ENTER10: Amlodipine 10mg Drug Use Investigation

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01252563
• Collaborator: (none)
• Enrollment: 14,141
• Actual Duration (Months): 22

Study Details

Study Description

Brief Summary

In this survey, to collect the safety and efficacy information in the subjects who have been treated with amlodipine 5mg at least 4 weeks in daily practice.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Amlodipine

Detailed Description

All the subjects whom an investigator prescribes Amlodipine (Norvasc®) 10mg Tablet should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Study Design

• Study Type: Observational
• Actual Enrollment: 14141 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: NORVASC10MG DRUG USE INVESTIGATION
• Actual Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Amlodipine 10mg Tablet Subjects taking Amlodipine 10mg Tablet.	Drug: Amlodipine; Usual adult dosage is 2.5-5 mg of amlodipine given orally as a single daily dose. Dosage should be adjusted depending on the patient's symptoms. The dose can be raised up to 10 mg once daily for patients who show inadequate response.; Other Names: Norvasc

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Related Adverse Events [Last day of observation period (average of 14.76 weeks)]

   A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.).

2. The Achievement Rate to Ambulatory Blood Pressure Goal [4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)]

   The achievement rates to ambulatory blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.

3. Changes in Ambulatory Systolic Blood Pressure From Baseline [4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)]

   Changes in ambulatory systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.

4. Changes in Ambulatory Diastolic Blood Pressure From Baseline [4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)]

   Changes in ambulatory diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.

Secondary Outcome Measures

1. Number of Participants With Adverse Events Listed in Japanese Package Insert [Last day of observation period (average of 14.76 weeks)]

   Adverse events refer to all events undesirable for participants that occur after the start of treatment with Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day, regardless of presence/absence of causal relationship with Amlodipine Tablets or Amlodipine OD Tablets (including clinically significant abnormal changes in laboratory test values).

2. Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert [Last day of observation period (average of 14.76 weeks)]

   A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.).

3. Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s) [Last day of observation period (average of 14.76 weeks)]

   To determine whether having complication(s) was a significant risk factor likely to affect the frequency of treatment-related adverse events. Complications included dyslipidemia, diabetes mellitus, metabolic syndrome, chronic kidney disease, angina pectoris, cerebrovascular disease, and myocardial infarction.

4. Number of Participants With Treatment-Related Adverse Events: Male vs. Female [Last day of observation period (average of 14.76 weeks)]

   To determine whether gender was a significant risk factor likely to affect the frequency of treatment-related adverse events.

5. Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris) [Last day of observation period (average of 14.76 weeks)]

   To determine whether having angina pectoris as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events.

6. Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia) [Last day of observation period (average of 14.76 weeks)]

   To determine whether having dyslipidaemia as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events.

7. Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive) [Last day of observation period (average of 14.76 weeks)]

   To determine whether receiving antihypertensive as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events.

8. Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB) [Last day of observation period (average of 14.76 weeks)]

   To determine whether receiving ARB as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events.

9. Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus) [Last day of observation period (average of 14.76 weeks)]

   To determine whether having diabetes mellitus as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.

10. Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease) [Last day of observation period (average of 14.76 weeks)]

    To determine whether having chronic kidney disease as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.

11. Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction) [Last day of observation period (average of 14.76 weeks)]

    To determine whether having myocardial infarction as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.

12. Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome) [Last day of observation period (average of 14.76 weeks)]

    To determine whether having metabolic syndrome as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.

13. Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure [Last day of observation period (average of 14.76 weeks)]

    To determine whether ambulatory systolic blood pressure at baseline was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.

14. The Achievement Rate to Home Blood Pressure Goal [4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)]

    The achievement rates to home blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.

15. Changes in Home Systolic Blood Pressure From Baseline [4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)]

    Changes in home systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.

16. Changes in Home Diastolic Blood Pressure From Baseline [4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)]

    Changes in home diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female subjects who have been treated with amlodipine 5mg at least 4 weeks

• The subjects who had not achieved target BP

Exclusion Criteria:

• Subjects who have been prescribed amlodipine (Norvasc®) 10mg Tablet before

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT01252563
• Other Study ID Numbers: A0531097
• First Posted: Dec 3, 2010
• Last Update Posted: Jan 28, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: ENTER10; Hypertension; Japanese; Norvasc 10mg; Post Marketing surveillance
• Additional relevant MeSH terms: Hypertension; Amlodipine

Study Results

Participant Flow

Pre-assignment Detail	A total of 14141 participants were registered in the study. Of the 14141 participants, 366 participants were excluded from the study because their case report forms were not collected, mainly due to the lack of cooperation from the investigators. Finally, 13775 participants were included in the study.

Arm/Group Title	Amlodipine 10 mg Tablet
Arm/Group Description	Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
Period Title: Overall Study
STARTED	13775
COMPLETED	13343
NOT COMPLETED	432

Baseline Characteristics

Arm/Group Title	Amlodipine 10 mg Tablet
Arm/Group Description	Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
Overall Participants	13343
Age, Customized (Number) [Number]
<65 years	5229 39.2%
>=65 years	8114 60.8%
Sex/Gender, Customized (Count of Participants)
Female	5839 43.8%
Male	7504 56.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Related Adverse Events
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.

Arm/Group Title	Amlodipine 10 mg Tablet
Arm/Group Description	Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
Measure Participants	13343
Number [participants]	208 1.6%

2. Primary Outcome

Title	The Achievement Rate to Ambulatory Blood Pressure Goal
Description	The achievement rates to ambulatory blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.
Time Frame	4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.

Arm/Group Title	The Achievement Rate to Ambulatory Blood Pressure Goal
Arm/Group Description	The achievement rates to ambulatory blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.
Measure Participants	13124
Week 4	35.1 0.3%
Week 8	40.1 0.3%
Week 12	43.9 0.3%
Last Day	43.9 0.3%

3. Primary Outcome

Title	Changes in Ambulatory Systolic Blood Pressure From Baseline
Description	Changes in ambulatory systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.
Time Frame	4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.

Arm/Group Title	Changes in Ambulatory SBP From Baseline
Arm/Group Description	changes in ambulatory SBP from baseline at weeks 4, 8, and 12 as well as on the last day of the observation period.
Measure Participants	13124
Week 4	-16.8 (15.20)
Week 8	-18.4 (15.90)
Week 12	-19.9 (16.05)
Last Day	-20.1 (16.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Week 4
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Week 8
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Week 12
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Last Day
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

4. Primary Outcome

Title	Changes in Ambulatory Diastolic Blood Pressure From Baseline
Description	Changes in ambulatory diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.
Time Frame	4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.

Arm/Group Title	Changes in Ambulatory DBP From Baseline
Arm/Group Description	changes in ambulatory DBP from baseline at weeks 4, 8, and 12 as well as on the last day of the observation period.
Measure Participants	13124
Week 4	-8.2 (10.47)
Week 8	-9.1 (10.75)
Week 12	-9.9 (11.03)
Last Day	-10.0 (11.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Week 4
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Week 8
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Week 12
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Last Day
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

5. Secondary Outcome

Title	Number of Participants With Adverse Events Listed in Japanese Package Insert
Description	Adverse events refer to all events undesirable for participants that occur after the start of treatment with Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day, regardless of presence/absence of causal relationship with Amlodipine Tablets or Amlodipine OD Tablets (including clinically significant abnormal changes in laboratory test values).
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.

Arm/Group Title	Amlodipine 10 mg Tablet
Arm/Group Description	Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
Measure Participants	13343
Number [participants]	566 4.2%

6. Secondary Outcome

Title	Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.

Arm/Group Title	Amlodipine 10 mg Tablet
Arm/Group Description	Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
Measure Participants	13343
Number [Events]	21

7. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s)
Description	To determine whether having complication(s) was a significant risk factor likely to affect the frequency of treatment-related adverse events. Complications included dyslipidemia, diabetes mellitus, metabolic syndrome, chronic kidney disease, angina pectoris, cerebrovascular disease, and myocardial infarction.
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.

Arm/Group Title	With Complication(s)	Without Complication(s)
Arm/Group Description	Participants who had at least one complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.	Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
Measure Participants	9177	4166
Number [Participants]	170 1.3%	38 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet, Without Complication(s)
	Comments	The risk factor tested was "Complication". The null hypothesis was that there was no difference between participants with complication(s) and participants without complication in the frequency of treatment-related adverse events.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

8. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events: Male vs. Female
Description	To determine whether gender was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.

Arm/Group Title	Male	Female
Arm/Group Description	Male participants who experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.	Female participants who experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
Measure Participants	7504	5839
Number [Participants]	87 0.7%	121 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet, Without Complication(s)
	Comments	The risk factor tested was "Gender". The null hypothesis was that there was no difference between male and female in the frequency of treatment-related adverse events.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

9. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris)
Description	To determine whether having angina pectoris as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.

Arm/Group Title	With Angina Pectoris	Without Angina Pectoris
Arm/Group Description	Participants who had angina pectoris as a complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.	Participants who had no angina pectoris as a complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
Measure Participants	872	12471
Number [Participants]	21 0.2%	187 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet, Without Complication(s)
	Comments	The risk factor tested was "angina pectoris" as a complication. The null hypothesis was that there was no difference between participants with angina pectoris and participants without angina pectoris in the frequency of treatment-related adverse events.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.036
	Comments
	Method	Chi-squared
	Comments

10. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia)
Description	To determine whether having dyslipidaemia as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.

Arm/Group Title	With Dyslipidaemia	Without Dyslipidaemia
Arm/Group Description	Participants who had dyslipidaemia as a complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.	Participants who had no dyslipidaemia as a complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
Measure Participants	5308	8035
Number [Participants]	99 0.7%	109 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet, Without Complication(s)
	Comments	The risk factor tested was "dyslipidaemia" as a complication. The null hypothesis was that there was no difference between participants with dyslipidaemia and participants without dyslipidaemia in the frequency of treatment-related adverse events.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.020
	Comments
	Method	Chi-squared
	Comments

11. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive)
Description	To determine whether receiving antihypertensive as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.

Arm/Group Title	With Antihypertensive	Without Antihypertensive
Arm/Group Description	Participants who received antihypertensive as a concomitant drug and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.	Participants who received no antihypertensive as a concomitant drug and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
Measure Participants	7834	5509
Number [Participants]	136 1%	72 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet, Without Complication(s)
	Comments	The risk factor tested was "antihypertensive" as a concomitant drug. The null hypothesis was that there was no difference between participants receiving antihypertensive and participants receiving no antihypertensive in the frequency of treatment-related adverse events.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.049
	Comments
	Method	Chi-squared
	Comments

12. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB)
Description	To determine whether receiving ARB as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.

Arm/Group Title	With ARB	Without ARB
Arm/Group Description	Participants who received ARB as a concomitant drug and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.	Participants who received no ARB as a concomitant drug and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
Measure Participants	6641	6702
Number [Participants]	118 0.9%	90 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet, Without Complication(s)
	Comments	The risk factor tested was "ARB" as a concomitant drug. The null hypothesis was that there was no difference between participants receiving ARB and participants receiving no ARB in the frequency of treatment-related adverse events.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.043
	Comments
	Method	Chi-squared
	Comments

13. Secondary Outcome

Title	Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus)
Description	To determine whether having diabetes mellitus as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.

Arm/Group Title	With Diabetes Mellitus	Without Diabetes Mellitus
Arm/Group Description	Participants with diabetes mellitus as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.	Participants without diabetes mellitus as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
Measure Participants	2247	7004
Number [Participants]	52 0.4%	892 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet, Without Complication(s)
	Comments	The risk factor tested was "diabetes mellitus" as a complication. The null hypothesis was that there was no difference between participants with diabetes mellitus and participants without diabetes mellitus in the efficacy.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

14. Secondary Outcome

Title	Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease)
Description	To determine whether having chronic kidney disease as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.

Arm/Group Title	With Chronic Kidney Disease	Without Chronic Kidney Disease
Arm/Group Description	Participants with chronic kidney disease as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.	Participants without chronic kidney disease as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
Measure Participants	1034	8217
Number [Participants]	24 0.2%	920 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet, Without Complication(s)
	Comments	The risk factor tested was "chronic kidney disease" as a complication. The null hypothesis was that there was no difference between participants with chronic kidney disease and participants without chronic kidney disease in the efficacy.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

15. Secondary Outcome

Title	Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction)
Description	To determine whether having myocardial infarction as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.

Arm/Group Title	With Myocardial Infarction	Without Myocardial Infarction
Arm/Group Description	Participants with myocardial infarction as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.	Participants without myocardial infarction as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
Measure Participants	55	9196
Number [Participants]	1 0%	943 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet, Without Complication(s)
	Comments	The risk factor tested was "myocardial infarction" as a complication. The null hypothesis was that there was no difference between participants with myocardial infarction and participants without myocardial infarction in the efficacy.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.039
	Comments
	Method	Chi-squared
	Comments

16. Secondary Outcome

Title	Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome)
Description	To determine whether having metabolic syndrome as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.

Arm/Group Title	With Metabolic Syndrome	Without Metabolic Syndrome
Arm/Group Description	Participants with metabolic syndrome as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.	Participants without metabolic syndrome as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
Measure Participants	1716	7535
Number [Participants]	92 0.7%	852 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet, Without Complication(s)
	Comments	The risk factor tested was "metabolic syndrome" as a complication. The null hypothesis was that there was no difference between participants with metabolic syndrome and participants without metabolic syndrome in the efficacy.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

17. Secondary Outcome

Title	Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure
Description	To determine whether ambulatory systolic blood pressure at baseline was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.
Time Frame	Last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.

Arm/Group Title	<120 mmHg at Baseline	120 to 140 mmHg at Baseline	140 to 160 mmHg at Baseline	160 to 180 mmHg at Baseline	>= 180 mmHg at Baseline
Arm/Group Description	Participants with ambulatory SBP of below 120 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.	Participants with ambulatory SBP of 120 to 140 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.	Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.	Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.	Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
Measure Participants	82	863	4675	2808	757
Number [Participants]	19 0.1%	171 NaN	543 NaN	182 NaN	26 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet, Without Complication(s), 140 to 160 mmHg at Baseline, 160 to 180 mmHg at Baseline, >= 180 mmHg at Baseline
	Comments	The risk factor tested was "ambulatory SBP at baseline". The null hypothesis was that there was no association between ambulatory SBP at baseline and the number of participants who achieved the target blood pressure specified in the guidelines.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

18. Secondary Outcome

Title	The Achievement Rate to Home Blood Pressure Goal
Description	The achievement rates to home blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.
Time Frame	4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.

Arm/Group Title	The Achievement Rate to Home Blood Pressure Goal
Arm/Group Description	The achievement rates to home blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.
Measure Participants	13124
Week 4	21.2 0.2%
Week 8	27.9 0.2%
Week 12	32.2 0.2%
Last Day	31.3 0.2%

19. Secondary Outcome

Title	Changes in Home Systolic Blood Pressure From Baseline
Description	Changes in home systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.
Time Frame	4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.

Arm/Group Title	Changes in Home SBP From Baseline
Arm/Group Description	Mean changes in home SBP from baseline at weeks 4, 8, and 12 as well as on the last day of the observation period.
Measure Participants	13124
Week 4	-15.7 (13.34)
Week 8	-18.0 (13.80)
Week 12	-19.9 (14.38)
Last Day	-19.6 (14.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Week 4
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Week 8
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Week 12
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Last Day
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

20. Secondary Outcome

Title	Changes in Home Diastolic Blood Pressure From Baseline
Description	Changes in home diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.
Time Frame	4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

Outcome Measure Data

Analysis Population Description

The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.

Arm/Group Title	Changes in Home Diastolic Blood Pressure From Baseline
Arm/Group Description	Mean changes in home DBP from baseline at weeks 4, 8, and 12 as well as on the last day of the observation period.
Measure Participants	13124
Week 4	-8.3 (9.21)
Week 8	-9.5 (9.46)
Week 12	-10.4 (10.07)
Last Day	-10.4 (9.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Week 4
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Week 8
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Week 12
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 10 mg Tablet
	Comments	The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Last Day
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Adverse Events

Adverse Event Reporting Description	The frequency of adverse events during the study.
Arm/Group Title	Amlodipine 10 mg Tablet
Arm/Group Description	Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
All Cause Mortality
	Amlodipine 10 mg Tablet
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Amlodipine 10 mg Tablet
	Affected / at Risk (%)	# Events
Total	78/13343 (0.6%)
Cardiac disorders
Cardiac failure	6/13343 (0%)	6
Angina pectoris	3/13343 (0%)	3
Atrial fibrillation	3/13343 (0%)	3
Cardiac failure congestive	1/13343 (0%)	1
Prinzmetal angina	1/13343 (0%)	1
Cardiac failure acute	2/13343 (0%)	2
Myocardial infarction	1/13343 (0%)	1
Cardiac failure chronic	1/13343 (0%)	1
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/13343 (0%)	1
Pancreatitis acute	1/13343 (0%)	1
Ascites	1/13343 (0%)	1
Aphagia	1/13343 (0%)	1
General disorders
Malaise	1/13343 (0%)	1
Death	1/13343 (0%)	1
Generalised oedema	1/13343 (0%)	1
Oedema peripheral	1/13343 (0%)	1
Hepatobiliary disorders
Hepatic failure	1/13343 (0%)	1
Infections and infestations
Enteritis infectious	1/13343 (0%)	1
Meningitis	1/13343 (0%)	1
Pneumonia	7/13343 (0.1%)	7
Injury, poisoning and procedural complications
Traumatic lung injury	1/13343 (0%)	1
Hand fracture	1/13343 (0%)	1
Upper limb fracture	1/13343 (0%)	1
Metabolism and nutrition disorders
Marasmus	1/13343 (0%)	1
Diabetes mellitus	1/13343 (0%)	1
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis	1/13343 (0%)	1
Osteoporosis	1/13343 (0%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant	1/13343 (0%)	1
Uterine cancer	1/13343 (0%)	1
Oesophageal carcinoma	1/13343 (0%)	1
Intracranial haemangioma	1/13343 (0%)	1
Pancreatic carcinoma	1/13343 (0%)	1
Nervous system disorders
Cerebral infarction	7/13343 (0.1%)	7
Epilepsy	1/13343 (0%)	1
Loss of consciousness	1/13343 (0%)	1
Carotid artery stenosis	1/13343 (0%)	1
VIIth nerve paralysis	1/13343 (0%)	1
Subarachnoid haemorrhage	2/13343 (0%)	2
Ruptured cerebral aneurysm	1/13343 (0%)	1
Convulsion	1/13343 (0%)	1
Transient ischaemic attack	2/13343 (0%)	2
Cerebral haemorrhage	2/13343 (0%)	2
Renal and urinary disorders
Nephrotic syndrome	1/13343 (0%)	1
Renal failure acute	1/13343 (0%)	1
Azotaemia	1/13343 (0%)	1
Renal disorder	1/13343 (0%)	1
Renal cyst haemorrhage	1/13343 (0%)	1
Renal failure	2/13343 (0%)	2
Pollakiuria	1/13343 (0%)	1
Renal failure chronic	1/13343 (0%)	1
Respiratory, thoracic and mediastinal disorders
Pleural effusion	1/13343 (0%)	1
Pneumonia aspiration	2/13343 (0%)	2
Pulmonary congestion	1/13343 (0%)	1
Emphysema	1/13343 (0%)	1
Pulmonary oedema	1/13343 (0%)	1
Skin and subcutaneous tissue disorders
Photosensitivity reaction	1/13343 (0%)	1
Vascular disorders
Deep vein thrombosis	1/13343 (0%)	1
Aortic aneurysm rupture	1/13343 (0%)	1
Hypotension	1/13343 (0%)	1
Peripheral arterial occlusive disease	1/13343 (0%)	1
Other (Not Including Serious) Adverse Events
	Amlodipine 10 mg Tablet
	Affected / at Risk (%)	# Events
Total	250/13343 (1.9%)
Gastrointestinal disorders
Gastrooesophageal reflux disease	15/13343 (0.1%)	15
Constipation	16/13343 (0.1%)	16
General disorders
Oedema	14/13343 (0.1%)	14
Oedema peripheral	85/13343 (0.6%)	85
Infections and infestations
Bronchitis	17/13343 (0.1%)	17
Investigations
Blood pressure decreased	23/13343 (0.2%)	23
Metabolism and nutrition disorders
Diabetes mellitus	22/13343 (0.2%)	22
Nervous system disorders
Headache	14/13343 (0.1%)	14
Dizziness	45/13343 (0.3%)	45
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	14/13343 (0.1%)	14

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.