PROUD Study: A Prospective Study on the Usage Patterns of... | NCT00986102

ID	Type	Description	Link
DORIBAC4007	Other Identifier	Janssen Research & Development, LLC

Name	Class
Johnson & Johnson (Hong Kong) Ltd.	UNKNOWN

Label	Type	Description	Intervention Names
001	Other	doripenem 500mg vial by injection every 8 hours for 5 to 14 days	Drug: doripenem

Name	Type	Description	Arm Group Labels	Other Names
doripenem	Drug	500mg vial by injection every 8 hours for 5 to 14 days	001

Measure	Description	Time Frame
Number of Participants With the Usage of Doripenem as Per the Approved Indication	Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization	5 to 14 days
Number of Participants With Different Mode of Usage of Doripenem		5 to 14 days
Duration of Antibiotic Therapy	Duration of doripenem and duration of doripenem plus oral antibiotics therapy	5 to 14 days
Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score	APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 [less than or equal to 44] to 6 [greater than or equal to 75]) and C: chronic health points (2 [elective postoperative patient] and 5 [non-operative or emergency postoperative patient]). Total APACHE II score is sum of A, B and C.	Baseline (Day -1)

Measure	Description	Time Frame
Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)		Day 5 or Day 7 or Day 14
Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
24636429	Derived	Mustafa M, Chan WM, Lee C, Harijanto E, Loo CM, Van Kinh N, Anh ND, Garcia J. A PROspective study on the Usage patterns of Doripenem in the Asia-Pacific region (PROUD study). Int J Antimicrob Agents. 2014 Apr;43(4):353-60. doi: 10.1016/j.ijantimicag.2014.01.017. Epub 2014 Feb 15.

ID	Title	Description
FG000	Nosocomial Pneumonia (NP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
FG001	Ventilator-Associated Pneumonia (VAP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days

ID	Title	Description
BG000	Nosocomial Pneumonia (NP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
BG001	Ventilator-Associated Pneumonia (VAP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
BG002	Complicated Urinary Tract Infection (cUTI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
BG003	Complicated Intra-abdominal Infection (cIAI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00053 BG00177 BG00219 BG00367 BG004216

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With the Usage of Doripenem as Per the Approved Indication

Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization

Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.

Posted

Number

Participants

5 to 14 days

ID	Title	Description
OG000	Nosocomial Pneumonia (NP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG001	Ventilator-Associated Pneumonia (VAP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG002	Complicated Urinary Tract Infection (cUTI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
OG003	Complicated Intra-abdominal Infection (cIAI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days

Units	Counts
Participants	OG00053 OG00177 OG00219 OG003

Title

Denominators

Categories

Early onset of NP

Title	Measurements
	OG00023 OG0010 OG0020 OG003

Primary

Number of Participants With Different Mode of Usage of Doripenem

Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.

Posted

Number

Participants

5 to 14 days

ID	Title	Description
OG000	Nosocomial Pneumonia (NP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG001	Ventilator-Associated Pneumonia (VAP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG002	Complicated Urinary Tract Infection (cUTI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
OG003	Complicated Intra-abdominal Infection (cIAI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days

Primary

Duration of Antibiotic Therapy

Duration of doripenem and duration of doripenem plus oral antibiotics therapy

Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.

Posted

Mean

Standard Deviation

Days

5 to 14 days

ID	Title	Description
OG000	Nosocomial Pneumonia (NP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG001	Ventilator-Associated Pneumonia (VAP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG002	Complicated Urinary Tract Infection (cUTI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
OG003	Complicated Intra-abdominal Infection (cIAI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days

Primary

Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score

APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 [less than or equal to 44] to 6 [greater than or equal to 75]) and C: chronic health points (2 [elective postoperative patient] and 5 [non-operative or emergency postoperative patient]). Total APACHE II score is sum of A, B and C.

Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.

Posted

Number

Participants

Baseline (Day -1)

ID	Title	Description
OG000	Nosocomial Pneumonia (NP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG001	Ventilator-Associated Pneumonia (VAP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG002	Complicated Urinary Tract Infection (cUTI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days

Secondary

Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)

Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.

Posted

Number

Participants

Day 5 or Day 7 or Day 14

ID	Title	Description
OG000	Nosocomial Pneumonia (NP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG001	Ventilator-Associated Pneumonia (VAP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG002	Complicated Urinary Tract Infection (cUTI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
OG003	Complicated Intra-abdominal Infection (cIAI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days

Secondary

Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit

Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.

Posted

Number

Participants

End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days

ID	Title	Description
OG000	Nosocomial Pneumonia (NP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG001	Ventilator-Associated Pneumonia (VAP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG002	Complicated Urinary Tract Infection (cUTI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
OG003	Complicated Intra-abdominal Infection (cIAI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days

Secondary

Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit

Microbiological Modified Intent-to-Treat Population (mMITT): included participants who had a baseline pathogen identified, regardless of susceptibility to study medication.

Posted

Number

Participants

Day 5 or Day 7 or Day 14

ID	Title	Description
OG000	Nosocomial Pneumonia (NP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG001	Ventilator-Associated Pneumonia (VAP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG002	Complicated Urinary Tract Infection (cUTI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
OG003	Complicated Intra-abdominal Infection (cIAI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days

Secondary

Medical Resource Utilization

Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.

Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.

Posted

Median

Full Range

Days

From Baseline (Day -1) upto the duration of hospital stay of a participant

ID	Title	Description
OG000	Nosocomial Pneumonia (NP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG001	Ventilator-Associated Pneumonia (VAP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG002	Complicated Urinary Tract Infection (cUTI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
OG003	Complicated Intra-abdominal Infection (cIAI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days

Secondary

Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)

Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.

Posted

Number

Participants

Within 28 days after EOT (Day 5 or Day 7 or Day 14)

ID	Title	Description
OG000	Nosocomial Pneumonia (NP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG001	Ventilator-Associated Pneumonia (VAP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG002	Complicated Urinary Tract Infection (cUTI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
OG003	Complicated Intra-abdominal Infection (cIAI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days

Secondary

Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)

Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.

Posted

Number

Participants

Within 28 days after EOT (Day 5 or Day 7 or Day 14)

ID	Title	Description
OG000	Nosocomial Pneumonia (NP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG001	Ventilator-Associated Pneumonia (VAP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
OG002	Complicated Urinary Tract Infection (cUTI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
OG003	Complicated Intra-abdominal Infection (cIAI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG0030 events0 affected67 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Acute Coronary Syndrome	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Acute Myocardial Infarction	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0012 events2 affected77 at risk EG0020 events0 affected19 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Bradycardia	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0012 events2 affected77 at risk EG0020 events0 affected19 at risk EG003
Cardiac Arrest	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Cardiac Failure	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Cardiogenic Shock	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Mitral Valve Stenosis	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Right Ventricular Failure	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Tachycardia	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Gastric Ulcer Perforation	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Gastrointestinal Perforation	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Death	General disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Multi-Organ Failure	General disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Abdominal Wall Abscess	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Brain Abscess	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Pneumonia	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0005 events5 affected53 at risk EG0015 events4 affected77 at risk EG0021 events1 affected19 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0021 events1 affected19 at risk EG003
Sepsis	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0002 events2 affected53 at risk EG0013 events3 affected77 at risk EG0020 events0 affected19 at risk EG003
Septic Shock	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0006 events6 affected53 at risk EG0014 events4 affected77 at risk EG0021 events1 affected19 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Wound Infection Fungal	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Endotracheal Intubation Complication	Injury, poisoning and procedural complications	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Head Injury	Injury, poisoning and procedural complications	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Operative Haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Procedural Hypotension	Injury, poisoning and procedural complications	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Tracheostomy Malfunction	Injury, poisoning and procedural complications	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Traumatic Brain Injury	Injury, poisoning and procedural complications	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Blood Creatinine Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Oxygen Saturation Decreased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0012 events2 affected77 at risk EG0020 events0 affected19 at risk EG003
Convulsion	Nervous system disorders	MedDRA Version 14.0	Systematic Assessment	EG0002 events2 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Headache	Nervous system disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Post-Traumatic Amnestic Disorder	Psychiatric disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Anuria	Renal and urinary disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0012 events2 affected77 at risk EG0020 events0 affected19 at risk EG003
Renal Failure	Renal and urinary disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Renal Failure Acute	Renal and urinary disorders	MedDRA Version 14.0	Systematic Assessment	EG0002 events2 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Dependence On Respirator	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Laryngeal Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0002 events2 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0002 events2 affected53 at risk EG0012 events2 affected77 at risk EG0020 events0 affected19 at risk EG003
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Subcutaneous Emphysema	Skin and subcutaneous tissue disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Haemodynamic Instability	Vascular disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Haemorrhage	Vascular disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 14.0	Systematic Assessment	EG0004 events3 affected53 at risk EG0015 events4 affected77 at risk EG0021 events1 affected19 at risk EG0033 events3 affected67 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0021 events1 affected19 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0014 events4 affected77 at risk EG0020 events0 affected19 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0012 events2 affected77 at risk EG0021 events1 affected19 at risk EG003
Bradycardia	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Left Ventricular Failure	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0021 events1 affected19 at risk EG003
Myocardial Ischaemia	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Sinus Tachycardia	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Tachycardia	Cardiac disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0012 events2 affected77 at risk EG0021 events1 affected19 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0021 events1 affected19 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0012 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Parotid Gland Enlargement	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 14.0	Systematic Assessment	EG0003 events3 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Acinetobacter Infection	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0012 events2 affected77 at risk EG0020 events0 affected19 at risk EG003
Candiduria	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0021 events1 affected19 at risk EG003
Cellulitis	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Herpes Dermatitis	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Liver Abscess	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0021 events1 affected19 at risk EG003
Nosocomial Infection	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0014 events3 affected77 at risk EG0020 events0 affected19 at risk EG003
Peritoneal Tuberculosis	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Pneumonia	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0002 events1 affected53 at risk EG0015 events4 affected77 at risk EG0022 events2 affected19 at risk EG003
Postoperative Wound Infection	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Sepsis	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Soft Tissue Infection	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Staphylococcal Bacteraemia	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0013 events3 affected77 at risk EG0021 events1 affected19 at risk EG003
Staphylococcal Infection	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Staphylococcal Sepsis	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0021 events1 affected19 at risk EG003
Stenotrophomonas Sepsis	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0002 events2 affected53 at risk EG0012 events2 affected77 at risk EG0021 events1 affected19 at risk EG003
Wound Infection	Infections and infestations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0004 events4 affected53 at risk EG0013 events3 affected77 at risk EG0020 events0 affected19 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0003 events3 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Bilirubin Conjugated Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Blood Alkaline Phosphatase Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0005 events5 affected53 at risk EG0012 events2 affected77 at risk EG0021 events1 affected19 at risk EG003
Blood Bicarbonate Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Blood Bilirubin Unconjugated Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Blood Cortisol Decreased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Blood Creatine Phosphokinase Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Blood Lactate Dehydrogenase Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0012 events2 affected77 at risk EG0020 events0 affected19 at risk EG003
Blood Triglycerides Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Coagulation Time Prolonged	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Creatinine Renal Clearance Decreased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Gamma-Glutamyltransferase Abnormal	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Gamma-Glutamyltransferase Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0005 events5 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Glomerular Filtration Rate Decreased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Haematocrit Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Haemoglobin Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Hepatic Enzyme Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Liver Function Test Abnormal	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Oxygen Saturation Decreased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Red Blood Cell Count Decreased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Transaminases Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
White Blood Cell Count Decreased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
White Blood Cell Count Increased	Investigations	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Fluid Overload	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0021 events1 affected19 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0012 events2 affected77 at risk EG0021 events1 affected19 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0003 events3 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Hypochloraemia	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0022 events1 affected19 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0005 events4 affected53 at risk EG0012 events2 affected77 at risk EG0021 events1 affected19 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected77 at risk EG0021 events1 affected19 at risk EG003
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Metabolic Alkalosis	Metabolism and nutrition disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 14.0	Systematic Assessment	EG0004 events4 affected53 at risk EG0015 events5 affected77 at risk EG0020 events0 affected19 at risk EG003
Pruritus Generalised	Skin and subcutaneous tissue disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Subcutaneous Emphysema	Skin and subcutaneous tissue disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Hypertension	Vascular disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Hypotension	Vascular disorders	MedDRA Version 14.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected77 at risk EG0020 events0 affected19 at risk EG003
Phlebitis	Vascular disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA Version 14.0	Systematic Assessment	EG0004 events3 affected53 at risk EG0011 events1 affected77 at risk EG0026 events4 affected19 at risk EG003
Withdrawal Hypertension	Vascular disorders	MedDRA Version 14.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected77 at risk EG0020 events0 affected19 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Hong Kong			Hong Kong

ID	Term
D011014	Pneumonia
D053717	Pneumonia, Ventilator-Associated
D014552	Urinary Tract Infections
D000077299	Healthcare-Associated Pneumonia
D059413	Intraabdominal Infections

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D003428	Cross Infection
D007049	Iatrogenic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Term
D015780	Carbapenems
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930	Organic Chemicals
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nosocomial Pneumonia (NP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days	22	53	27	53
EG001	Ventilator-Associated Pneumonia (VAP)	500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days	24	77	38	77
EG002	Complicated Urinary Tract Infection (cUTI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days	3	19	11	19
EG003	Complicated Intra-abdominal Infection (cIAI)	500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days	15	67	32	67