Trial Outcomes & Findings for Benign Prostatic Hyperplasia (BPH) Screening Tool Case Finding Study in Subjects >=50 Years (NCT NCT02757963)

Results Overview

Confirmed diagnosis of BPH was based on full urologist diagnostic testing with a positive result on the BPE/BPO screening tool (score \>=3) and serum PSA \>=2 ng/mL. The BPE/BPO questionnaire consists of three questions each with a score ranging from 0= never experienced to 5= almost always experienced. Participants with probable BPH underwent full urologist diagnostic testing, which included review of medical history, symptoms and previous tests, brief physical examination, Digital rectal examination (DRE). Proportion of participants was calculated by dividing number of participants with a positive result on the BPE/BPO screening tool (Score \>= 3) and a diagnosis of BPH by the urologist (Numerator) by number of participants with a positive result on the BPE/BPO screening tool (Score \>= 3) and a BPH assessment by the urologist (Denominator). 95% confidence interval on the proportion was calculated by using the exact (Clopper-Pearson) method.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1679 participants

Primary outcome timeframe

Up to 6 weeks

Results posted on

2021-01-05

Participant Flow

A total of 1658 male participants, \>=50 years of age, with reasons not related to lower urinary tract symptoms (LUTS) were included in evaluable Population. The study was conducted at 47 centers in 5 countries; 8 centers in France, 9 centers in Germany, 6 centers in Italy, 18 centers in Russia and 6 centers in Spain.

A total of 2343 male participants were screened for probable Benign prostatic hyperplasia (BPH). Of these, 1679 participants were enrolled, 1658 participants were included in the evaluable population. 21 participants progressed in the study but were found to have not met eligibility criteria. Overall, 561 participants completed all 3 visits.

Participant milestones

Participant milestones
Measure	IPSS >=8 or BPE/BPO >=3 Participants were screened using the Benign prostatic enlargement (BPE)/ benign prostatic obstruction (BPO) and International Prostate Symptom Score (IPSS) screening tools. Participants with positive responses (i.e. met entry criteria, including positive IPSS score \>= 8 and/or BPE/BPO score \>= 3) were enrolled and proceeded to Part I (GP Assessment). Participants with probable BPH \[PSA\>= 2 Nano gram per milliliter (ng/mL)\] proceeded to Part II and were scheduled for a urologist assessment which was to confirm or refute a diagnosis of BPH and to estimate whether the participant is at risk of progression of BPH.
Overall Study STARTED	1658
Overall Study COMPLETED	561
Overall Study NOT COMPLETED	1097

Reasons for withdrawal

Reasons for withdrawal
Measure	IPSS >=8 or BPE/BPO >=3 Participants were screened using the Benign prostatic enlargement (BPE)/ benign prostatic obstruction (BPO) and International Prostate Symptom Score (IPSS) screening tools. Participants with positive responses (i.e. met entry criteria, including positive IPSS score \>= 8 and/or BPE/BPO score \>= 3) were enrolled and proceeded to Part I (GP Assessment). Participants with probable BPH \[PSA\>= 2 Nano gram per milliliter (ng/mL)\] proceeded to Part II and were scheduled for a urologist assessment which was to confirm or refute a diagnosis of BPH and to estimate whether the participant is at risk of progression of BPH.
Overall Study Adverse Event	3
Overall Study Reached Stopping Criteria	1054
Overall Study Lost to Follow-up	5
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	34

Baseline Characteristics

Race information was not collected for 99 participants who were enrolled in the study in France.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IPSS >=8 or BPE/BPO >=3 n=1658 Participants Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses (i.e. met entry criteria, including positive IPSS score \>=8 and/or BPE/BPO score \>=3) were enrolled and proceeded to Part I (GP Assessment). Participants with probable BPH (PSA\>=2 ng/mL) proceeded to Part II and were scheduled for a urologist assessment which was to confirm or refute a diagnosis of BPH and to estimate whether the participant is at risk of progression of BPH.
Age, Continuous	62.8 Years STANDARD_DEVIATION 8.26 • n=1658 Participants
Sex: Female, Male Female	0 Participants n=1658 Participants
Sex: Female, Male Male	1658 Participants n=1658 Participants
Race/Ethnicity, Customized African American/African Heritage	2 Participants n=1559 Participants • Race information was not collected for 99 participants who were enrolled in the study in France.
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	2 Participants n=1559 Participants • Race information was not collected for 99 participants who were enrolled in the study in France.
Race/Ethnicity, Customized White - Arabic/ North African Heritage	2 Participants n=1559 Participants • Race information was not collected for 99 participants who were enrolled in the study in France.
Race/Ethnicity, Customized White - White/ Caucasian/European Heritage	1550 Participants n=1559 Participants • Race information was not collected for 99 participants who were enrolled in the study in France.
Race/Ethnicity, Customized White - Mixed Race	1 Participants n=1559 Participants • Race information was not collected for 99 participants who were enrolled in the study in France.
Race/Ethnicity, Customized Mixed Race	2 Participants n=1559 Participants • Race information was not collected for 99 participants who were enrolled in the study in France.

PRIMARY outcome

Timeframe: Up to 6 weeks

Population: All Evaluable Subject Population comprised of all participants who meet the entry criteria, including a positive IPSS screening result (score \>=8) and/or a positive BPE/BPO screening result (score \>=3).

Confirmed diagnosis of BPH was based on full urologist diagnostic testing with a positive result on the BPE/BPO screening tool (score \>=3) and serum PSA \>=2 ng/mL. The BPE/BPO questionnaire consists of three questions each with a score ranging from 0= never experienced to 5= almost always experienced. Participants with probable BPH underwent full urologist diagnostic testing, which included review of medical history, symptoms and previous tests, brief physical examination, Digital rectal examination (DRE). Proportion of participants was calculated by dividing number of participants with a positive result on the BPE/BPO screening tool (Score \>= 3) and a diagnosis of BPH by the urologist (Numerator) by number of participants with a positive result on the BPE/BPO screening tool (Score \>= 3) and a BPH assessment by the urologist (Denominator). 95% confidence interval on the proportion was calculated by using the exact (Clopper-Pearson) method.

Outcome measures

Outcome measures
Measure	BPE/BPO >=3 n=1249 Participants Participants were screened using the BPE/ BPO screening tools. Participants with a positive response to this tool (i.e. Participants met entry criteria, including a positive BPE/BPO score \>= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA\>= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 and BPE/BPO >=3 Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>=8 and BPE/BPO score \>=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 or BPE/BPO >=3 Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>=8 or BPE/BPO score \>=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 or BPE/BPO >=3 Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>= 8 or BPE/BPO score \>= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
Number of Men With Confirmed Diagnosis of BPH Numerator	386 Participants	—	—	—
Number of Men With Confirmed Diagnosis of BPH Denominator	437 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: All Evaluable Subjects Population

Confirmed diagnosis of BPH was based on full urologist diagnostic testing with a positive result on the IPSS, BPE/BPO and IPSS, BPE/BPO or IPSS screening tools and serum PSA \>=2 ng/mL. The BPE/BPO questionnaire consists of three questions each with a score ranging from 0= never experienced to 5= almost always experienced. IPSS tool is used to assess the severity of LUTS symptoms with a score ranging from 0= never experienced to 5= almost always experienced. Participants with probable BPH underwent full urologist diagnostic testing, which included review of medical history, symptoms and previous tests, brief physical examination, DRE. Proportion of participants was calculated by dividing number of participants with a positive result on the screening tool and a diagnosis of BPH by the urologist (Numerator) by number of participants with a positive result on the screening tool and a BPH assessment by the urologist(Denominator).

Outcome measures

Outcome measures
Measure	BPE/BPO >=3 n=1558 Participants Participants were screened using the BPE/ BPO screening tools. Participants with a positive response to this tool (i.e. Participants met entry criteria, including a positive BPE/BPO score \>= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA\>= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 and BPE/BPO >=3 n=1149 Participants Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>=8 and BPE/BPO score \>=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 or BPE/BPO >=3 n=1658 Participants Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>=8 or BPE/BPO score \>=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 or BPE/BPO >=3 Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>= 8 or BPE/BPO score \>= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
Number of Men That Are Confirmed to Have BPH Based on Full Urologist Assessment of Diagnostic Test Results Among Men With a Positive Result on the IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools and Serum PSA >=2 ng/mL Numerator	471 Participants	367 Participants	490 Participants	—
Number of Men That Are Confirmed to Have BPH Based on Full Urologist Assessment of Diagnostic Test Results Among Men With a Positive Result on the IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools and Serum PSA >=2 ng/mL Denominator	537 Participants	413 Participants	561 Participants	—

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: All Evaluable Subjects Population

Confirmed risk for BPH was based on full urologist diagnostic testing with a positive result on the BPE/BPO and/or IPSS screening tool and probable GP BPH diagnosis. The BPE/BPO questionnaire consists of 3 questions each with a score from 0= never experienced to 5= almost always experienced. IPSS tool is used to assess the severity of LUTS symptoms with a score from 0= never experienced to 5= almost always experienced. Participants with probable BPH underwent full urologist diagnostic testing, which included review of medical history, symptoms and previous tests, physical examination, DRE. Participants with PSA \>=2.0 ng/mL and other tests were considered as at risk for BPH. Proportion of participants was calculated by dividing number of participants with a positive result on the screening tool and diagnosis of BPH progression risk (Numerator) by number of participants with a positive result on the screening tool and a BPH progression risk assessment by the urologist (Denominator).

Outcome measures

Outcome measures
Measure	BPE/BPO >=3 n=1558 Participants Participants were screened using the BPE/ BPO screening tools. Participants with a positive response to this tool (i.e. Participants met entry criteria, including a positive BPE/BPO score \>= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA\>= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 and BPE/BPO >=3 n=1249 Participants Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>=8 and BPE/BPO score \>=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 or BPE/BPO >=3 n=1149 Participants Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>=8 or BPE/BPO score \>=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 or BPE/BPO >=3 n=1658 Participants Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>= 8 or BPE/BPO score \>= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
Number of Men That Are Confirmed to be at Risk for BPH Progression Based Upon Full Urologist Assessment Among Men With a Positive Result on the BPE/BPO, IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools and Serum PSA >=2 ng/mL Numerator	424 Participants	350 Participants	333 Participants	441 Participants
Number of Men That Are Confirmed to be at Risk for BPH Progression Based Upon Full Urologist Assessment Among Men With a Positive Result on the BPE/BPO, IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools and Serum PSA >=2 ng/mL Denominator	471 Participants	386 Participants	367 Participants	490 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: All Evaluable Subjects Population

Diagnosis of probable BPH was based on GP assessment among men with a positive result on the BPE/BPO and/or IPSS screening tool. The BPE/BPO questionnaire consists of 3 questions each with a score from 0= never experienced to 5= almost always experienced. IPSS tool is used to assess the severity of LUTS symptoms with a score from 0= never experienced to 5= almost always experienced. Probable BPH is the presumptive diagnosis of urinary tract obstruction from an enlarged prostate based on clinical symptoms and findings where urinary symptoms are not apparently related to any other cause. Participants underwent GP assessment and lab result review by GP. Participants with PSA \>=2 ng/mL were assessed for probable BPH. Proportion of participants was calculated by dividing number of participants with a positive result on the screening tool and diagnosis of probable BPH (Numerator) by number of participants with a positive result on the screening tool and a BPH assessment by GP (Denominator).

Outcome measures

Outcome measures
Measure	BPE/BPO >=3 n=1558 Participants Participants were screened using the BPE/ BPO screening tools. Participants with a positive response to this tool (i.e. Participants met entry criteria, including a positive BPE/BPO score \>= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA\>= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 and BPE/BPO >=3 n=1249 Participants Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>=8 and BPE/BPO score \>=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 or BPE/BPO >=3 n=1149 Participants Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>=8 or BPE/BPO score \>=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 or BPE/BPO >=3 n=1658 Participants Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>= 8 or BPE/BPO score \>= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
Number of Men That Are Diagnosed With Probable BPH as Assessed by the GP Among Men With a Positive Result on the BPE/BPO, IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools Numerator	556 Participants	453 Participants	428 Participants	581 Participants
Number of Men That Are Diagnosed With Probable BPH as Assessed by the GP Among Men With a Positive Result on the BPE/BPO, IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools Denominator	1538 Participants	1232 Participants	1135 Participants	1635 Participants

SECONDARY outcome

Timeframe: Day 1

Population: All Screened Subjects Population comprised of all participants who were screened for eligibility. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Agreement between the IPSS and BPE/BPO tools had to utilize the screened population, as the evaluable population did not include any participants with IPSS \<8 and BPE/BPO\<3. All screened participants with IPSS and BPE/BPO results were utilized (2327 of the 2343 participants had IPSS and BPE/PO results). There were 16 participants (2343 minus 2327) in the screened population without IPSS and BPE/BPO results, and hence were not included in the calculation of the Kappa statistic. Kappa statistic values of \<0 were characterized as no agreement, 0 to 0.20 as slight, 0.21 to 0.40 as fair, 0.41 to 0.60 as moderate, 0.61 to 0.80 as substantial, and 0.81 to 1.00 as almost perfect agreement. The 95% confidence interval for the Kappa statistic is based on the asymptotic standard error.

Outcome measures

Outcome measures
Measure	BPE/BPO >=3 n=2327 Participants Participants were screened using the BPE/ BPO screening tools. Participants with a positive response to this tool (i.e. Participants met entry criteria, including a positive BPE/BPO score \>= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA\>= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 and BPE/BPO >=3 Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>=8 and BPE/BPO score \>=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 or BPE/BPO >=3 Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>=8 or BPE/BPO score \>=3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>=2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH	IPSS >=8 or BPE/BPO >=3 Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>= 8 or BPE/BPO score \>= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
Summary of Agreement Between BPE/BPO and IPSS Screening Tools	1812 Participants	—	—	—

Adverse Events

IPSS >= 8 or BPE/BPO >= 3

Serious events: 9 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	IPSS >= 8 or BPE/BPO >= 3 n=1658 participants at risk Participants were screened using the BPE/BPO and IPSS screening tools. Participants with positive responses to these tools (i.e. Participants met entry criteria, including a positive IPSS score \>= 8 or BPE/BPO score \>= 3) were enrolled and proceeded to Part I (GP Assessment) of the study. Participants with probable BPH (PSA \>= 2 ng/mL) proceeded to Part II and were scheduled for the urologist assessment to confirm diagnosis of BPH and to estimate whether the participant was at risk of progression of BPH
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.36% 6/1658 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening (Visit 1) through 6 weeks On-therapy SAEs and non-serious AEs are reported for members of All Evaluable Subjects Population which comprised of all participants who met the entry criteria, including a positive IPSS screening result (score \>=8) and/or a positive BPE/BPO screening result (score \>=3)
Cardiac disorders Atrial flutter	0.06% 1/1658 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening (Visit 1) through 6 weeks On-therapy SAEs and non-serious AEs are reported for members of All Evaluable Subjects Population which comprised of all participants who met the entry criteria, including a positive IPSS screening result (score \>=8) and/or a positive BPE/BPO screening result (score \>=3)
Cardiac disorders Myocardial infarction	0.06% 1/1658 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening (Visit 1) through 6 weeks On-therapy SAEs and non-serious AEs are reported for members of All Evaluable Subjects Population which comprised of all participants who met the entry criteria, including a positive IPSS screening result (score \>=8) and/or a positive BPE/BPO screening result (score \>=3)
General disorders Sudden death	0.06% 1/1658 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening (Visit 1) through 6 weeks On-therapy SAEs and non-serious AEs are reported for members of All Evaluable Subjects Population which comprised of all participants who met the entry criteria, including a positive IPSS screening result (score \>=8) and/or a positive BPE/BPO screening result (score \>=3)

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER