Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections, Non-tuberculous Mycobacterial Diseases, Tuberculosis
Conditions
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.
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.
Interventions
DRUGrifabutin
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..
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 72 |
| Total | 72 |
Baseline characteristics
| Characteristic | MYCOBUTIN Capsules (Rifabutin) |
|---|---|
| Age, Customized ≥15 and <65 years | 69 Participants |
| Age, Customized <15 years | 0 Participants |
| Age, Customized ≥65 years | 3 Participants |
| Diagnosis MAC (Preventive) | 0 Participants |
| Diagnosis MAC (Therapeutic) | 31 Participants |
| Diagnosis MAC (Therapeutic) and NTM Infection Other Than MAC | 2 Participants |
| Diagnosis NTM Infection Other Than MAC | 8 Participants |
| Diagnosis Others | 1 Participants |
| Diagnosis Tuberculosis | 30 Participants |
| Race/Ethnicity, Customized Japanese | 64 Participants |
| Race/Ethnicity, Customized Others | 8 Participants |
| Sex/Gender, Customized Female | 3 Participants |
| Sex/Gender, Customized Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 72 |
| other Total, other adverse events | 28 / 72 |
| serious Total, serious adverse events | 15 / 72 |
Outcome results
Primary
Clinical Response Rate (Therapeutic)
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)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MYCOBUTIN Capsules (Rifabutin) | Clinical Response Rate (Therapeutic) | 80.6 Percentage of Participants |
Primary
Clinical Response Rate (Therapeutic) by Age
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)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MYCOBUTIN Capsules (Rifabutin) | Clinical Response Rate (Therapeutic) by Age | ≥15 and <65 years | 80.0 Percentage of Participants |
| MYCOBUTIN Capsules (Rifabutin) | Clinical Response Rate (Therapeutic) by Age | ≥65 years | 100.0 Percentage of Participants |
| Unknown | Clinical Response Rate (Therapeutic) by Age | <15 years | — Percentage of Participants |
Primary
Clinical Response Rate (Therapeutic) by Diagnosis
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)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MYCOBUTIN Capsules (Rifabutin) | Clinical Response Rate (Therapeutic) by Diagnosis | MAC (Therapeutic) | 78.3 Percentage of Participants |
| MYCOBUTIN Capsules (Rifabutin) | Clinical Response Rate (Therapeutic) by Diagnosis | Tuberculosis | 89.7 Percentage of Participants |
| MYCOBUTIN Capsules (Rifabutin) | Clinical Response Rate (Therapeutic) by Diagnosis | NTM Infections Other Than MAC | 57.1 Percentage of Participants |
| MYCOBUTIN Capsules (Rifabutin) | Clinical Response Rate (Therapeutic) by Diagnosis | MAC (Therapeutic) and NTM Infection Other Than MAC | 50.0 Percentage of Participants |
| MYCOBUTIN Capsules (Rifabutin) | Clinical Response Rate (Therapeutic) by Diagnosis | Others | 100.0 Percentage of Participants |
Primary
Clinical Response Rate (Therapeutic) by Gender
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)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MYCOBUTIN Capsules (Rifabutin) | Clinical Response Rate (Therapeutic) by Gender | Male | 80.0 Percentage of Participants |
| MYCOBUTIN Capsules (Rifabutin) | Clinical Response Rate (Therapeutic) by Gender | Female | 100.0 Percentage of Participants |
Primary
Number of Participants With Adverse Drug Reactions by Age
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)
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MYCOBUTIN Capsules (Rifabutin) | Number of Participants With Adverse Drug Reactions by Age | ≥15 and <65 years | 16 Participants |
| MYCOBUTIN Capsules (Rifabutin) | Number of Participants With Adverse Drug Reactions by Age | ≥65 years | 0 Participants |
| Unknown | Number of Participants With Adverse Drug Reactions by Age | <15 years | — Participants |
Primary
Number of Participants With Adverse Drug Reactions by Diagnosis
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)
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MYCOBUTIN Capsules (Rifabutin) | Number of Participants With Adverse Drug Reactions by Diagnosis | MAC (Therapeutic) | 7 Participants |
| MYCOBUTIN Capsules (Rifabutin) | Number of Participants With Adverse Drug Reactions by Diagnosis | Tuberculosis | 8 Participants |
| MYCOBUTIN Capsules (Rifabutin) | Number of Participants With Adverse Drug Reactions by Diagnosis | NTM Infections Other Than MAC | 0 Participants |
| MYCOBUTIN Capsules (Rifabutin) | Number of Participants With Adverse Drug Reactions by Diagnosis | MAC (Therapeutic) and NTM Infection Other Than MAC | 1 Participants |
| MYCOBUTIN Capsules (Rifabutin) | Number of Participants With Adverse Drug Reactions by Diagnosis | Others | 0 Participants |
Primary
Number of Participants With Adverse Drug Reactions by Gender
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)
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MYCOBUTIN Capsules (Rifabutin) | Number of Participants With Adverse Drug Reactions by Gender | Male | 16 Participants |
| MYCOBUTIN Capsules (Rifabutin) | Number of Participants With Adverse Drug Reactions by Gender | Female | 0 Participants |
Primary
Number of Patients With Adverse Drug Reactions in This Surveillance
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)
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MYCOBUTIN Capsules (Rifabutin) | Number of Patients With Adverse Drug Reactions in This Surveillance | ADR | 16 Participants |
| MYCOBUTIN Capsules (Rifabutin) | Number of Patients With Adverse Drug Reactions in This Surveillance | Serious ADR | 7 Participants |
Primary
The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions)
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)
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MYCOBUTIN Capsules (Rifabutin) | The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions) | 7 Participants |