Bacterial Infections
Conditions
Keywords
skin infection, soft tissue infection, sexually-transmitted infection, infection oral, Regulatory Post Marketing Commitment Plan
Brief summary
To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice.
Detailed description
All the patients whom an investigator prescribes the first Azithromycin SR should be registered within 14 days.
Interventions
DRUGAzithromycin SR
Zithromax SR 2g, taking once for treatment.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or female subjects diagnosed with skin and soft tissue infection, sexually-transmitted infection, and infection of the oral. * Subjects must have no prior experience with Azithromycin SR.
Exclusion criteria
* Patients not administered Azithromycin SR.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study. | Baseline to 29 days | The physician in charge of the survey performed comprehensive clinical effect evaluation on result of clinical findings, bacteriological effect and others. Clinical effect (Effective (cured)/ Not effective (not cured)/ unable to evaluate effectiveness evaluation) was performed at visits during the observation period by comparing to the data before administration of this drug.Criteria of cured was disappearance or improvement of clinical findings with infections and/or causal bacterial disappearance. |
| Number of Participants With Treatment Related Adverse Events (TRAEs) | Baseline to 29 days | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. |
| Number of Unlisted Treatment Related Adverse Events (TRAEs) | Baseline to 29 days | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection | Baseline to 29 days | Number of participants with responders of azithromycin to determine whether type of infection, Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental and Oral Surgery Infection, is significant risk factor. |
| Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity | Baseline to 29 days | Number of participants with responders of azithromycin to determine whether Infection severity, mild infection, moderate infection, or severe infection, is significant risk factor. |
| Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD) | Baseline to 29 days | Number of participants with responders of azithromycin to determine whether with or without renal dysfunction is significant risk factor. |
| Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH) | Baseline to 29 days | Number of participants with responders of azithromycin to determine whether with or without past medical history is significant risk factor. |
| Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications | Baseline to 29 days | Number of participants with responders of azithromycin to determine whether with or without complications is significant risk factor. |
| Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH) | Baseline to 29 days | Number of participants with responders of azithromycin to determine whether with or without previous antibiotic treatment history is significant risk factor. |
| Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD) | Baseline to 29 days | Number of participants with responders of azithromycin to determine whether with or without comcomittant drugs is significant risk factor. |
| Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy | Baseline to 29 days | Number of participants with responders of azithromycin to determine whether with or without non-drug therapy is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender | Baseline to 29 days | Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether male or female is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age | Baseline to 29 days | Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether \<65 years or \>=65 years is significant risk factor. |
| Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD) | Baseline to 29 days | Number of participants with responders of azithromycin to determine whether with or without hepatic dysfunction is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity | Baseline to 29 days | Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether mild infection, moderate infection, or severe infection is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction | Baseline to 29 days | Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Hepatic Dysfunction is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction | Baseline to 29 days | Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Renal Dysfunction is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History | Baseline to 29 days | Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Past Medical History is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications | Baseline to 29 days | Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without complications is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH) | Baseline to 29 days | Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without previous antibioutic treatment history (PATH) is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs | Baseline to 29 days | Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without comcomittant drugs is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy | Baseline to 29 days | Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without non-drug therapy is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female | Baseline to 29 days | Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Pregnancy in Female is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection | Baseline to 29 days | Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether Type of Infection, Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infection, is significant risk factor. |
| Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender | Baseline to 29 days | Number of participants with responders of azithromycin to determine whether male or female is significant risk factor. |
| Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age | Baseline to 29 days | Number of participants with responders of azithromycin to determine whether \<65 years or \>=65 years is significant risk factor. |
Participant flow
Recruitment details
This was a phase 4, observational, open-label study conducted in participants who were prescribed azithromycin by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.
Participants by arm
| Arm | Count |
|---|---|
| Azithromycin SR Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert. | 498 |
| Total | 498 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 4 |
Baseline characteristics
| Characteristic | Azithromycin SR |
|---|---|
| Age, Customized | 39.9 years STANDARD_DEVIATION 15.6 |
| Sex: Female, Male Female | 211 Participants |
| Sex: Female, Male Male | 287 Participants |
| Type of Infection Dental and Oral Surgery Infection | 183 participants |
| Type of Infection Others | 12 participants |
| Type of Infection Sexual Transmitted Infection | 199 participants |
| Type of Infection Skin and Soft Tissue Infection | 104 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 52 / 498 |
| serious Total, serious adverse events | 0 / 498 |
Outcome results
Primary
Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.
The physician in charge of the survey performed comprehensive clinical effect evaluation on result of clinical findings, bacteriological effect and others. Clinical effect (Effective (cured)/ Not effective (not cured)/ unable to evaluate effectiveness evaluation) was performed at visits during the observation period by comparing to the data before administration of this drug.Criteria of cured was disappearance or improvement of clinical findings with infections and/or causal bacterial disappearance.
Time frame: Baseline to 29 days
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study. | Effective (cured) | 438 participants |
| Azithromycin SR | Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study. | Not effective (not cured) | 19 participants |
Primary
Number of Participants With Treatment Related Adverse Events (TRAEs)
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Number of Participants With Treatment Related Adverse Events (TRAEs) | Number of Participants with TRAEs | 52 participants |
| Azithromycin SR | Number of Participants With Treatment Related Adverse Events (TRAEs) | Number of Participants without TRAEs | 446 participants |
Primary
Number of Unlisted Treatment Related Adverse Events (TRAEs)
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Number of Unlisted Treatment Related Adverse Events (TRAEs) | Number of Treatment Related AEs Analyzed | 61 Events |
| Azithromycin SR | Number of Unlisted Treatment Related Adverse Events (TRAEs) | Number of Unlisted Treatment Related AEs | 2 Events |
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether \<65 years or \>=65 years is significant risk factor.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age | Number of Participants | 448 participants |
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age | Number of Participants with TRAEs | 50 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age | Number of Participants | 50 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age | Number of Participants with TRAEs | 2 participants |
Comparison: The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years or \>=65 in the Incidence Rate of Treatment Related Adverse Events (TRAEs).p-value: =0.145Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs | Number of Participants | 298 participants |
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs | Number of Participants with TRAEs | 27 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs | Number of Participants | 200 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs | Number of Participants with TRAEs | 25 participants |
Comparison: The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the Incidence Rate of Treatment Related Adverse Events (TRAEs).p-value: =0.234Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without complications is significant risk factor.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications | Number of Participants | 441 participants |
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications | Number of Participants with TRAEs | 45 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications | Number of Participants | 57 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications | Number of Participants with TRAEs | 7 participants |
Comparison: The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the Incidence Rate of Treatment Related Adverse Events (TRAEs).p-value: =0.645Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether male or female is significant risk factor.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender | Number of Participants | 287 participants |
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender | Number of Participants with TRAEs | 32 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender | Number of Participants | 211 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender | Number of Participants with TRAEs | 20 participants |
Comparison: The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the Incidence Rate of Treatment Related Adverse Events (TRAEs).p-value: =0.657Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Hepatic Dysfunction is significant risk factor.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction | Number of Participants | 422 participants |
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction | Number of Participants with TRAEs | 48 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction | Number of Participants | 2 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction | Number of Participants with TRAEs | 0 participants |
Comparison: The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs).p-value: =1Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether mild infection, moderate infection, or severe infection is significant risk factor.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity | Number of Participants | 168 participants |
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity | Number of Participants with TRAEs | 19 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity | Number of Participants | 283 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity | Number of Participants with TRAEs | 25 participants |
| Aazithromycin-Dental and Oral Surgery Infection | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity | Number of Participants | 47 participants |
| Aazithromycin-Dental and Oral Surgery Infection | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity | Number of Participants with TRAEs | 8 participants |
Comparison: The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, or severe infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs).p-value: =0.213Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without non-drug therapy is significant risk factor.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy | Number of Participants | 463 participants |
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy | Number of Participants with TRAEs | 52 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy | Number of Participants | 35 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy | Number of Participants with TRAEs | 0 participants |
Comparison: The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the Incidence Rate of Treatment Related Adverse Events (TRAEs).p-value: =0.039Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Past Medical History is significant risk factor.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History | Number of Participants | 481 participants |
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History | Number of Participants with TRAEs | 42 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History | Number of Participants | 17 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History | Number of Participants with TRAEs | 10 participants |
Comparison: The risk factor tested was Past Medical History. The null hypothesis is there is no difference between with and without Past Medical History in the Incidence Rate of Treatment Related Adverse Events (TRAEs).p-value: <0.001Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Pregnancy in Female is significant risk factor.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female | Number of Participants with TRAEs | 20 participants |
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female | Number of Participants | 199 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female | Number of Participants | 11 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female | Number of Participants with TRAEs | 0 participants |
Comparison: The risk factor tested was Pregnancy in Female. The null hypothesis is there is no difference between with and without Pregnancy in the Incidence Rate of Treatment Related Adverse Events (TRAEs) in Female.p-value: =0.605Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH)
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without previous antibioutic treatment history (PATH) is significant risk factor.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH) | Number of Participants | 481 participants |
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH) | Number of Participants with TRAEs | 50 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH) | Number of Participants | 16 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH) | Number of Participants with TRAEs | 2 participants |
Comparison: The risk factor tested was previous antibiotic treatment history (PATH). The null hypothesis is there is no difference between with and without previous antibiotic treatment history (PTH) in the Incidence Rate of Treatment Related Adverse Events (TRAEs).p-value: =0.679Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Renal Dysfunction is significant risk factor.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction | Number of Participants | 423 participants |
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction | Number of Participants with TRAEs | 48 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction | Number of Participants | 1 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction | Number of Participants with TRAEs | 1 participants |
Comparison: The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs).p-value: =0.116Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether Type of Infection, Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infection, is significant risk factor.
Time frame: Baseline to 29 days
Population: The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection | Number of Participants | 104 participants |
| Azithromycin SR | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection | Number of Participants with TRAEs | 2 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection | Number of Participants | 199 participants |
| Azithromycin-Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection | Number of Participants with TRAEs | 24 participants |
| Aazithromycin-Dental and Oral Surgery Infection | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection | Number of Participants | 183 participants |
| Aazithromycin-Dental and Oral Surgery Infection | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection | Number of Participants with TRAEs | 26 participants |
Comparison: The risk factor tested was Type of Infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental or Oral Surgery Infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs).p-value: =0.005Fisher Exact
Secondary
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age
Number of participants with responders of azithromycin to determine whether \<65 years or \>=65 years is significant risk factor.
Time frame: Baseline to 29 days
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age | Number of participants | 414 participants |
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age | Participatns of Responders | 396 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age | Number of participants | 43 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age | Participatns of Responders | 42 participants |
Comparison: The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participatns of responders.p-value: =1Fisher Exact
Secondary
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD)
Number of participants with responders of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.
Time frame: Baseline to 29 days
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD) | Number of Participants | 284 participants |
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD) | Participatns of Responders | 274 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD) | Number of Participants | 173 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD) | Participatns of Responders | 164 participants |
Comparison: The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the participatns of responders.p-value: =0.47Fisher Exact
Secondary
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications
Number of participants with responders of azithromycin to determine whether with or without complications is significant risk factor.
Time frame: Baseline to 29 days
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications | Number of Participants | 408 participants |
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications | Participatns of Responders | 391 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications | Number of Participants | 49 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications | Participatns of Responders | 47 participants |
Comparison: The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participatns of responders.p-value: =1Fisher Exact
Secondary
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender
Number of participants with responders of azithromycin to determine whether male or female is significant risk factor.
Time frame: Baseline to 29 days
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender | Number of participants | 272 participants |
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender | Participatns of Responders | 254 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender | Number of participants | 185 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender | Participatns of Responders | 184 participants |
Comparison: The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participatns of responders.p-value: =0.001Fisher Exact
Secondary
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)
Number of participants with responders of azithromycin to determine whether with or without hepatic dysfunction is significant risk factor.
Time frame: Baseline to 29 days
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD) | Number of Participants | 395 participants |
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD) | Participatns of Responders | 381 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD) | Number of Participants | 2 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD) | Participatns of Responders | 1 participants |
Comparison: The risk factor tested was hepatic dysfunction. The null hypothesis is there is no difference between with and without hepatic dysfunction in the participatns of responders.p-value: =0.074Fisher Exact
Secondary
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity
Number of participants with responders of azithromycin to determine whether Infection severity, mild infection, moderate infection, or severe infection, is significant risk factor.
Time frame: Baseline to 29 days
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity | Number of Participants | 152 participants |
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity | Participatns of Responders | 147 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity | Number of Participants | 260 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity | Participatns of Responders | 247 participants |
| Aazithromycin-Dental and Oral Surgery Infection | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity | Number of Participants | 45 participants |
| Aazithromycin-Dental and Oral Surgery Infection | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity | Participatns of Responders | 44 participants |
Comparison: The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, and severe infection in the participatns of responders.p-value: =0.556Fisher Exact
Secondary
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy
Number of participants with responders of azithromycin to determine whether with or without non-drug therapy is significant risk factor.
Time frame: Baseline to 29 days
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy | Number of Participants | 423 participants |
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy | Participatns of Responders | 405 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy | Number of Participants | 34 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy | Participatns of Responders | 33 participants |
Comparison: The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the participatns of responders.p-value: =1Fisher Exact
Secondary
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH)
Number of participants with responders of azithromycin to determine whether with or without past medical history is significant risk factor.
Time frame: Baseline to 29 days
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH) | Number of Participants | 441 participants |
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH) | Participatns of Responders | 422 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH) | Number of Participants | 16 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH) | Participatns of Responders | 16 participants |
Comparison: The risk factor tested was Past medical history. The null hypothesis is there is no difference between with and without past medical history in the participatns of responders.p-value: =1Fisher Exact
Secondary
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH)
Number of participants with responders of azithromycin to determine whether with or without previous antibiotic treatment history is significant risk factor.
Time frame: Baseline to 29 days
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH) | Number of Participants | 441 participants |
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH) | Participatns of Responders | 422 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH) | Number of Participants | 16 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH) | Participatns of Responders | 16 participants |
Comparison: The risk factor tested was previous antibiotic treatment history. The null hypothesis is there is no difference between with and without previous antibiotic treatment history in the participatns of responders.p-value: =1Fisher Exact
Secondary
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD)
Number of participants with responders of azithromycin to determine whether with or without renal dysfunction is significant risk factor.
Time frame: Baseline to 29 days
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD) | Number of Participants | 397 participants |
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD) | Participatns of Responders | 382 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD) | Number of Participants | 1 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD) | Participatns of Responders | 1 participants |
Comparison: The risk factor tested was Renal dysfunction. The null hypothesis is there is no difference between with and without Renal dysfunction in the participatns of responders.p-value: =1Fisher Exact
Secondary
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection
Number of participants with responders of azithromycin to determine whether type of infection, Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental and Oral Surgery Infection, is significant risk factor.
Time frame: Baseline to 29 days
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection | Number of participants | 96 participants |
| Azithromycin SR | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection | Participatns of Responders | 95 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection | Number of participants | 199 participants |
| Azithromycin-Female | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection | Participatns of Responders | 181 participants |
| Aazithromycin-Dental and Oral Surgery Infection | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection | Number of participants | 162 participants |
| Aazithromycin-Dental and Oral Surgery Infection | Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection | Participatns of Responders | 162 participants |
Comparison: The risk factor tested was type of infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental and Oral Surgery Infection in the participatns of responders.p-value: <0.001Fisher Exact