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To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice.
All the patients whom an investigator prescribes the first Azithromycin SR should be registered within 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin SR | Patients taking Azithromycin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin SR | Drug | Zithromax SR 2g, taking once for treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 29 days |
| Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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The patients whom an involving A0661202 prescribes the Azithromycin SR.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azithromycin SR | Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin SR | Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Number | participants | Baseline to 29 days |
|
Not provided
The frequency of treatment related adverse events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azithromycin SR | Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA-J 13.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D002481 | Cellulitis |
| D018461 | Soft Tissue Infections |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
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Number of participants with responders of azithromycin to determine whether <65 years or >=65 years is significant risk factor. |
| Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| 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. | Baseline to 29 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Type of Infection | The physician in charge of the survey made the diagnosis of type of infection based on symptoms. | Number | participants |
|
Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
|
|
| 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. | 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). | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | 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). | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | 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). | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | 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). | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | 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). | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | 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). | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | 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). | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | 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). | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | 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). | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | 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). | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | 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). | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 29 days |
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | Events | Baseline to 29 days |
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | Baseline to 29 days |
|
|
|
|
| 0 |
| 498 |
| 52 |
| 498 |
| Nausea | Gastrointestinal disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Face Oedema | General disorders | MedDRA-J 13.1 | Systematic Assessment |
|
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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
|
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|
|