N/A
N=594
Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
Tuberculosis · Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
Bottom Line
View on ClinicalTrials.gov: NCT00810407 ↗Enrolled (actual)
594
Serious AEs
31.3%
Results posted
Mar 2019
Primary outcome: Primary: Number of Participants With Treatment-Related Adverse Events — 387; 113 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- rifabutin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Related Adverse Events |
387; 113 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert |
71 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events by Diagnosis |
60; 312; 11; 4; 0 | <0.001 sig |
| PRIMARY Number of Participants With Treatment-Related Adverse Events by Gender |
264; 123 | <0.001 sig |
| PRIMARY Number of Participants With Treatment-Related Adverse Events by Age |
1; 149; 235; 2 | 0.587 |
| PRIMARY Clinical Efficacy Rate |
62.7 | — |
| PRIMARY Clinical Efficacy Rate by Diagnosis |
82.3; 53.9; 58.3; 100.0; 0.0 | — |
| PRIMARY Clinical Efficacy Rate by Gender |
71.1; 55.7 | — |
| PRIMARY Clinical Efficacy Rate by Age |
0.0; 71.8; 57.1; 50 | — |
Summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Eligibility Criteria
Inclusion Criteria
- Patients need to be administered Mycobutin® in order to be enrolled in the surveillance.
Exclusion Criteria
- Patients not administered Mycobutin®.
Data sourced from ClinicalTrials.gov (NCT00810407). 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.