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The objective of this surveillance is to collect information about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
All the patients whom an investigator prescribes the first Sertraline hydrochloride 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 |
|---|---|---|---|
| Sertraline hydrochloride. | Patients taking Sertraline hydrochloride. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline hydrochloride | Drug | J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan. Dosage, Frequency: According to Japanese LPD, "The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms". Duration: According to the protocol of A0501090, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 16 weeks after the first administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants of 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. Definition 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 up to 16 weeks |
| Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Baseline up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.) |
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Inclusion Criteria:
Patients need to be taking Sertraline hydrochloride in order to be enrolled in the surveillance.
Exclusion Criteria:
Patients not taking Sertraline hydrochloride.
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The patients to whom an investigator involved in A0501090 prescribes sertraline hydrochloride.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sertraline | Participants taking Sertraline according to Japanese Package Insert |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sertraline | Participants taking Sertraline 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 of 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. Definition 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. | Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline. | Posted | Number | participants | Baseline up to 16 weeks |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event 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 | Sertraline | Participants taking Sertraline according to Japanese Package Insert. All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA/14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA/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 |
|---|---|
| D016584 | Panic Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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|
|
| Baseline up to 16 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.) | Baseline up to 16 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without renal dysfunction is significant risk factor | Baseline up to 16 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without Past Medical History of Other Illness is significant risk factor | Baseline up to 16 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether average daily dose is significant risk factor | Baseline up to 16 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt) | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor | Baseline up to 16 weeks |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor | Baseline up to 16 weeks |
| Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity | Number of participants with responders of Sertraline to determine whether target disease severity is significant factor | Baseline up to 16 weeks |
| Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride | Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor | Baseline up to 16 weeks |
| Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient | Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor | Baseline up to 16 weeks |
| Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments. | Number of participants with responders of Sertraline to determine whether with or without complication is significant factor | Baseline up to 16 weeks |
| Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not | Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor | Baseline up to 16 weeks |
| Factors Considered to Affect the Efficacy of Sertraline: Age | Number of participants with responders of Sertraline to determine whether age is significant factor | Baseline up to 16 weeks |
| Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt) | Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor | Baseline up to 16 weeks |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Target Disease | The target disease which was diagnosed by investigator | Number | participants |
|
| Target Disease Severity | The severity of target disease which was diagnosed by investigator | Number | participants |
|
| Complications | Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.) | Number | participants |
|
| Concomitant Drug | Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.) | Number | participants |
|
| Starting Dose | Starting dose of each participant enrolled in this study | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | Posted | Number | events | Baseline up to 16 weeks |
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.) | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.) | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without renal dysfunction is significant risk factor | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without Past Medical History of Other Illness is significant risk factor | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether average daily dose is significant risk factor | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt) | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| Secondary | Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity | Number of participants with responders of Sertraline to determine whether target disease severity is significant factor | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| Secondary | Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride | Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| Secondary | Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient | Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| Secondary | Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments. | Number of participants with responders of Sertraline to determine whether with or without complication is significant factor | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| Secondary | Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not | Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| Secondary | Factors Considered to Affect the Efficacy of Sertraline: Age | Number of participants with responders of Sertraline to determine whether age is significant factor | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| Secondary | Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt) | Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | Posted | Number | participants | Baseline up to 16 weeks |
|
|
|
|
| 9 |
| 2,157 |
| 263 |
| 2,157 |
| Dissociative disorder | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Serotonin syndrome | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Neuroleptic malignant syndrome | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA/14.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA/14.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA/14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/14.1 | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA/14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA/14.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA/14.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA/14.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA/14.1 | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/14.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA/14.1 | Systematic Assessment |
|
| Ejaculation delayed | Reproductive system and breast disorders | MedDRA/14.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA/14.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Serotonin syndrome | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA/14.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/14.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA/14.1 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA/14.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA/14.1 | Systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA/14.1 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA/14.1 | Systematic Assessment |
|
| Activation syndrome | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Dissociative disorder | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Intentional self-injury | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Delusion | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Withdrawal syndrome | Psychiatric disorders | MedDRA/14.1 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Neuroleptic malignant syndrome | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Dysstasia | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA/14.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA/14.1 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA/14.1 | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA/14.1 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA/14.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA/14.1 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA/14.1 | Systematic Assessment |
|
| Sexual dysfunction | Reproductive system and breast disorders | MedDRA/14.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA/14.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA/14.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA/14.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA/14.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA/14.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA/14.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA/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.
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Erectile dysfunction |
|