Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00810407
• Collaborator: (none)
• Enrollment: 628
• Actual Duration (Months): 92

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
Tuberculosis; Non-tuberculous Mycobacterial Diseases (Including MAC Disease)	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: 628 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Special Investigation For Non-hiv Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).
• Actual Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

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".; Other Names: Mycobutin.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Related Adverse Events [1 year]

   A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator.

2. Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [1 year]

   A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Mycobutin was assessed by the physician/investigator.

3. Number of Participants With Treatment-Related Adverse Events by Diagnosis [1 year]

   A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by diagnosis to assess whether they were risk factors for the treatment related adverse events.

4. Number of Participants With Treatment-Related Adverse Events by Gender [1 year]

   A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether they were risk factors for the treatment related adverse events.

5. Number of Participants With Treatment-Related Adverse Events by Age [1 year]

   A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether they were risk factors for the treatment related adverse events.

6. Clinical Efficacy Rate [1 year]

   Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values.

7. Clinical Efficacy Rate by Diagnosis [1 year]

   Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by diagnosis were counted to assess whether they contribute to the clinical effectiveness.

8. Clinical Efficacy Rate by Gender [1 year]

   Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by gender were counted to assess whether they contribute to the clinical effectiveness.

9. Clinical Efficacy Rate by Age [1 year]

   Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by age were counted to assess whether they contribute to the clinical effectiveness.

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)

None provided.

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: NCT00810407
• Other Study ID Numbers: A0061006
• First Posted: Dec 18, 2008
• Last Update Posted: Mar 7, 2019
• Last Verified: Nov 1, 2018

• Additional relevant MeSH terms: Tuberculosis; Mycobacterium Infections; Rifabutin

Study Results

Participant Flow

Pre-assignment Detail	A total 628 subjects were registered in this study. Of the 628 subjects, 594 subjects CRFs were collected and included in the study. Of the 594 subjects, 6 subjects were excluded from the safety analysis set (SAS). In total, 588 subjects were included in the SAS as the completed the study

Arm/Group Title	Mycobutin (Rifabutin)
Arm/Group Description	Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
Period Title: Overall Study
STARTED	594
COMPLETED	588
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Mycobutin (Rifabutin)
Arm/Group Description	Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
Overall Participants	588
Age, Customized (Count of Participants)
<15 years	1 0.2%
≥15 and <65 years	234 39.8%
≥65 years	349 59.4%
Unknown	4 0.7%
Sex: Female, Male (Count of Participants)
Female	363 61.7%
Male	225 38.3%
Diagnosis (Count of Participants)
Tuberculosis	134 22.8%
Mycobacterium Avium Complex (MAC)	428 72.8%
Non-tuberculous Mycobacteria Other Than MAC	19 3.2%
Coinfection	5 0.9%
Others	2 0.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Mycobutin (Rifabutin)
Arm/Group Description	Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
Measure Participants	588
Treatment-Related Adverse Event	387 65.8%
Treatment-Related Serious Adverse Event	113 19.2%

2. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Mycobutin was assessed by the physician/investigator.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Mycobutin (Rifabutin)
Arm/Group Description	Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
Measure Participants	588
Count of Participants [Participants]	71 12.1%

3. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events by Diagnosis
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by diagnosis to assess whether they were risk factors for the treatment related adverse events.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Mycobutin (Rifabutin)
Arm/Group Description	Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
Measure Participants	588
Tuberculosis	60 10.2%
Mycobacterium Avium Complex (MAC)	312 53.1%
Non-tuberculous Mycobacteria Other Than MAC	11 1.9%
Coinfection	4 0.7%
Others	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mycobutin (Rifabutin)
	Comments	The factor tested was "diagnosis". The null hypothesis was that there was no association between diagnosis and the number of participants with treatment-related adverse events.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

4. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events by Gender
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether they were risk factors for the treatment related adverse events.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Mycobutin (Rifabutin)
Arm/Group Description	Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
Measure Participants	588
Female	264 44.9%
Male	123 20.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mycobutin (Rifabutin)
	Comments	The factor tested was "gender". The null hypothesis was that there was no association between gender and the number of participants with treatment-related adverse events.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

5. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events by Age
Description	A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether they were risk factors for the treatment related adverse events.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Mycobutin (Rifabutin)
Arm/Group Description	Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
Measure Participants	588
<15 years	1 0.2%
≥15 and <65 years	149 25.3%
≥65 years	235 40%
Unknown	2 0.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mycobutin (Rifabutin)
	Comments	The factor tested was "age". The null hypothesis was that there was no association between age of participants and the number of participants with treatment-related adverse events.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.587
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Mycobutin (Rifabutin)
	Comments	The factor tested was "age". The null hypothesis was that there was no ordinal trend in the number of participants with treatment-related adverse events across the age at baseline.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.428
	Comments
	Method	Cochran-Armitage (EXACT)
	Comments

6. Primary Outcome

Title	Clinical Efficacy Rate
Description	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values.
Time Frame	1 year

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/investigator based upon change in clinical symptoms and laboratory findings) at least once.

Arm/Group Title	Mycobutin (Rifabutin)
Arm/Group Description	Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
Measure Participants	332
Number (95% Confidence Interval) [Percentage of Participants]	62.7 10.7%

7. Primary Outcome

Title	Clinical Efficacy Rate by Diagnosis
Description	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by diagnosis were counted to assess whether they contribute to the clinical effectiveness.
Time Frame	1 year

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/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.

Arm/Group Title	Mycobutin (Rifabutin)
Arm/Group Description	Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
Measure Participants	332
Tuberculosis	82.3 14%
Mycobacterium Avium Complex (MAC)	53.9 9.2%
Non-tuberculous Mycobacteria Other Than MAC	58.3 9.9%
Coinfection	100.0 17%
Others	0.0 0%

8. Primary Outcome

Title	Clinical Efficacy Rate by Gender
Description	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by gender were counted to assess whether they contribute to the clinical effectiveness.
Time Frame	1 year

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/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.

Arm/Group Title	Mycobutin (Rifabutin)
Arm/Group Description	Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
Measure Participants	332
Male	71.1 12.1%
Female	55.7 9.5%

9. Primary Outcome

Title	Clinical Efficacy Rate by Age
Description	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by age were counted to assess whether they contribute to the clinical effectiveness.
Time Frame	1 year

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/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.

Arm/Group Title	Mycobutin (Rifabutin)
Arm/Group Description	Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
Measure Participants	332
˂15 years	0.0 0%
≥15 and <65 years	71.8 12.2%
≥65 years	57.1 9.7%
Unknown	50 8.5%

Adverse Events

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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Mycobutin (Rifabutin)
Arm/Group Description	Participants who received Mycobutin as indicated in the approved local product document were observed for a period of 1 year. The dosage can be adjusted as per physician's discretion.
All Cause Mortality
	Mycobutin (Rifabutin)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Mycobutin (Rifabutin)
	Affected / at Risk (%)	# Events
Total	184/588 (31.3%)
Blood and lymphatic system disorders
Anaemia	5/588 (0.9%)
Bone marrow failure	2/588 (0.3%)
Disseminated intravascular coagulation	1/588 (0.2%)
Granulocytopenia	1/588 (0.2%)
Leukopenia	5/588 (0.9%)
Neutropenia	1/588 (0.2%)
Pancytopenia	2/588 (0.3%)
Thrombocytopenia	6/588 (1%)
Cardiac disorders
Acute myocardial infarction	1/588 (0.2%)
Angina unstable	1/588 (0.2%)
Cardiac failure	4/588 (0.7%)
Cardiac failure acute	2/588 (0.3%)
Cardiogenic shock	1/588 (0.2%)
Cardio-respiratory arrest	1/588 (0.2%)
Cor pulmonale	2/588 (0.3%)
Myocardial infarction	1/588 (0.2%)
Right ventricular failure	1/588 (0.2%)
Eye disorders
Optic neuropathy	1/588 (0.2%)
Uveitis	12/588 (2%)
Visual acuity reduced	2/588 (0.3%)
Gastrointestinal disorders
Nausea	2/588 (0.3%)
Gastritis	1/588 (0.2%)
Diarrhoea	5/588 (0.9%)
Stomatitis	1/588 (0.2%)
Abdominal pain upper	1/588 (0.2%)
Gastrointestinal amyloidosis	1/588 (0.2%)
Gastrointestinal disorder	1/588 (0.2%)
Gastrointestinal haemorrhage	1/588 (0.2%)
Intestinal obstruction	1/588 (0.2%)
Pancreatitis	1/588 (0.2%)
General disorders
Chills	1/588 (0.2%)
Malaise	1/588 (0.2%)
Pyrexia	18/588 (3.1%)
Oedema peripheral	1/588 (0.2%)
Death	2/588 (0.3%)
Drug interaction	1/588 (0.2%)
Multiple organ dysfunction syndrome	2/588 (0.3%)
Hepatobiliary disorders
Jaundice	1/588 (0.2%)
Hepatic function abnormal	10/588 (1.7%)
Liver disorder	20/588 (3.4%)
Hyperbilirubinaemia	1/588 (0.2%)
Drug-induced liver injury	1/588 (0.2%)
Cholecystitis	1/588 (0.2%)
Cholestasis	1/588 (0.2%)
Immune system disorders
Drug hypersensitivity	1/588 (0.2%)
Hypersensitivity	1/588 (0.2%)
Infections and infestations
Gastroenteritis	1/588 (0.2%)
Pneumonia	12/588 (2%)
Aspergillus infection	1/588 (0.2%)
Atypical mycobacterial infection	2/588 (0.3%)
Bronchopulmonary aspergillosis	2/588 (0.3%)
Cystitis	1/588 (0.2%)
Diabetic gangrene	1/588 (0.2%)
Infectious pleural effusion	1/588 (0.2%)
Mycobacterium avium complex infection	4/588 (0.7%)
Osteomyelitis	1/588 (0.2%)
Pneumonia bacterial	3/588 (0.5%)
Pneumonia pseudomonal	1/588 (0.2%)
Pulmonary mycosis	1/588 (0.2%)
Pulmonary tuberculosis	1/588 (0.2%)
Pulpitis dental	1/588 (0.2%)
Sepsis	1/588 (0.2%)
Septic shock	1/588 (0.2%)
Tuberculosis	1/588 (0.2%)
Injury, poisoning and procedural complications
Femoral neck fracture	1/588 (0.2%)
Subdural haematoma	2/588 (0.3%)
Traumatic intracranial haemorrhage	1/588 (0.2%)
Investigations
Platelet count decreased	10/588 (1.7%)
Neutrophil count decreased	2/588 (0.3%)
White blood cell count decreased	11/588 (1.9%)
Alanine aminotransferase increased	1/588 (0.2%)
Aspartate aminotransferase increased	1/588 (0.2%)
Blood pressure decreased	1/588 (0.2%)
Electrocardiogram QT prolonged	1/588 (0.2%)
Hepatic enzyme increased	1/588 (0.2%)
International normalised ratio increased	1/588 (0.2%)
Liver function test abnormal	1/588 (0.2%)
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	1/588 (0.2%)
Decreased appetite	12/588 (2%)
Hypokalaemia	1/588 (0.2%)
Hypoglycaemia	1/588 (0.2%)
Hyponatraemia	1/588 (0.2%)
Malnutrition	1/588 (0.2%)
Marasmus	1/588 (0.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/588 (0.3%)
Myalgia	2/588 (0.3%)
Lumbar spinal stenosis	1/588 (0.2%)
Rhabdomyolysis	3/588 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm	1/588 (0.2%)
Colon cancer	1/588 (0.2%)
Waldenstrom's macroglobulinaemia	1/588 (0.2%)
Nervous system disorders
Optic neuritis	1/588 (0.2%)
Dysgeusia	1/588 (0.2%)
Altered state of consciousness	1/588 (0.2%)
Cerebral infarction	1/588 (0.2%)
Loss of consciousness	2/588 (0.3%)
Syncope	1/588 (0.2%)
Tonic convulsion	1/588 (0.2%)
Tremor	1/588 (0.2%)
Pregnancy, puerperium and perinatal conditions
Abortion	1/588 (0.2%)
Renal and urinary disorders
Renal impairment	2/588 (0.3%)
Respiratory, thoracic and mediastinal disorders
Pneumothorax	5/588 (0.9%)
Haemoptysis	6/588 (1%)
Asthma	1/588 (0.2%)
Allergic bronchitis	1/588 (0.2%)
Asphyxia	1/588 (0.2%)
Chronic respiratory failure	1/588 (0.2%)
Hypercapnia	1/588 (0.2%)
Idiopathic pulmonary fibrosis	1/588 (0.2%)
Interstitial lung disease	3/588 (0.5%)
Pneumonia aspiration	3/588 (0.5%)
Respiratory failure	9/588 (1.5%)
Respiratory tract haemorrhage	1/588 (0.2%)
Sputum retention	1/588 (0.2%)
Skin and subcutaneous tissue disorders
Rash generalised	1/588 (0.2%)
Toxic skin eruption	1/588 (0.2%)
Rash	3/588 (0.5%)
Drug eruption	8/588 (1.4%)
Decubitus ulcer	1/588 (0.2%)
Vascular disorders
Hypertension	1/588 (0.2%)
Circulatory collapse	1/588 (0.2%)
Hypotension	1/588 (0.2%)
Other (Not Including Serious) Adverse Events
	Mycobutin (Rifabutin)
	Affected / at Risk (%)	# Events
Total	470/588 (79.9%)
Blood and lymphatic system disorders
Anaemia	19/588 (3.2%)
Leukopenia	18/588 (3.1%)
Gastrointestinal disorders
Diarrhoea	23/588 (3.9%)
Nausea	18/588 (3.1%)
General disorders
Pyrexia	62/588 (10.5%)
Hepatobiliary disorders
Liver disorder	29/588 (4.9%)
Hepatic function abnormal	66/588 (11.2%)
Investigations
Gamma-glutamyltransferase increased	19/588 (3.2%)
Platelet count decreased	54/588 (9.2%)
White blood cell count decreased	62/588 (10.5%)
Metabolism and nutrition disorders
Decreased appetite	52/588 (8.8%)
Skin and subcutaneous tissue disorders
Drug eruption	21/588 (3.6%)
Rash	27/588 (4.6%)

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.