N/A Completed N=982

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

Pneumonia · Lung Abscess · Peritonitis

Source: ClinicalTrials.gov NCT01793688 ↗

Enrolled (actual)

982

Serious AEs

4.4%

Results posted

Apr 2017

Primary outcomePrimary: Number of Participants With Treatment-Related Adverse Events — 96 Participants

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Related Adverse Events	96	—
PRIMARY Clinical Effectiveness Rate by Indication	85.1; 78.5; 78.7	—
SECONDARY Number of Participants With Treatment-Related Serious Adverse Events	6	—
SECONDARY Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert	30	—

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT01793688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.