N/A
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
Bottom Line
View on ClinicalTrials.gov: NCT01793688 ↗Enrolled (actual)
982
Serious AEs
4.4%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants With Treatment-Related Adverse Events — 96 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Sulbactam Sodium/Ampicillin Sodium (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2016
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 | — |
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
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.
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.