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| Name | Class |
|---|---|
| Altmarc Inc. | INDUSTRY |
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The investigation will be conducted for the purpose of determining the condition of occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet, verifying the therapeutic effects, detecting unknown Adverse Drug Reactions and drug interactions and determining the factors affecting safety and efficacy.
All the patients whom an investigator prescribes the first Zithromac Tablets 600mg should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin | Patients taking Azithromycin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Inhibition of onset: Perorally administer 1200mg of azithromycin (potency) once a week to adults. Treatment: Perorally administer 600mg of azithromycin (potency) once a day to adults. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Frequency of Treatment Related Adverse Events. | Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Azithromycin. | 9 years(MAX) |
| Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. | Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Azithromycin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. | 9 years(MAX) |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor. | 9 years(MAX) |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor. | 9 years(MAX) |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Responded to Azithromycin Treatment. | The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results. | 9 years(MAX) |
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Inclusion Criteria:
Patients need to be administered Zithromac Tablets 600mg in order to be enrolled in the surveillance.
Exclusion Criteria:
Patients not administered Zithromac Tablets 600mg.
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The subjects whom an investigator involving A0661097 prescribes the Azithromycin Tablets 600mg (Zithromac Tablets 600mg).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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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 for Prophylaxis | Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert. |
| FG001 | Azithromycin for Treatment | Participants taking Azithromycin for Treatment according to Japanese Package Insert. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin for Prophylaxis | Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert. |
| BG001 | Azithromycin for Treatment | Participants taking Azithromycin for Treatment 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 | Number |
| 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 the Frequency of Treatment Related Adverse Events. | Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Azithromycin. | No statistical analysis provided for the frequency of treatment related adverse events. | Posted | Number | participants | 9 years(MAX) |
|
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The frequency of treatment related advers 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 for Prophylaxis | Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA-J 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis C | Infections and infestations | MedDRA-J 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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|
| 9 years(MAX) |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor. | 9 years(MAX) |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor. | 9 years(MAX) |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor. | 9 years(MAX) |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor. | 9 years(MAX) |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor. | 9 years(MAX) |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor. | 9 years(MAX) |
| Number of Participants Prevented by Azithromycin Treatment. |
The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results. |
| 9 years(MAX) |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants taking Azithromycin for Treatment according to Japanese Package Insert. |
|
|
| Primary | Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. | Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Azithromycin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. | No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert. | Posted | Number | Events | 9 years(MAX) |
|
|
|
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis). | 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 cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 9 years(MAX) |
|
|
|
|
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 9 years(MAX) |
|
|
|
|
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drugs was confirmed. | Posted | Number | participants | 9 years(MAX) |
|
|
|
|
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis). | 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 cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 9 years(MAX) |
|
|
|
|
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 9 years(MAX) |
|
|
|
|
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment). | 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 cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 9 years(MAX) |
|
|
|
|
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 9 years(MAX) |
|
|
|
|
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment). | 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 cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 9 years(MAX) |
|
|
|
|
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment). | Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 9 years(MAX) |
|
|
|
|
| Secondary | Number of Participants That Responded to Azithromycin Treatment. | The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results. | 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 | 9 years(MAX) |
|
|
|
| Secondary | Number of Participants Prevented by Azithromycin Treatment. | The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results. | 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 | 9 years(MAX) |
|
|
|
| 11 |
| 391 |
| 62 |
| 391 |
| EG001 | Azithromycin for Treatment | Participants taking Azithromycin for Treatment according to Japanese Package Insert. | 4 | 84 | 6 | 84 |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Duodenal stenosis | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA-J 14.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Duodenal ulcer | General disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Lipodystrophy acquired | Skin and subcutaneous tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Sexual dysfunction | Reproductive system and breast disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Beta 2 microglobulin urine increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA-J 14.1 | 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.
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Organic Chemicals |