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
Overall Number of Participants Analyzed 924
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
22.4
(19.8 to 25.2)
6.Secondary Outcome
Title Percentage of Men Who Report at Baseline a Symptom or Condition Under the "Ask A Doctor Before Use" Section of the DFL and Initiate Contact With a Doctor Out of the Total Population in Cohort 1
Hide Description Percentage of men who reported at baseline a symptom or condition under the "Ask A Doctor Before Use" section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS AU1
Arm/Group Title Cohort 1
Hide Arm/Group Description:
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
Overall Number of Participants Analyzed 924
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
20.3
(17.8 to 23.1)
7.Secondary Outcome
Title Percentage of Men Who Report at Baseline a Symptom or Condition Under the "Ask A Doctor Before Use" Section of the DFL and Initiate Contact With a Doctor Out of the Total Population of Cohort 1 Who Report a Symptom or Condition
Hide Description Percentage of men who reported at baseline a symptom or condition under the "Ask A Doctor Before Use" section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 who reported a symptom or condition is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set for Actual Use and Ask a Doctor Before Use (FAS-AU1-ASK) is a subset of the FAS-AU1 population which included all men who reported a symptom or condition listed under the “Ask a doctor before use” section of the DFL.
Arm/Group Title Cohort 1
Hide Arm/Group Description:
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
Overall Number of Participants Analyzed 223
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
84.3
(78.9 to 88.8)
8.Secondary Outcome
Title Percentage of Men Who Seek the Advice of a Physician Within the First 12/24 Weeks of the Study Out of the Total Population in Cohort 1
Hide Description Percentage of men who sought advice of a physician within the first 12/24 weeks of the study out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS AU1
Arm/Group Title Cohort 1
Hide Arm/Group Description:
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
Overall Number of Participants Analyzed 924
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 12 (N=924)
43.1
(39.9 to 46.3)
Week 24 (N=924)
56.4
(53.1 to 59.6)
9.Secondary Outcome
Title Percentage of Men Who Took Two or More Capsules Per Day Within the First 12/24 Weeks of Using Study Product Out of the Total Population in Cohort 1
Hide Description Percentage of men who took two or more capsules per day within the first 12/24 weeks of using study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS AU1
Arm/Group Title Cohort 1
Hide Arm/Group Description:
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
Overall Number of Participants Analyzed 924
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 12 (N=924)
7.6
(6.3 to 10.0)
Week 24 (N=924)
9.5
(8.1 to 12.1)
Time Frame From the first drug administration until 3 days after the treatment phase, up to 171 days.
Adverse Event Reporting Description The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
 
Arm/Group Title Cohort 1 Cohort 2 Cohort 1 and 2
Hide Arm/Group Description Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks). (TS1) Cohort 2 included all men who were currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks). (TS2) Cohort 1 and 2 included all men who answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks) regardless of whether they were currently using the product or not. (TS)
All-Cause Mortality
Cohort 1 Cohort 2 Cohort 1 and 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Cohort 1 Cohort 2 Cohort 1 and 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   54/927 (5.83%)   12/150 (8.00%)   66/1077 (6.13%) 
Cardiac disorders       
Atrial flutter  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Cardiac failure congestive  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Cardiomyopathy  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Cardiovascular disorder  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Coronary artery disease  1  1/927 (0.11%)  1/150 (0.67%)  2/1077 (0.19%) 
Coronary artery occlusion  1  1/927 (0.11%)  1/150 (0.67%)  2/1077 (0.19%) 
Myocardial infarction  1  2/927 (0.22%)  1/150 (0.67%)  3/1077 (0.28%) 
Eye disorders       
Glaucoma  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Retinal detachment  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Gastrointestinal disorders       
Intestinal obstruction  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Small intestinal obstruction  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
General disorders       
Chest pain  1  2/927 (0.22%)  1/150 (0.67%)  3/1077 (0.28%) 
Immune system disorders       
Hypersensitivity  1  0/927 (0.00%)  1/150 (0.67%)  1/1077 (0.09%) 
Infections and infestations       
Anal abscess  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Appendicitis perforated  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Bacteraemia  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Cellulitis  1  0/927 (0.00%)  1/150 (0.67%)  1/1077 (0.09%) 
Influenza  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Pneumonia  1  1/927 (0.11%)  1/150 (0.67%)  2/1077 (0.19%) 
Pneumonia bacterial  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Respiratory tract infection  1  0/927 (0.00%)  1/150 (0.67%)  1/1077 (0.09%) 
Sepsis  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Sinusitis  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Injury, poisoning and procedural complications       
Craniocerebral injury  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Femur fracture  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Jaw fracture  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Tendon rupture  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion  1  0/927 (0.00%)  1/150 (0.67%)  1/1077 (0.09%) 
Osteoarthritis  1  2/927 (0.22%)  0/150 (0.00%)  2/1077 (0.19%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  2/927 (0.22%)  0/150 (0.00%)  2/1077 (0.19%) 
Bladder cancer  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Chronic lymphocytic leukaemia  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Colon cancer  1  2/927 (0.22%)  0/150 (0.00%)  2/1077 (0.19%) 
Hepatic cancer  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Lung neoplasm malignant  1  0/927 (0.00%)  1/150 (0.67%)  1/1077 (0.09%) 
Malignant melanoma  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Pancreatic carcinoma  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Prostate cancer  1  2/927 (0.22%)  1/150 (0.67%)  3/1077 (0.28%) 
Skin cancer  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Squamous cell carcinoma  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Throat cancer  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Nervous system disorders       
Carotid artery disease  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Cerebrovascular accident  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Ischaemic stroke  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Seizure  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Transient ischaemic attack  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Psychiatric disorders       
Anxiety  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Renal and urinary disorders       
Calculus urinary  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  0/927 (0.00%)  1/150 (0.67%)  1/1077 (0.09%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Dyspnoea  1  2/927 (0.22%)  0/150 (0.00%)  2/1077 (0.19%) 
Respiratory arrest  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Skin and subcutaneous tissue disorders       
Diabetic ulcer  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Surgical and medical procedures       
Hospitalisation  1  2/927 (0.22%)  0/150 (0.00%)  2/1077 (0.19%) 
Vascular disorders       
Aortic aneurysm  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Deep vein thrombosis  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Hypertension  1  2/927 (0.22%)  0/150 (0.00%)  2/1077 (0.19%) 
Hypotension  1  1/927 (0.11%)  1/150 (0.67%)  2/1077 (0.19%) 
Orthostatic hypotension  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Peripheral arterial occlusive disease  1  1/927 (0.11%)  0/150 (0.00%)  1/1077 (0.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 Cohort 2 Cohort 1 and 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   61/927 (6.58%)   25/150 (16.67%)   86/1077 (7.99%) 
Infections and infestations       
Nasopharyngitis  1  48/927 (5.18%)  17/150 (11.33%)  65/1077 (6.04%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  15/927 (1.62%)  8/150 (5.33%)  23/1077 (2.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02573311    
Other Study ID Numbers: 527.85
First Submitted: October 1, 2015
First Posted: October 9, 2015
Results First Submitted: March 12, 2020
Results First Posted: April 8, 2020
Last Update Posted: April 8, 2020