Trial Outcomes & Findings for A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients (NCT NCT00852397)

Last Updated: 2013-08-29

Results Overview

Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. CRNM bleeding was acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

151 participants

Primary outcome timeframe

Week 0 to Week 24

Results posted on

2013-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 2.5 mg BID Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 5.0 mg BID Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Overall Study STARTED	52	49	50
Overall Study Treated Participants	51	49	49
Overall Study COMPLETED	41	41	36
Overall Study NOT COMPLETED	11	8	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 2.5 mg BID Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 5.0 mg BID Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Overall Study Adverse Event	4	6	4
Overall Study Death	0	0	1
Overall Study Withdrawal by Subject	4	1	2
Overall Study Study terminated by sponsor	2	1	6
Overall Study Difficulty in study site visit	1	0	0
Overall Study Protocol Violation	0	0	1

Baseline Characteristics

A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=52 Participants Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks. Number of participants in baseline characteristics means randomized participants.	Apixaban 2.5 mg BID n=49 Participants 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks. Number of participants in baseline characteristics means randomized participants.	Apixaban 5.0 mg BID n=50 Participants Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks. Number of participants in baseline characteristics means randomized participants.	Total n=151 Participants Total of all reporting groups
Age Continuous	63.9 years STANDARD_DEVIATION 10.1 • n=5 Participants	66.0 years STANDARD_DEVIATION 9.0 • n=7 Participants	64.0 years STANDARD_DEVIATION 9.2 • n=5 Participants	64.6 years STANDARD_DEVIATION 9.5 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	43 Participants n=7 Participants	46 Participants n=5 Participants	131 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 0 to Week 24

Population: Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 2.5 mg BID n=49 Participants Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 5.0 mg BID n=49 Participants Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Percentage of Participants Who Had Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major and Clinically-relevant Non-major (CRNM) Bleeding Events Occurring During the Treatment Period.	2.0 Percentage of Participants Interval 0.1 to 9.82	4.1 Percentage of Participants Interval 0.73 to 13.34	4.1 Percentage of Participants Interval 0.73 to 13.34

SECONDARY outcome

Timeframe: Week 0 to Week 24

All bleeding included major bleeding (including fatal bleeding), clinically-relevant non-major (CRNM) bleeding, and minor bleeding per international society on thrombosis and haemostasis (ISTH) definitions.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 2.5 mg BID n=49 Participants Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 5.0 mg BID n=49 Participants Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period.	33.3 Percentage of Participants Interval 20.76 to 47.23	38.8 Percentage of Participants Interval 26.01 to 53.76	44.9 Percentage of Participants Interval 30.83 to 59.77

SECONDARY outcome

Timeframe: Week 0 to Week 24

Major bleeding event was defined as an acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occured in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 2.5 mg BID n=49 Participants Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 5.0 mg BID n=49 Participants Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions.	0 Percentage of Participants Interval 0.0 to 6.31	2.0 Percentage of Participants Interval 0.1 to 10.24	4.1 Percentage of Participants Interval 0.73 to 13.34

SECONDARY outcome

Timeframe: Week 0 to Week 24

TIMI major bleeding event was difined as an intracranial bleeding or clinically overt bleeding (including bleeding evident on imaging studies) associated with a \>= 5 gm/dL fall in hemoglobin or a 15% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 2.5 mg BID n=49 Participants Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 5.0 mg BID n=49 Participants Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period.	0 Percentage of Participants Interval 0.0 to 6.31	2.0 Percentage of Participants Interval 0.1 to 10.24	2.0 Percentage of Participants Interval 0.1 to 10.24

SECONDARY outcome

Timeframe: For 30 days after Week 24 or the discontinuation of study drug

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 2.5 mg BID n=49 Participants Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 5.0 mg BID n=49 Participants Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction, Unstable Angina and Stroke During 30 Days After Discontinuation of Therapy.	0 Percentage of Participants Interval 0.0 to 6.31	0 Percentage of Participants Interval 0.0 to 6.53	2 Percentage of Participants Interval 0.1 to 10.24

SECONDARY outcome

Timeframe: From the day of randomization to the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time])

Population: The efficacy analysis set was all randomized participants.

Intended treatment period for efficacy endpoints was defined as a period starting on the day of randomization and ending at the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date \[19 November 2010, Japan time\]).

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 2.5 mg BID n=49 Participants Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 5.0 mg BID n=50 Participants Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction (MI), Unstable Angina, and Non-hemorrhagic Stroke Occurring During the Intended Treatment Period.	1.9 Percentage of Participants Interval 0.1 to 9.63	0 Percentage of Participants Interval 0.0 to 6.53	2.0 Percentage of Participants Interval 0.1 to 10.03

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 0 to Week 24

ISTH-defined CRNM bleeding was defined as an acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. ISTH defined minor bleeding event was defined as all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM bleeding were classified as minor bleeding.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 2.5 mg BID n=49 Participants Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 5.0 mg BID n=49 Participants Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period. ISTH defined CRNM	2.0 Percentage of Participants Interval 0.1 to 9.82	2.0 Percentage of Participants Interval 0.1 to 10.24	0 Percentage of Participants Interval 0.0 to 6.53
Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period. ISTH defined minor bleeding	31.4 Percentage of Participants Interval 19.63 to 45.07	36.7 Percentage of Participants Interval 23.64 to 51.64	40.8 Percentage of Participants Interval 27.0 to 55.79

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 0 to Week 24

TIMI minor bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) associated with a \>= 3 gm/dL fall in hemoglobin or a 9% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit). TIMI minimal bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) not meeting criteria for TIMI minor bleeding.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 2.5 mg BID n=49 Participants Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 5.0 mg BID n=49 Participants Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period. TIMI defined minor bleeding	0 Percentage of Participants Interval 0.0 to 6.31	2.0 Percentage of Participants Interval 0.0 to 6.53	2.0 Percentage of Participants Interval 0.1 to 10.24
Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period. TIMI defined minimal bleeding	33.3 Percentage of Participants Interval 20.76 to 47.23	38.8 Percentage of Participants Interval 26.01 to 53.76	40.8 Percentage of Participants Interval 27.0 to 55.79

Adverse Events

Placebo

Serious events: 8 serious events

Other events: 22 other events

Deaths: 0 deaths

Apixaban 2.5 mg BID

Serious events: 11 serious events

Other events: 28 other events

Deaths: 0 deaths

Apixaban 5.0 mg BID

Serious events: 7 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=51 participants at risk Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 2.5 mg BID n=49 participants at risk Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.	Apixaban 5.0 mg BID n=49 participants at risk Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Gastrointestinal disorders Diarrhoea	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.1% 3/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gingival bleeding	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.1% 3/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest discomfort	7.8% 4/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.2% 4/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	7.8% 4/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.2% 4/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.3% 8/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.1% 3/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Post procedural haemorrhage	11.8% 6/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.2% 6/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.2% 4/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood urine present	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.2% 4/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	5.9% 3/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	3.9% 2/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.1% 3/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	7.8% 4/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.1% 3/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.2% 4/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.9% 3/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	7.8% 4/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.2% 5/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.2% 6/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER