Trial Outcomes & Findings for Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan) (NCT NCT00998309)

NCT ID: NCT00998309

Last Updated: 2012-05-01

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 502 participants
• Primary outcome timeframe: Baseline to 29 days
• Results posted on: 2012-05-01

Participant Flow

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.

Participant milestones

Measure	Azithromycin SR Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Overall Study STARTED	502
Overall Study COMPLETED	498
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Azithromycin SR Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Overall Study Protocol Violation	4

Baseline Characteristics

Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)

Baseline characteristics by cohort

Measure	Azithromycin SR n=498 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Age, Customized	39.9 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	211 Participants n=5 Participants
Sex: Female, Male Male	287 Participants n=5 Participants
Type of Infection Skin and Soft Tissue Infection	104 participants n=5 Participants
Type of Infection Sexual Transmitted Infection	199 participants n=5 Participants
Type of Infection Dental and Oral Surgery Infection	183 participants n=5 Participants
Type of Infection Others	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Azithromycin SR n=457 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
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	—	—
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	Azithromycin SR n=498 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Number of Participants With Treatment Related Adverse Events (TRAEs) Number of Participants without TRAEs	446 participants	—	—
Number of Participants With Treatment Related Adverse Events (TRAEs) Number of Participants with TRAEs	52 participants	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Azithromycin SR n=498 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Number of Unlisted Treatment Related Adverse Events (TRAEs) Number of Treatment Related AEs Analyzed	61 Events	—	—
Number of Unlisted Treatment Related Adverse Events (TRAEs) Number of Unlisted Treatment Related AEs	2 Events	—	—

SECONDARY outcome

Timeframe: 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).

Number of participants with responders of azithromycin to determine whether male or female is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=272 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=185 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender Number of participants	272 participants	185 participants	—
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender Participatns of Responders	254 participants	184 participants	—

SECONDARY outcome

Timeframe: 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).

Number of participants with responders of azithromycin to determine whether <65 years or >=65 years is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=414 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=43 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age Number of participants	414 participants	43 participants	—
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age Participatns of Responders	396 participants	42 participants	—

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Azithromycin SR n=96 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=199 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection n=162 Participants Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection Number of participants	96 participants	199 participants	162 participants
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection Participatns of Responders	95 participants	181 participants	162 participants

SECONDARY outcome

Timeframe: 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).

Number of participants with responders of azithromycin to determine whether Infection severity, "mild infection, moderate infection, or severe infection", is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=152 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=260 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection n=45 Participants Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity Number of Participants	152 participants	260 participants	45 participants
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity Participatns of Responders	147 participants	247 participants	44 participants

SECONDARY outcome

Timeframe: 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).

Number of participants with responders of azithromycin to determine whether with or without hepatic dysfunction is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=395 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=2 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD) Number of Participants	395 participants	2 participants	—
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD) Participatns of Responders	381 participants	1 participants	—

SECONDARY outcome

Timeframe: 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).

Number of participants with responders of azithromycin to determine whether with or without renal dysfunction is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=397 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=1 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD) Number of Participants	397 participants	1 participants	—
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD) Participatns of Responders	382 participants	1 participants	—

SECONDARY outcome

Timeframe: 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).

Number of participants with responders of azithromycin to determine whether with or without past medical history is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=441 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=16 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH) Number of Participants	441 participants	16 participants	—
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH) Participatns of Responders	422 participants	16 participants	—

SECONDARY outcome

Timeframe: 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).

Number of participants with responders of azithromycin to determine whether with or without complications is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=408 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=49 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications Number of Participants	408 participants	49 participants	—
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications Participatns of Responders	391 participants	47 participants	—

SECONDARY outcome

Timeframe: 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).

Number of participants with responders of azithromycin to determine whether with or without previous antibiotic treatment history is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=441 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=16 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH) Number of Participants	441 participants	16 participants	—
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH) Participatns of Responders	422 participants	16 participants	—

SECONDARY outcome

Timeframe: 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).

Number of participants with responders of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=284 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=173 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD) Number of Participants	284 participants	173 participants	—
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD) Participatns of Responders	274 participants	164 participants	—

SECONDARY outcome

Timeframe: 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).

Number of participants with responders of azithromycin to determine whether with or without non-drug therapy is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=423 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=34 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy Number of Participants	423 participants	34 participants	—
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy Participatns of Responders	405 participants	33 participants	—

SECONDARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether male or female is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=287 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=211 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender Number of Participants	287 participants	211 participants	—
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender Number of Participants with TRAEs	32 participants	20 participants	—

SECONDARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether <65 years or >=65 years is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=448 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=50 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age Number of Participants	448 participants	50 participants	—
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age Number of Participants with TRAEs	50 participants	2 participants	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Azithromycin SR n=104 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=199 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection n=183 Participants Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection Number of Participants	104 participants	199 participants	183 participants
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection Number of Participants with TRAEs	2 participants	24 participants	26 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Azithromycin SR n=168 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=283 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection n=47 Participants Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity Number of Participants	168 participants	283 participants	47 participants
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity Number of Participants with TRAEs	19 participants	25 participants	8 participants

SECONDARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Hepatic Dysfunction is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=422 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=2 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction Number of Participants	422 participants	2 participants	—
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction Number of Participants with TRAEs	48 participants	0 participants	—

SECONDARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Renal Dysfunction is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=423 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=1 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction Number of Participants	423 participants	1 participants	—
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction Number of Participants with TRAEs	48 participants	1 participants	—

SECONDARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Past Medical History is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=481 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=17 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History Number of Participants	481 participants	17 participants	—
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History Number of Participants with TRAEs	42 participants	10 participants	—

SECONDARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without complications is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=441 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=57 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications Number of Participants	441 participants	57 participants	—
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications Number of Participants with TRAEs	45 participants	7 participants	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Azithromycin SR n=481 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=16 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH) Number of Participants	481 participants	16 participants	—
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	2 participants	—

SECONDARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=298 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=200 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs Number of Participants	298 participants	200 participants	—
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs Number of Participants with TRAEs	27 participants	25 participants	—

SECONDARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without non-drug therapy is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=463 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=35 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy Number of Participants	463 participants	35 participants	—
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy Number of Participants with TRAEs	52 participants	0 participants	—

SECONDARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Pregnancy in Female is significant risk factor.

Outcome measures

Measure	Azithromycin SR n=199 Participants Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Azithromycin-Female n=11 Participants Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.	Aazithromycin-Dental and Oral Surgery Infection Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female Number of Participants	199 participants	11 participants	—
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female Number of Participants with TRAEs	20 participants	0 participants	—

Adverse Events

Azithromycin SR

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Azithromycin SR n=498 participants at risk Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
Gastrointestinal disorders Diarrhea	8.8% 44/498 • Number of events 44 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Nausea	0.80% 4/498 • Number of events 4 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Enterocolitis	0.60% 3/498 • Number of events 3 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Vomiting	0.60% 3/498 • Number of events 3 The frequency of treatment related adverse events during the study.
Blood and lymphatic system disorders Lymphadenopathy	0.20% 1/498 • Number of events 1 The frequency of treatment related adverse events during the study.
Blood and lymphatic system disorders Lymph node pain	0.20% 1/498 • Number of events 1 The frequency of treatment related adverse events during the study.
Metabolism and nutrition disorders Decreased Appetite	0.20% 1/498 • Number of events 1 The frequency of treatment related adverse events during the study.
Nervous system disorders Dizziness	0.20% 1/498 • Number of events 1 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Gastritis	0.20% 1/498 • Number of events 1 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Abdominal Pain	0.20% 1/498 • Number of events 1 The frequency of treatment related adverse events during the study.
General disorders Face Oedema	0.20% 1/498 • Number of events 1 The frequency of treatment related adverse events during the study.

Additional Information

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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