Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01072539
• Collaborator: (none)
• Enrollment: 3,172
• Locations: 36
• Duration (Months): 59
• Patients Per Site: 88.1
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events. And the secondary objective is to evaluate clinical response in the clinically evaluable population at test-of cure (TOC) or at the end of treatment (EOT) assessment, and microbiologic response at the subject level, if available.

Condition or Disease	Intervention/Treatment	Phase
Complicated Skin and Skin Structure Infections; Complicated Intra-abdominal Infections; Community-Acquired Bacterial Pneumonia	Drug: tigecycline

Detailed Description

Prior to the conduct of this study, the investigator will explain the study objective, etc to prospective subjects on the basis of "explanatory material." The informed consent will be obtained in written form by each subject voluntarily.

Study Design

• Study Type: Observational
• Actual Enrollment: 3172 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Patients who have approved indications of Tygacil Approved indications of Tygacil -complicated intraabdominal infection, complicated skin and skin structure infection, community-acquired bacterial pneumonia	Drug: tigecycline; As prescribed by physician in usual clinical practice; Other Names: Tygacil

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs [From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.]

   All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer.

2. Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics [From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.]

   Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (<65 years or >=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications.

Secondary Outcome Measures

1. Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment [At the TOC or EOT assessment]

   Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil .

2. Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site [At the TOC or EOT assessment]

   Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil .

3. Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase) [At the TOC or EOT assessment]

   Definitions: Eradication: None of the baseline isolates were present in a repeat culture taken from the original site of infection (documented) or a clinical response of cure precluded the availability of a specimen for culture (presumed). Persistence: Any baseline isolates were present in a repeat culture obtained from the original site of infection (documented) or culture data were not available for a participant with a clinical response of failure (presumed). Unevaluable: participants who died during therapy for non-infection-related reasons, died for any reason within 2 days after first administration of Tygacil, were lost to follow-up (ie, clinical response was not able to be assessed), or had no baseline isolates.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :

Adults 18 years of age or older, who have one of the followings:

• Complicated skin and skin structure infections

• Complicated intra-abdominal infections

• Community-acquired bacterial pneumonia

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

• Patients who have known hypersensitivity to tigecycline

• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou University Hospital	Suwon	Gyeonggi-do	Korea, Republic of	443-380
2	Pusan National University Yangsan Hospital	Yangsan-si	Gyeongnam	Korea, Republic of	626-770
3	Gachon University Gil Hospital	Namdong-gu	Incheon	Korea, Republic of	405-760
4	Wonkwang University Hospital	Iksan-si	Jeollabuk-do	Korea, Republic of	573-250
5	Chonbuk National University Hospital	Jeonju	Jeollabuk-do	Korea, Republic of	561-712
6	Hanil Medical Center	Dobong-Gu	Seoul	Korea, Republic of	132-033
7	Kosin University Gospel Hospital	Busan		Korea, Republic of	602-702
8	Dong-A University Medical Center (Dong-A University Hospital)	Busan		Korea, Republic of	602-715
9	Cheongju St. Mary's Hospital	Cheongju-si		Korea, Republic of	363-568
10	Keimyung University Dongsan Medical Center (KUDMC)	Daegu		Korea, Republic of	700-712
11	Kyungpook National University Hospital (KNUH)	Daegu		Korea, Republic of	700-721
12	Daegu fatima hospital	Daegu		Korea, Republic of	701-724
13	Yeungnam University Medical Center	Daegu		Korea, Republic of	705-717
14	Daegu Catholic University Medical Center (DCUMC)	Daegu		Korea, Republic of	705-718
15	Korea University Ansan Hospital	Gyeonggi-do		Korea, Republic of	425-707
16	Ajou University Hospital	Gyeonggi-do		Korea, Republic of	443-721
17	Inha University Hospital	Incheon		Korea, Republic of	400-711
18	Gachon University Gil Hospital	Incheon		Korea, Republic of	405-760
19	Jeju National University Hospital	Jeju		Korea, Republic of	690-767
20	Yonsei University Wonju College of Medicine- Wonju Christian Hospital	Kangwon-do		Korea, Republic of	220-701
21	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
22	Yonsei University College of Medicine Severance Hospital Rheumatology Internal Medicine	Seoul		Korea, Republic of	120752
23	Kyunghee University Medical Hospital	Seoul		Korea, Republic of	130-702
24	Hallym University Kangdong Sacred Heart Hospital	Seoul		Korea, Republic of	134-701
25	Kyung Hee University Hospital at Gangdong	Seoul		Korea, Republic of	134-727
26	Kangdong Sacred Heart Hospital	Seoul		Korea, Republic of	134-814
27	Samsung Medical Center	Seoul		Korea, Republic of	135-710
28	Korea University Anam Hospital	Seoul		Korea, Republic of	136-705
29	Asan Medical Center, University of Ulsan	Seoul		Korea, Republic of	138-736
30	Asan Medical Center	Seoul		Korea, Republic of	138-736
31	Eulji Medical Center	Seoul		Korea, Republic of	139-711
32	Hallym University Kangnam Sacred Heart Hospital	Seoul		Korea, Republic of	150-950
33	Hallym University Medical Center (HUMC) - Kangnam Sacred Heart Hospital	Seoul		Korea, Republic of	150-950
34	Korea University Guro Hospital	Seoul		Korea, Republic of	152-703
35	Kangbuk Samsung Medical Center	Seoul		Korea, Republic of
36	Ulsan University Hospital	Ulsan		Korea, Republic of	682-714

Sponsors and Collaborators

• Pfizer

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
• ClinicalTrials.gov Identifier: NCT01072539
• Other Study ID Numbers: 3074X1-4527; B1811040
• First Posted: Feb 22, 2010
• Last Update Posted: May 30, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Pfizer: infection; Tygacil; PMS
• Additional relevant MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections; Pneumonia, Bacterial; Tigecycline

Study Results

Participant Flow

Recruitment Details	Participants were enrolled between May 2010 and April 2015 from Korean health care centers.

Arm/Group Title	Tygacil
Arm/Group Description	Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Period Title: Overall Study
STARTED	3172
COMPLETED	3169
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Tygacil
Arm/Group Description	Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Overall Participants	3169
Age, Customized (Number) [Number]
<30 years	126 4%
30 to 39 years	200 6.3%
40 to 49 years	346 10.9%
50 to 64 years	1116 35.2%
>=65 years	1381 43.6%
Sex: Female, Male (Count of Participants)
Female	1089 34.4%
Male	2080 65.6%
Infection Site (Number) [Number]
cSSSI	976 30.8%
cIAI	1947 61.4%
CAP	242 7.6%
cIAI + cSSSI	2 0.1%
cIAI + CAP	2 0.1%
Severity of Infection (Number) [Number]
Mild	287 9.1%
Moderate	2072 65.4%
Severe	810 25.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs
Description	All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer.
Time Frame	From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.

Outcome Measure Data

Analysis Population Description

Safety Anaysis Set

Arm/Group Title	Tygacil
Arm/Group Description	Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Measure Participants	3169
AEs	32.98 1%
ADRs	9.85 0.3%
SAEs	13.22 0.4%
SADRs	0.13 0%
Unexpected AEs	8.24 0.3%
Unexpected ADRs	0.44 0%

2. Secondary Outcome

Title	Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment
Description	Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil .
Time Frame	At the TOC or EOT assessment

Outcome Measure Data

Analysis Population Description

Effectiveness Analysis Set: Participants who received at least one dose of Tygacil and had related effectiveness endpoints evaluated at least.

Arm/Group Title	Tygacil
Arm/Group Description	Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Measure Participants	2545
Prospectively Collected Data	59.68 1.9%
Retrospectively Collected Data	74.97 2.4%
Total	71.59 2.3%

3. Secondary Outcome

Title	Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site
Description	Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil .
Time Frame	At the TOC or EOT assessment

Outcome Measure Data

Analysis Population Description

Effectiveness Analysis Set.

Arm/Group Title	Tygacil
Arm/Group Description	Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Measure Participants	2545
Infection Site: cSSSI	77.53 2.4%
Infection Site: cIAI	71.52 2.3%
Infection Site: CAP	45.35 1.4%
Infection Site: cIAI + cSSSI	0.00 0%
Infection Site: cIAI + CAP	50.00 1.6%
Infection Site: Total	71.59 2.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	Comparison among subgroups of Infection Sites: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical significant level: 0.05
	Method	Fisher Exact
	Comments

4. Primary Outcome

Title	Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics
Description	Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (<65 years or >=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications.
Time Frame	From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.

Outcome Measure Data

Analysis Population Description

Safety Analysis Set.

Arm/Group Title	Tygacil
Arm/Group Description	Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Measure Participants	3169
Prospectively Collected Data	34.15 1.1%
Retrospectively Collected Data	32.62 1%
Geriatric: <65 Years	30.98 1%
Geriatric: >=65 Years	35.55 1.1%
Age: <30 Years	30.16 1%
Age: 40 to 49 Yeas	27.46 0.9%
Age: 50 to 64 Years	31.99 1%
Age: >=65 Years	35.55 1.1%
Sex: Male	32.55 1%
Sex: Female	33.79 1.1%
Duration of Disease: <3 Months	32.88 1%
Duration of Disease: >=3 Months and <6 Months	33.63 1.1%
Duration of Disease: >=6 Months	32.20 1%
Infection Site: cSSSI	28.79 0.9%
Infection Site: cIAI	34.87 1.1%
Infection Site: CAP	34.30 1.1%
Infection Site: cIAI + cSSSI	50.00 1.6%
Infection Site: cIAI + CAP	50.00 1.6%
Severity of Infection: Mild	26.83 0.8%
Severity of Infection: Moderate	27.27 0.9%
Severity of Infection: Severe	49.75 1.6%
General Medical History: Yes	34.91 1.1%
General Medical History: No	6.48 0.2%
General Medical History (Present): Yes	35.03 1.1%
General Medical History (Present): No	9.45 0.3%
General Medical History (Past): Yes	37.10 1.2%
General Medical History (Past): No	31.00 1%
Kidney Disorder: Yes	46.86 1.5%
Kidney Disorder: No	29.69 0.9%
Liver Disorder: Yes	39.82 1.3%
Liver Disorder: No	30.20 1%
Total Treatment Period of Tygacil: <7 Days	34.74 1.1%
Total Treatment Period of Tygacil: 7 to 14 Days	29.94 0.9%
Total Treatment Period of Tygacil: >14 Days	34.99 1.1%
Mean Daily Dose of Tygacil: <50 mg	100.00 3.2%
Mean Daily Dose of Tygacil: 50 to <100 mg	39.92 1.3%
Mean Daily Dose of Tygacil: 100 to <200 mg	30.57 1%
Mean Daily Dose of Tygacil: >=200 mg	60.00 1.9%
Past Medication and Therapy: Yes	33.48 1.1%
Past Medication and Therapy: No	27.02 0.9%
Concomitant Medications: Yes	33.77 1.1%
Concomitant Medications: No	14.06 0.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	Geriatrc: <65 Years Versus (VS) Geriatrc: >=65 Years
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0067
	Comments	Statistical significant level: 0.05
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	Comparison among Age categories: <30 Years, 30 to 39 Years, 40 to 49 Years, 50 to 64 Years, and >=65 Years.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0412
	Comments	Statistical significant level: 0.05
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	Sex: Male VS Sex: Female
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4792
	Comments	Statistical significant level: 0.05
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	Comparson among Duration of Disease categories: <3 Months, >=3 Months and <6 Months, and >=6 Months
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9669
	Comments	Statistical significant level: 0.05
	Method	Chi-squared
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	Comparison among subgroups of infection site: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0064
	Comments	Statistical significant level: 0.05
	Method	Fisher Exact
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	Comparison among severity of infection subgroups: Mild, Moderate, and Severe.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Satistical significant level: 0.05
	Method	Chi-squared
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	General Medical History: Yes VS General Medical History: No
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical significant level: 0.05
	Method	Chi-squared
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	General Medical History (Present): Yes VS General Medical History (Present): No
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical significant level: 0.05
	Method	Chi-squared
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	General Medical History (Past): Yes VS General Medical History (Past): No
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments	Statistical significant level: 0.05
	Method	Chi-squared
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	Kidney Disorder: Yes VS Kidney Disorder: No
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	Liver Disorder: Yes VS Liver Disorder: No
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical significant level: 0.05
	Method	Chi-squared
	Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	Comparison among subgroups of Total Treatment Period of Tygacil: <7 Days, 7 to 14 Days, and >14 Days
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0153
	Comments	Statistical significant level: 0.05
	Method	Chi-squared
	Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	Comparison among subgroups of Mean Daily Dose of Tygacil: <50 mg, 50 to <100 mg, 100 to <200 mg, and >=200 mg.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical significant level 0.05
	Method	Fisher Exact
	Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	Past Medication and Therapy: Yes VS Past Medication and Therapy: No
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0376
	Comments	Statistical significant level: 0.05
	Method	Chi-squared
	Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tygacil
	Comments	Concomitant Medications: Yes VS Concomitant Medications: No
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical significant level: 0.05
	Method	Chi-squared
	Comments

5. Secondary Outcome

Title	Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase)
Description	Definitions: Eradication: None of the baseline isolates were present in a repeat culture taken from the original site of infection (documented) or a clinical response of cure precluded the availability of a specimen for culture (presumed). Persistence: Any baseline isolates were present in a repeat culture obtained from the original site of infection (documented) or culture data were not available for a participant with a clinical response of failure (presumed). Unevaluable: participants who died during therapy for non-infection-related reasons, died for any reason within 2 days after first administration of Tygacil, were lost to follow-up (ie, clinical response was not able to be assessed), or had no baseline isolates.
Time Frame	At the TOC or EOT assessment

Outcome Measure Data

Analysis Population Description

Effectiveness Analysis Set from the prospective study phase; n refers to the total munber of participants who had evaluable data.

Arm/Group Title	Tygacil
Arm/Group Description	Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Measure Participants	563
Eradication (Documented or Presumed) (n=514)	46.69 1.5%
Persistence (Documented or Presumed) (n=514)	32.68 1%
Unevaluable (n=514)	20.62 0.7%

Adverse Events

Time Frame	From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.
Adverse Event Reporting Description	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.
Arm/Group Title	Tygacil
Arm/Group Description	Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
All Cause Mortality
	Tygacil
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Tygacil
	Affected / at Risk (%)	# Events
Total	419/3169 (13.2%)
Blood and lymphatic system disorders
Coagulation disorder	1/3169 (0%)
Disseminated intravascular coagulation	5/3169 (0.2%)
Haemorrhage not otherwise specified	1/3169 (0%)
Thrombocytopenia	8/3169 (0.3%)
Leucopenia	1/3169 (0%)
Leukocytosis	1/3169 (0%)
Marrow depression	6/3169 (0.2%)
Pancytopenia	1/3169 (0%)
Cardiac disorders
Cardiac failure	5/3169 (0.2%)
Arrhythmia	2/3169 (0.1%)
Bradycardia	1/3169 (0%)
Cardiac arrest	4/3169 (0.1%)
Fibrillation atrial	3/3169 (0.1%)
Fibrillation ventricular	1/3169 (0%)
Sick sinus syndrome	1/3169 (0%)
Cardiomyopathy	1/3169 (0%)
Myocardial infarction	4/3169 (0.1%)
Myocardial ischaemia	1/3169 (0%)
Gastrointestinal disorders
Clostridial infection	1/3169 (0%)
Colitis	1/3169 (0%)
Colitis pseudomembranous	1/3169 (0%)
Gastric ulcer haemorrhagic	1/3169 (0%)
Gastrointestinal haemorrhage	2/3169 (0.1%)
Intestinal fistula	1/3169 (0%)
Intestinal ischaemia	1/3169 (0%)
Intestinal perforation	1/3169 (0%)
Melaena	2/3169 (0.1%)
Pancreatitis	3/3169 (0.1%)
General disorders
Exacerbation of disease	1/3169 (0%)
Mediastinitis	2/3169 (0.1%)
Multiple organ failure	33/3169 (1%)
Hepatobiliary disorders
Bilirubinaemia	2/3169 (0.1%)
Cholangitis	3/3169 (0.1%)
Cholelithiasis	1/3169 (0%)
Hepatic cirrhosis	5/3169 (0.2%)
Hepatic failure	11/3169 (0.3%)
Hepatic function abnormal	1/3169 (0%)
Hepatitis	1/3169 (0%)
Hepatocellular damage	1/3169 (0%)
Hepatorenal syndrome	3/3169 (0.1%)
Jaundice	2/3169 (0.1%)
Serum glutamic oxaloacetic transaminase increased	3/3169 (0.1%)
Serum glutamic pyruvate transaminase increased	2/3169 (0.1%)
Immune system disorders
Graft versus host disease	1/3169 (0%)
Infections and infestations
Cellulitis	1/3169 (0%)
Abscess	8/3169 (0.3%)
Infection aggravated	3/3169 (0.1%)
Peritonitis	6/3169 (0.2%)
Sepsis	139/3169 (4.4%)
Injury, poisoning and procedural complications
Application site reaction	1/3169 (0%)
Wound dehiscence	1/3169 (0%)
Metabolism and nutrition disorders
Acidosis	1/3169 (0%)
Musculoskeletal and connective tissue disorders
Myositis	1/3169 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma small intestine	1/3169 (0%)
Leukaemia	1/3169 (0%)
Leukaemia granulocytic	4/3169 (0.1%)
Melanoma malignant	1/3169 (0%)
Neoplasm malignant	45/3169 (1.4%)
Sarcoma	1/3169 (0%)
Secondary carcinoma	1/3169 (0%)
Nervous system disorders
Brain hypoxia	2/3169 (0.1%)
Brain stem disorder	1/3169 (0%)
Carboxyhaemoglobinaemia	1/3169 (0%)
Convulsions	2/3169 (0.1%)
Oedema cerebral	1/3169 (0%)
Renal and urinary disorders
Azotaemia	3/3169 (0.1%)
Renal failure acute	10/3169 (0.3%)
Renal failure chronic	1/3169 (0%)
Renal failure chronic aggravated	8/3169 (0.3%)
Renal function abnormal	3/3169 (0.1%)
Pyelonephritis	1/3169 (0%)
Respiratory, thoracic and mediastinal disorders
Asphyxia	1/3169 (0%)
Asthma	1/3169 (0%)
Chronic obstructive airways disease	1/3169 (0%)
Dyspnoea	1/3169 (0%)
Hypoxia	1/3169 (0%)
Pneumonia	47/3169 (1.5%)
Pulmonary oedema	1/3169 (0%)
Respiratory depression	1/3169 (0%)
Respiratory distress syndrome	3/3169 (0.1%)
Respiratory insufficiency	7/3169 (0.2%)
Respiratory tract haemorrhage	1/3169 (0%)
Skin and subcutaneous tissue disorders
Diabetic ulcer	1/3169 (0%)
Stevens johnson syndrome	2/3169 (0.1%)
Surgical and medical procedures
Amputation	2/3169 (0.1%)
Surgical intervention	1/3169 (0%)
Vascular disorders
Circulatory failure	3/3169 (0.1%)
Hypotension	7/3169 (0.2%)
Cerebral haemorrhage	1/3169 (0%)
Cerebral infarction	1/3169 (0%)
Haematoma	2/3169 (0.1%)
Thrombophlebitis deep	1/3169 (0%)
Other (Not Including Serious) Adverse Events
	Tygacil
	Affected / at Risk (%)	# Events
Total	537/3169 (16.9%)
Blood and lymphatic system disorders
Thrombocytopenia	38/3169 (1.2%)
Gastrointestinal disorders
Diarrhoea	45/3169 (1.4%)
Nausea	170/3169 (5.4%)
Vomiting	42/3169 (1.3%)
Hepatobiliary disorders
Serum glutamic oxaloacetic transaminase increased	72/3169 (2.3%)
Serum glutamic pyruvate transaminase increased	62/3169 (2%)
Metabolism and nutrition disorders
Phosphatase alkaline increased	42/3169 (1.3%)
Renal and urinary disorders
Azotaemia	66/3169 (2.1%)

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.