Trial Outcomes & Findings for Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan) (NCT NCT00666276)

NCT ID: NCT00666276

Last Updated: 2012-07-02

Results Overview

The adverse drug reaction that have not been listed in Japanese package insert.

• Recruitment status: COMPLETED
• Target enrollment: 1004 participants
• Primary outcome timeframe: Baseline to 8 weeks
• Results posted on: 2012-07-02

Participant Flow

This was an open label, prospective, multi-center non-interventional cohort study.

Participant milestones

Measure	Linezolid Participants who have been treated with Linezolid.
Overall Study STARTED	1004
Overall Study COMPLETED	970
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Measure	Linezolid Participants who have been treated with Linezolid.
Overall Study Protocol Violation	34

Baseline Characteristics

Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)

Baseline characteristics by cohort

Measure	Linezolid n=970 Participants Participants who have been treated with Linezolid.
Age, Customized <65 years	282 participants n=5 Participants
Age, Customized >=65 years	688 participants n=5 Participants
Sex: Female, Male Female	308 Participants n=5 Participants
Sex: Female, Male Male	662 Participants n=5 Participants
Target disease Sepsis	192 participants n=5 Participants
Target disease Deep-seated skin infection	33 participants n=5 Participants
Target disease Secondary infection in injury, Burn and operative	136 participants n=5 Participants
Target disease Pneumonia	377 participants n=5 Participants
Target disease Multiple infection	141 participants n=5 Participants
Target disease Other	91 participants n=5 Participants
Target disease Severity Mild	68 participants n=5 Participants
Target disease Severity Moderate	455 participants n=5 Participants
Target disease Severity Severe	447 participants n=5 Participants
Complications Present	897 participants n=5 Participants
Complications Absent	73 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.

The adverse drug reaction that have not been listed in Japanese package insert.

Outcome measures

Measure	Linezolid n=970 Participants Participants who have been treated with Linezolid.	Linezolid-female Female participants who have been treated with Linezolid.	Linezolid-oral From Injection Participants with who have been treated with Linezolid by orally from injection .
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. Superinfection	1 participants	—	—
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. Sepsis	1 participants	—	—
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. Thrombocytopenia	1 participants	—	—
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. Lactic acidosis	1 participants	—	—
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. Agitation	1 participants	—	—
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. Deep vein thrombosis	1 participants	—	—
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. Hyperbilirubinaemia	1 participants	—	—
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. Antithrombin III decreased	1 participants	—	—
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. Blood chloride increased	1 participants	—	—
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. Blood sodium increased	1 participants	—	—

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.

All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Adverse Drug Reactions were evaluated in company with the causal relationship to the investigational product.

Outcome measures

Measure	Linezolid n=970 Participants Participants who have been treated with Linezolid.	Linezolid-female Female participants who have been treated with Linezolid.	Linezolid-oral From Injection Participants with who have been treated with Linezolid by orally from injection .
Number of Participants With Adverse Drug Reactions(ADRs).	163 participants	—	—

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.

Number of participants with adverse drug reaction to determine whether male or female is significant risk factor.

Outcome measures

Measure	Linezolid n=662 Participants Participants who have been treated with Linezolid.	Linezolid-female n=308 Participants Female participants who have been treated with Linezolid.	Linezolid-oral From Injection Participants with who have been treated with Linezolid by orally from injection .
Factors Considered to Affect the Safety of Linezolid - Gender.	109 participants	54 participants	—

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.

Number of participants with adverse drug reaction to determine whether over 65 or less than 65 is significant risk factor.

Outcome measures

Measure	Linezolid n=688 Participants Participants who have been treated with Linezolid.	Linezolid-female n=282 Participants Female participants who have been treated with Linezolid.	Linezolid-oral From Injection Participants with who have been treated with Linezolid by orally from injection .
Factors Considered to Affect the Safety of Linezolid - Age	122 participants	41 participants	—

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.

Number of participants with or without Hepatic dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.

Outcome measures

Measure	Linezolid n=856 Participants Participants who have been treated with Linezolid.	Linezolid-female n=114 Participants Female participants who have been treated with Linezolid.	Linezolid-oral From Injection Participants with who have been treated with Linezolid by orally from injection .
Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions.	137 participants	26 participants	—

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.

Number of participants with or without Renal dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.

Outcome measures

Measure	Linezolid n=765 Participants Participants who have been treated with Linezolid.	Linezolid-female n=205 Participants Female participants who have been treated with Linezolid.	Linezolid-oral From Injection Participants with who have been treated with Linezolid by orally from injection .
Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions.	125 participants	38 participants	—

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.

Number of participants with Duration of drug administration as over 15 days or less than 15 days with adverse drug reaction to determine whether over 15 days or less than 15 days is significant risk factor.

Outcome measures

Measure	Linezolid n=203 Participants Participants who have been treated with Linezolid.	Linezolid-female n=767 Participants Female participants who have been treated with Linezolid.	Linezolid-oral From Injection Participants with who have been treated with Linezolid by orally from injection .
Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration.	53 participants	110 participants	—

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.

Number of participants Route of administration as by oral,injection or oral from injection with adverse drug reaction to determine whether oral, injection or switch is significant risk factor.

Outcome measures

Measure	Linezolid n=132 Participants Participants who have been treated with Linezolid.	Linezolid-female n=768 Participants Female participants who have been treated with Linezolid.	Linezolid-oral From Injection n=70 Participants Participants with who have been treated with Linezolid by orally from injection .
Factors Considered to Affect the Safety of Linezolid - Route of Administration.	29 participants	116 participants	18 participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.

Number of participants Weight as over 40kg or less than 40kg with adverse drug reaction to determine whether over 40kg or less than 40kg Weight is significant risk factor.

Outcome measures

Measure	Linezolid n=651 Participants Participants who have been treated with Linezolid.	Linezolid-female n=96 Participants Female participants who have been treated with Linezolid.	Linezolid-oral From Injection Participants with who have been treated with Linezolid by orally from injection .
Factors Considered to Affect the Safety of Linezolid - Weight.	108 participants	20 participants	—

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.

Number of participants with or without Concomitant drugs with adverse drug reaction to determine whether with or without is significant risk factor.

Outcome measures

Measure	Linezolid n=97 Participants Participants who have been treated with Linezolid.	Linezolid-female n=873 Participants Female participants who have been treated with Linezolid.	Linezolid-oral From Injection Participants with who have been treated with Linezolid by orally from injection .
Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs.	9 participants	154 participants	—

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.

Number of participants with or without Non-drug therapies with adverse drug reaction to determine whether with or without is significant risk factor.

Outcome measures

Measure	Linezolid n=610 Participants Participants who have been treated with Linezolid.	Linezolid-female n=360 Participants Female participants who have been treated with Linezolid.	Linezolid-oral From Injection Participants with who have been treated with Linezolid by orally from injection .
Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies.	87 participants	76 participants	—

Adverse Events

Linezolid

Serious events: 50 serious events

Other events: 163 other events

Deaths: 0 deaths

Serious adverse events

Measure	Linezolid n=970 participants at risk Participants who have been treated with Linezolid.
Investigations Platelet count decreased	2.4% 23/970 • Number of events 23 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.
Blood and lymphatic system disorders Thrombocytopenia	1.0% 10/970 • Number of events 10 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.
Blood and lymphatic system disorders Anaemia	0.72% 7/970 • Number of events 7 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.
Blood and lymphatic system disorders Bone marrow failure	0.31% 3/970 • Number of events 3 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.
Blood and lymphatic system disorders Pancytopenia	0.31% 3/970 • Number of events 3 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 Haemoglobin decreased	0.31% 3/970 • Number of events 3 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 White blood cell count decreased	0.31% 3/970 • Number of events 3 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 Superinfection	0.21% 2/970 • Number of events 2 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 Haematocrit decreased	0.21% 2/970 • Number of events 2 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 Red blood cell count decreased	0.21% 2/970 • Number of events 2 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 Sepsis	0.10% 1/970 • Number of events 1 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.
Metabolism and nutrition disorders Lactic acidosis	0.10% 1/970 • Number of events 1 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.
Vascular disorders Deep vein thrombosis	0.10% 1/970 • Number of events 1 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 Diarrhoea	0.10% 1/970 • Number of events 1 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.
Hepatobiliary disorders Hyperbilirubinaemia	0.10% 1/970 • Number of events 1 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.

Other adverse events

Measure	Linezolid n=970 participants at risk Participants who have been treated with Linezolid.
Investigations Platelet count decreased	8.0% 78/970 • Number of events 78 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.
Blood and lymphatic system disorders Anaemia	3.2% 31/970 • Number of events 31 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.
Blood and lymphatic system disorders Thrombocytopenia	2.7% 26/970 • Number of events 26 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 White blood cell count decreased	1.2% 12/970 • Number of events 12 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.
Blood and lymphatic system disorders Bone marrow failure	0.82% 8/970 • Number of events 8 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.
Hepatobiliary disorders Hepatic function abnormal	0.62% 6/970 • Number of events 6 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 Superinfection	0.52% 5/970 • Number of events 5 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 Diarrhoea	0.52% 5/970 • Number of events 5 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.
Blood and lymphatic system disorders Pancytopenia	0.41% 4/970 • Number of events 4 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 Rash	0.41% 4/970 • Number of events 4 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 Drug eruption	0.41% 4/970 • Number of events 4 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 Haemoglobin decreased	0.41% 4/970 • Number of events 4 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.
Metabolism and nutrition disorders Decreased appetite	0.31% 3/970 • Number of events 3 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.
Metabolism and nutrition disorders Hyponatraemia	0.31% 3/970 • Number of events 3 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 Red blood cell count decreased	0.31% 3/970 • Number of events 3 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.
Metabolism and nutrition disorders Hyperkalaemia	0.21% 2/970 • Number of events 2 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.
Metabolism and nutrition disorders Hypochloraemia	0.21% 2/970 • Number of events 2 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 Haematocrit decreased	0.21% 2/970 • Number of events 2 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 bilirubin increased	0.21% 2/970 • Number of events 2 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 Pneumonia klebsiella	0.10% 1/970 • Number of events 1 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 Pseudomonas infection	0.10% 1/970 • Number of events 1 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 Sepsis	0.10% 1/970 • Number of events 1 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.
Metabolism and nutrition disorders Dehydration	0.10% 1/970 • Number of events 1 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.
Metabolism and nutrition disorders Lactic acidosis	0.10% 1/970 • Number of events 1 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 Agitation	0.10% 1/970 • Number of events 1 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.
Vascular disorders Deep vein thrombosis	0.10% 1/970 • Number of events 1 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 Reflux oesophagitis	0.10% 1/970 • Number of events 1 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 Enterocolitis	0.10% 1/970 • Number of events 1 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 Vomiting	0.10% 1/970 • Number of events 1 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.
Hepatobiliary disorders Liver disorder	0.10% 1/970 • Number of events 1 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.
Hepatobiliary disorders Hyperbilirubinaemia	0.10% 1/970 • Number of events 1 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 Aspartate aminotransferase increased	0.10% 1/970 • Number of events 1 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 Alanine aminotransferase increased	0.10% 1/970 • Number of events 1 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 Antithrombin III decreased	0.10% 1/970 • Number of events 1 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 Liver function test abnormal	0.10% 1/970 • Number of events 1 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 chloride increased	0.10% 1/970 • Number of events 1 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 sodium increased	0.10% 1/970 • Number of events 1 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 glucose increased	0.10% 1/970 • Number of events 1 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 urea increased	0.10% 1/970 • Number of events 1 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 White blood cell count increased	0.10% 1/970 • Number of events 1 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 Reticulocyte count decreased	0.10% 1/970 • Number of events 1 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

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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