N/A
N=72
Safety And Efficacy Of Rifabutin In HIV Patients
Non-tuberculous Mycobacterial Diseases · Tuberculosis · Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00810446 ↗Enrolled (actual)
72
Serious AEs
20.8%
Results posted
Aug 2019
Primary outcome: Primary: Number of Patients With Adverse Drug Reactions in This Surveillance — 16; 7 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- rifabutin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Drug Reactions in This Surveillance |
16; 7 | — |
| PRIMARY The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions) |
7 | — |
| PRIMARY Number of Participants With Adverse Drug Reactions by Gender |
16; 0 | — |
| PRIMARY Number of Participants With Adverse Drug Reactions by Age |
16; 0 | — |
| PRIMARY Number of Participants With Adverse Drug Reactions by Diagnosis |
7; 8; 0; 1; 0 | — |
| PRIMARY Clinical Response Rate (Therapeutic) |
80.6 | — |
| PRIMARY Clinical Response Rate (Therapeutic) by Gender |
80.0; 100.0 | — |
| PRIMARY Clinical Response Rate (Therapeutic) by Age |
80.0; 100.0 | — |
| PRIMARY Clinical Response Rate (Therapeutic) by Diagnosis |
78.3; 89.7; 57.1; 50.0; 100.0 | — |
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 (NCT00810446). 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.