Trial Outcomes & Findings for Safety And Efficacy Of Rifabutin In HIV Patients (NCT NCT00810446)
NCT ID: NCT00810446
Last Updated: 2019-08-02
Results Overview
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.
COMPLETED
72 participants
6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
2019-08-02
Participant Flow
Participant milestones
| Measure |
MYCOBUTIN Capsules (Rifabutin)
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.
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|---|---|
|
Overall Study
STARTED
|
72
|
|
Overall Study
COMPLETED
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72
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety And Efficacy Of Rifabutin In HIV Patients
Baseline characteristics by cohort
| Measure |
MYCOBUTIN Capsules (Rifabutin)
n=72 Participants
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.
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|---|---|
|
Age, Customized
<15 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
≥15 and <65 years
|
69 Participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
3 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
69 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
3 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Japanese
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64 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Others
|
8 Participants
n=5 Participants
|
|
Diagnosis
MAC (Therapeutic)
|
31 Participants
n=5 Participants
|
|
Diagnosis
MAC (Preventive)
|
0 Participants
n=5 Participants
|
|
Diagnosis
Tuberculosis
|
30 Participants
n=5 Participants
|
|
Diagnosis
NTM Infection Other Than MAC
|
8 Participants
n=5 Participants
|
|
Diagnosis
MAC (Therapeutic) and NTM Infection Other Than MAC
|
2 Participants
n=5 Participants
|
|
Diagnosis
Others
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
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.
Outcome measures
| Measure |
MYCOBUTIN Capsules (Rifabutin)
n=72 Participants
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.
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|---|---|
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Number of Patients With Adverse Drug Reactions in This Surveillance
ADR
|
16 Participants
|
|
Number of Patients With Adverse Drug Reactions in This Surveillance
Serious ADR
|
7 Participants
|
PRIMARY outcome
Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
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.
Outcome measures
| Measure |
MYCOBUTIN Capsules (Rifabutin)
n=72 Participants
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.
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|---|---|
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The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions)
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7 Participants
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PRIMARY outcome
Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
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.
Outcome measures
| Measure |
MYCOBUTIN Capsules (Rifabutin)
n=72 Participants
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.
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|---|---|
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Number of Participants With Adverse Drug Reactions by Gender
Male
|
16 Participants
|
|
Number of Participants With Adverse Drug Reactions by Gender
Female
|
0 Participants
|
PRIMARY outcome
Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
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.
Outcome measures
| Measure |
MYCOBUTIN Capsules (Rifabutin)
n=72 Participants
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.
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|---|---|
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Number of Participants With Adverse Drug Reactions by Age
≥15 and <65 years
|
16 Participants
|
|
Number of Participants With Adverse Drug Reactions by Age
≥65 years
|
0 Participants
|
PRIMARY outcome
Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
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.
Outcome measures
| Measure |
MYCOBUTIN Capsules (Rifabutin)
n=72 Participants
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.
|
|---|---|
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Number of Participants With Adverse Drug Reactions by Diagnosis
MAC (Therapeutic) and NTM Infection Other Than MAC
|
1 Participants
|
|
Number of Participants With Adverse Drug Reactions by Diagnosis
MAC (Therapeutic)
|
7 Participants
|
|
Number of Participants With Adverse Drug Reactions by Diagnosis
Tuberculosis
|
8 Participants
|
|
Number of Participants With Adverse Drug Reactions by Diagnosis
NTM Infections Other Than MAC
|
0 Participants
|
|
Number of Participants With Adverse Drug Reactions by Diagnosis
Others
|
0 Participants
|
PRIMARY outcome
Timeframe: 6.5 years (at maximum)Population: 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.
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.
Outcome measures
| Measure |
MYCOBUTIN Capsules (Rifabutin)
n=72 Participants
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.
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|---|---|
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Clinical Response Rate (Therapeutic)
|
80.6 Percentage of Participants
Interval 68.63 to 89.58
|
PRIMARY outcome
Timeframe: 6.5 years (at maximum)Population: 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.
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.
Outcome measures
| Measure |
MYCOBUTIN Capsules (Rifabutin)
n=72 Participants
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.
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|---|---|
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Clinical Response Rate (Therapeutic) by Gender
Male
|
80.0 Percentage of Participants
|
|
Clinical Response Rate (Therapeutic) by Gender
Female
|
100.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: 6.5 years (at maximum)Population: 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.
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.
Outcome measures
| Measure |
MYCOBUTIN Capsules (Rifabutin)
n=72 Participants
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.
|
|---|---|
|
Clinical Response Rate (Therapeutic) by Age
≥15 and <65 years
|
80.0 Percentage of Participants
|
|
Clinical Response Rate (Therapeutic) by Age
≥65 years
|
100.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: 6.5 years (at maximum)Population: 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.
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.
Outcome measures
| Measure |
MYCOBUTIN Capsules (Rifabutin)
n=72 Participants
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.
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|---|---|
|
Clinical Response Rate (Therapeutic) by Diagnosis
MAC (Therapeutic) and NTM Infection Other Than MAC
|
50.0 Percentage of Participants
|
|
Clinical Response Rate (Therapeutic) by Diagnosis
MAC (Therapeutic)
|
78.3 Percentage of Participants
|
|
Clinical Response Rate (Therapeutic) by Diagnosis
Tuberculosis
|
89.7 Percentage of Participants
|
|
Clinical Response Rate (Therapeutic) by Diagnosis
NTM Infections Other Than MAC
|
57.1 Percentage of Participants
|
|
Clinical Response Rate (Therapeutic) by Diagnosis
Others
|
100.0 Percentage of Participants
|
Adverse Events
MYCOBUTIN Capsules (Rifabutin)
Serious adverse events
| Measure |
MYCOBUTIN Capsules (Rifabutin)
n=72 participants at risk
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.
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|---|---|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
4.2%
3/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Infections and infestations
Arthritis bacterial
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Infections and infestations
Herpes zoster
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Infections and infestations
Cerebral toxoplasmosis
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Infections and infestations
Lung infection
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Infections and infestations
Subcutaneous abscess
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Infections and infestations
Atypical mycobacterial infection
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.8%
2/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Immune system disorders
Immune reconstitution inflammatory syndrome
|
5.6%
4/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Psychiatric disorders
Irritability
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Psychiatric disorders
Hallucination, auditory
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Psychiatric disorders
Bipolar disorder
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Psychiatric disorders
Anxiety
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Psychiatric disorders
Depressive symptom
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Eye disorders
Necrotising retinitis
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
2/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Renal and urinary disorders
Renal disorder
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
General disorders
Drug resistance
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Investigations
Platelet count decreased
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Investigations
White blood cell count decreased
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.4%
1/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
Other adverse events
| Measure |
MYCOBUTIN Capsules (Rifabutin)
n=72 participants at risk
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.
|
|---|---|
|
Infections and infestations
Herpes zoster
|
5.6%
4/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Immune system disorders
Immune reconstitution inflammatory syndrome
|
6.9%
5/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.8%
2/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.8%
2/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
2/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
4.2%
3/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
2/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Renal and urinary disorders
Renal impairment
|
5.6%
4/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
|
Investigations
Blood triglycerides increased
|
5.6%
4/72 • 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER