Safety And Efficacy Of Rifabutin In HIV Patients

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00810446
• Collaborator: (none)
• Enrollment: 72
• Actual Duration (Months): 105

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-tuberculous Mycobacterial Diseases; Tuberculosis; Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections	Drug: rifabutin

Detailed Description

All the patients whom an investigator prescribes the first Mycobutin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Study Design

• Study Type: Observational
• Actual Enrollment: 72 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: DRUG USE INVESTIGATION FOR HIV INFECTION PATIENTS OF MYCOBUTIN (REGULATORY POST MARKETING COMMITMENT PLAN).
• Actual Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm

Intervention/Treatment

rifabutin Patients administered Rifabutin.

Drug: rifabutin; Mycobutin® capsules150mg depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " 1.Tuberculosis : The usual adult dosage for oral use is 150 mg to 300 mg of rifabutin once daily.For the treatment of multiple-drug resistance tuberculosis, the usual dosage for oral use is 300 to 450 mg of rifabutin once daily. 2.Treatment of non-tuberculous mycobacterial diseases (including MAC disease) : The usual adult dosage for oral use is 300 mg of rifabutin once daily. 3.Inhibition of disseminated Mycobacterium avium complex (MAC) disease associated with HIV infections : The usual adult dosage for oral use is 300 mg of rifabutin once daily.".; Other Names: Mycobutin

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Adverse Drug Reactions in This Surveillance [6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)]

   An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to MYCOBUTIN Capsules was assessed by the physician.

2. The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions) [6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)]

   An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Expectedness of the adverse drug reaction was determined according to the Japanese package insert.

3. Number of Participants With Adverse Drug Reactions by Gender [6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)]

   An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Participants with ADRs were counted by gender to access whether it was a risk factor for the ADR.

4. Number of Participants With Adverse Drug Reactions by Age [6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)]

   An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Participants with ADRs were counted by age to assess whether it was a risk factor for the ADR.

5. Number of Participants With Adverse Drug Reactions by Diagnosis [6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)]

   An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Participants with ADRs were counted by diagnosis to assess whether it was a risk factor for the ADR.

6. Clinical Response Rate (Therapeutic) [6.5 years (at maximum)]

   Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response.

7. Clinical Response Rate (Therapeutic) by Gender [6.5 years (at maximum)]

   Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response. Participants who achieved clinical response by gender were counted to assess whether it contributed to clinical response.

8. Clinical Response Rate (Therapeutic) by Age [6.5 years (at maximum)]

   Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response. Participants who achieved clinical response by age were counted to assess whether it contributed to clinical response.

9. Clinical Response Rate (Therapeutic) by Diagnosis [6.5 years (at maximum)]

   Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response. Participants who achieved clinical response by diagnosis were counted to assess whether it contributed to clinical response.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients need to be administered Mycobutin® in order to be enrolled in the surveillance.

Exclusion Criteria:

• Patients not administered Mycobutin®.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Statistical Analysis Plan - Jun 24, 2016
• Study Protocol - Nov 1, 2015

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00810446
• Other Study ID Numbers: A0061007
• First Posted: Dec 18, 2008
• Last Update Posted: Aug 2, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome; Tuberculosis; Mycobacterium Infections; Mycobacterium avium-intracellulare Infection; Rifabutin

Study Results

Participant Flow

Arm/Group Title	MYCOBUTIN Capsules (Rifabutin)
Arm/Group Description	Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
Period Title: Overall Study
STARTED	72
COMPLETED	72
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	MYCOBUTIN Capsules (Rifabutin)
Arm/Group Description	Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
Overall Participants	72
Age, Customized (Number) [Number]
<15 years	0 0%
≥15 and <65 years	69 95.8%
≥65 years	3 4.2%
Sex/Gender, Customized (Number) [Number]
Male	69 95.8%
Female	3 4.2%
Race/Ethnicity, Customized (Number) [Number]
Japanese	64 88.9%
Others	8 11.1%
Diagnosis (Number) [Number]
MAC (Therapeutic)	31 43.1%
MAC (Preventive)	0 0%
Tuberculosis	30 41.7%
NTM Infection Other Than MAC	8 11.1%
MAC (Therapeutic) and NTM Infection Other Than MAC	2 2.8%
Others	1 1.4%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Adverse Drug Reactions in This Surveillance
Description	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to MYCOBUTIN Capsules was assessed by the physician.
Time Frame	6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.

Arm/Group Title	MYCOBUTIN Capsules (Rifabutin)
Arm/Group Description	Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
Measure Participants	72
ADR	16 22.2%
Serious ADR	7 9.7%

2. Primary Outcome

Title	The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions)
Description	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Expectedness of the adverse drug reaction was determined according to the Japanese package insert.
Time Frame	6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.

Arm/Group Title	MYCOBUTIN Capsules (Rifabutin)
Arm/Group Description	Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
Measure Participants	72
Number [Participants]	7 9.7%

3. Primary Outcome

Title	Number of Participants With Adverse Drug Reactions by Gender
Description	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Participants with ADRs were counted by gender to access whether it was a risk factor for the ADR.
Time Frame	6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.

Arm/Group Title	MYCOBUTIN Capsules (Rifabutin)
Arm/Group Description	Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
Measure Participants	72
Male	16 22.2%
Female	0 0%

4. Primary Outcome

Title	Number of Participants With Adverse Drug Reactions by Age
Description	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Participants with ADRs were counted by age to assess whether it was a risk factor for the ADR.
Time Frame	6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.

Arm/Group Title	MYCOBUTIN Capsules (Rifabutin)
Arm/Group Description	Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
Measure Participants	72
≥15 and <65 years	16 22.2%
≥65 years	0 0%

5. Primary Outcome

Title	Number of Participants With Adverse Drug Reactions by Diagnosis
Description	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Participants with ADRs were counted by diagnosis to assess whether it was a risk factor for the ADR.
Time Frame	6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.

Arm/Group Title	MYCOBUTIN Capsules (Rifabutin)
Arm/Group Description	Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
Measure Participants	72
MAC (Therapeutic)	7 9.7%
Tuberculosis	8 11.1%
NTM Infections Other Than MAC	0 0%
MAC (Therapeutic) and NTM Infection Other Than MAC	1 1.4%
Others	0 0%

6. Primary Outcome

Title	Clinical Response Rate (Therapeutic)
Description	Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response.
Time Frame	6.5 years (at maximum)

Outcome Measure Data

Analysis Population Description

The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at the final observation point. Participants assessed as "indeterminable (n=10)" at the final observation were excluded.

Arm/Group Title	MYCOBUTIN Capsules (Rifabutin)
Arm/Group Description	Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
Measure Participants	72
Number (95% Confidence Interval) [Percentage of Participants]	80.6 111.9%

7. Primary Outcome

Title	Clinical Response Rate (Therapeutic) by Gender
Description	Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response. Participants who achieved clinical response by gender were counted to assess whether it contributed to clinical response.
Time Frame	6.5 years (at maximum)

Outcome Measure Data

Analysis Population Description

The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at the final observation point. Participants assessed as "indeterminable (n=10)" at the final observation were excluded.

Arm/Group Title	MYCOBUTIN Capsules (Rifabutin)
Arm/Group Description	Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
Measure Participants	72
Male	80.0 111.1%
Female	100.0 138.9%

8. Primary Outcome

Title	Clinical Response Rate (Therapeutic) by Age
Description	Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response. Participants who achieved clinical response by age were counted to assess whether it contributed to clinical response.
Time Frame	6.5 years (at maximum)

Outcome Measure Data

Analysis Population Description

The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at the final observation point. Participants assessed as "indeterminable (n=10)" at the final observation were excluded.

Arm/Group Title	MYCOBUTIN Capsules (Rifabutin)
Arm/Group Description	Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
Measure Participants	72
≥15 and <65 years	80.0 111.1%
≥65 years	100.0 138.9%

9. Primary Outcome

Title	Clinical Response Rate (Therapeutic) by Diagnosis
Description	Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response. Participants who achieved clinical response by diagnosis were counted to assess whether it contributed to clinical response.
Time Frame	6.5 years (at maximum)

Outcome Measure Data

Analysis Population Description

The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at the final observation point. Participants assessed as "indeterminable (n=10)" at the final observation were excluded.

Arm/Group Title	MYCOBUTIN Capsules (Rifabutin)
Arm/Group Description	Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
Measure Participants	72
MAC (Therapeutic)	78.3 108.8%
Tuberculosis	89.7 124.6%
NTM Infections Other Than MAC	57.1 79.3%
MAC (Therapeutic) and NTM Infection Other Than MAC	50.0 69.4%
Others	100.0 138.9%

Adverse Events

Time Frame	6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
Adverse Event Reporting Description	The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Arm/Group Title	MYCOBUTIN Capsules (Rifabutin)
Arm/Group Description	Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician's discretion.
All Cause Mortality
	MYCOBUTIN Capsules (Rifabutin)
	Affected / at Risk (%)	# Events
Total	2/72 (2.8%)
Serious Adverse Events
	MYCOBUTIN Capsules (Rifabutin)
	Affected / at Risk (%)	# Events
Total	15/72 (20.8%)
Blood and lymphatic system disorders
Pancytopenia	2/72 (2.8%)
Eye disorders
Necrotising retinitis	1/72 (1.4%)
Gastrointestinal disorders
Nausea	2/72 (2.8%)
Vomiting	1/72 (1.4%)
General disorders
Drug resistance	1/72 (1.4%)
Immune system disorders
Immune reconstitution inflammatory syndrome	4/72 (5.6%)
Infections and infestations
Cytomegalovirus chorioretinitis	3/72 (4.2%)
Mycobacterium avium complex infection	1/72 (1.4%)
Arthritis bacterial	1/72 (1.4%)
Herpes zoster	1/72 (1.4%)
Cerebral toxoplasmosis	1/72 (1.4%)
Lung infection	1/72 (1.4%)
Subcutaneous abscess	1/72 (1.4%)
Atypical mycobacterial infection	1/72 (1.4%)
Injury, poisoning and procedural complications
Lumbar vertebral fracture	1/72 (1.4%)
Spinal compression fracture	1/72 (1.4%)
Investigations
Platelet count decreased	1/72 (1.4%)
White blood cell count decreased	1/72 (1.4%)
Musculoskeletal and connective tissue disorders
Osteoporosis	1/72 (1.4%)
Psychiatric disorders
Irritability	1/72 (1.4%)
Hallucination, auditory	1/72 (1.4%)
Bipolar disorder	1/72 (1.4%)
Anxiety	1/72 (1.4%)
Depressive symptom	1/72 (1.4%)
Renal and urinary disorders
Renal disorder	1/72 (1.4%)
Skin and subcutaneous tissue disorders
Erythema multiforme	1/72 (1.4%)
Other (Not Including Serious) Adverse Events
	MYCOBUTIN Capsules (Rifabutin)
	Affected / at Risk (%)	# Events
Total	28/72 (38.9%)
Gastrointestinal disorders
Nausea	2/72 (2.8%)
Hepatobiliary disorders
Hepatic function abnormal	3/72 (4.2%)
Immune system disorders
Immune reconstitution inflammatory syndrome	5/72 (6.9%)
Infections and infestations
Herpes zoster	4/72 (5.6%)
Investigations
Blood triglycerides increased	4/72 (5.6%)
Metabolism and nutrition disorders
Hypertriglyceridaemia	2/72 (2.8%)
Hyperlipidaemia	2/72 (2.8%)
Renal and urinary disorders
Renal impairment	4/72 (5.6%)
Skin and subcutaneous tissue disorders
Rash	2/72 (2.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.