Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration -

Completed

Brief Summary: The purpose of the survey is to study the followings under practical use, regarding the safety and effectiveness in high-dose administration (exceeding 6 g per day) of UNASYN-S and UNASYN-S KIT for intravenous use (UNASYN).

1. Adverse Drug Reaction(s) that cannot be expected from precautions (Unexpected Adverse Drug Reaction)

2. Incidence status of adverse drug reactions

3. Factors that may affect the safety and effectiveness

Detailed Description: Implemented as a Special Investigation by a central registration system. Secondary data collection. Safety and effectiveness of UNASYN-S under Japanese medical practice.

Recruitment & Eligibility

Inclusion Criteria

Patients with the following disease who received high doses of UNASYN (exceeding 6 g per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis
Patients aged 15 years or more

Exclusion Criteria

Patients with the following disease who received high doses of UNASYN (less than 6 g per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis
Patients aged less than 15 years.

Arm && Interventions

Group	Intervention	Description
Sulbactam Sodium/Ampicillin Sodium	Sulbactam Sodium/Ampicillin Sodium	Patients with the following disease who received high doses of UNASYN (exceeding 6 g per day) by intravenous injection or intravenous drip infusion from the first dosing date or the second dosing date: Pneumonia, Lung Abscess, Peritonitis.

Primary Outcome Measures

Name	Time	Method
Clinical Effectiveness Rate by Indication	14 Days	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of participants with assessable effectiveness evaluation, was presented by each indication (pneumonia, lung abcess and peritorinitis) along with the corresponding exact 2-sided 95% confidence interval. Overall effectiveness of sulbactam sodium/ampicillin sodium was determined by the investigator based on clinical symptoms and examinations at the end of high-dose (\>6 g daily) treatment. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at the end of treatment.
Number of Participants With Treatment-Related Adverse Events	14 Days	A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert	14 Days	A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.
Number of Participants With Treatment-Related Serious Adverse Events	14 Days	A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.