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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142560 | Registry Identifier | JapicCTI | |
| JapicCTI-R160837 | Other Identifier | JapicCTI |
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The purpose of this survey is designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate SR 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) in prostate cancer participants in daily medical practice.
This survey was designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate 3 months depot injection kit (Leuplin SR 11.25 mg Injection Kit) in prostate cancer participants in daily medical practice.
For adults, 11.25 mg of leuprorelin acetate is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous administration of leuprorelin acetate | Subcutaneous administration of leuprorelin acetate once every 12 weeks as daily medicinal practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprorelin acetate | Drug | Leuprorelin acetate SR 11.25 mg injection kit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | Baseline up to Week 96 |
| Number of Participants Reporting One or More Serious Adverse Drug Reactions | Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification | PFS was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=<2 centimeter (cm), T2=2-5 cm, T3=>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread >10 axillary LN, M0=no metastasis, M1= Metastasis. |
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Inclusion Criteria: Prostate cancer participants who meet all the following criteria:
Exclusion Criteria:
-
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Prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| Postmarketing Group Manager | Takeda | Study Chair |
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Participants with a historical diagnosis of prostate cancer were treated with leuprorelin acetate 11.25 milligrams (mg) in daily medical practice along with adjuvant therapy were observed.
Participants took part in the study at 758 investigative site in Japan from 13-Oct-2005 to 31-Dec-10.
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| ID | Title | Description |
|---|---|---|
| FG000 | Leuprorelin Acetate | Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set was defined as all participants who were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Leuprorelin Acetate | Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 Reporting One or More Adverse Drug Reactions | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | The safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Number | participants | Baseline up to Week 96 |
|
Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this 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 | Leuprorelin Acetate | Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | Medra (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | Medra (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Baseline up to 96 weeks |
| Percentage of Participants With Overall Survival (OS) Based on TNM Classification | OS was defined as the duration from randomization to death (due to any cause). Probability of OS was reported using Kaplan-Meier method. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=<2 centimeter (cm), T2=2-5 cm, T3=>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread >10 axillary LN, M0=no metastasis, M1= Metastasis. | Baseline up to 96 weeks or death (which ever occurs first) |
| Percentage of Participants With Metastasis-free Survival | Baseline up to 96 weeks |
| Percentage of Participants With Disease-specific Survival | Disease-specific survival is defined as time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer. | Baseline up to 96 weeks |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| Tumor Node Metastasis(TNM) Classification (at start of treatment with leuplin SR 11.25 mg injection) | TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=<2 centimeter (cm), T2=2-5 cm, T3=>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread >10 axillary LN, M0=no metastasis, M1= Metastasis. | Number | participants |
|
| Performance Status (at start of treatment with leuplin SR 11.25 mg injection) | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. | Number | participants |
|
| Predisposition to Hypersensitivity | Number | participants |
|
| Medical Complications | Participants may be represented in more than 1 category. | Number | participants |
|
| Breakdown of Complications | This baseline characteristic was analyzed in participants who had hypertension, heart disease, diabetes mellitus, hyperlipidemia, malignant tumor, cerebrovascular disease, and any other medical complications. | Number | participants |
|
| Prior Treatment for Prostate Cancer | This baseline measure was analyzed in participants who had treatment for prostate cancer prior to the start of treatment with leuplin SR 11.25 mg. Participants may be represented in more than 1 category. | Number | participants |
|
| Breakdown for Prior Treatment for Prostate Cancer | LH-RH (luteinizing hormone releasing hormone) | Number | participants |
|
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | The safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Number | participants | Baseline up to Week 96 |
|
|
|
| Secondary | Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification | PFS was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=<2 centimeter (cm), T2=2-5 cm, T3=>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread >10 axillary LN, M0=no metastasis, M1= Metastasis. | The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 96 weeks |
|
|
|
| Secondary | Percentage of Participants With Overall Survival (OS) Based on TNM Classification | OS was defined as the duration from randomization to death (due to any cause). Probability of OS was reported using Kaplan-Meier method. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=<2 centimeter (cm), T2=2-5 cm, T3=>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread >10 axillary LN, M0=no metastasis, M1= Metastasis. | The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 96 weeks or death (which ever occurs first) |
|
|
|
| Secondary | Percentage of Participants With Metastasis-free Survival | No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed. | Posted | Baseline up to 96 weeks |
|
|
| Secondary | Percentage of Participants With Disease-specific Survival | Disease-specific survival is defined as time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer. | No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed. | Posted | Baseline up to 96 weeks |
|
|
| 188 |
| 11,125 |
| 1,429 |
| 11,125 |
| Herpes zoster | Infections and infestations | Medra (17.0) | Systematic Assessment |
|
| Injection site abscess | Infections and infestations | Medra (17.0) | Systematic Assessment |
|
| Lung abscess | Infections and infestations | Medra (17.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Medra (17.0) | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | Medra (17.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Medra (17.0) | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | Medra (17.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | Medra (17.0) | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Prostate cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra (17.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Medra (17.0) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | Medra (17.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Medra (17.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Medra (17.0) | Systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | Medra (17.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Medra (17.0) | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | Medra (17.0) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | Medra (17.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | Medra (17.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Medra (17.0) | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Cerebellar haemorrhage | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Dementia | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Dyslalia | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Hyperreflexia | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Optic neuritis | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Facial nerve disorder | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Thrombotic cerebral infarction | Nervous system disorders | Medra (17.0) | Systematic Assessment |
|
| Cataract | Eye disorders | Medra (17.0) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Ventricular hypokinesia | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | Medra (17.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | Medra (17.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Medra (17.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | Medra (17.0) | Systematic Assessment |
|
| Arteriosclerosis obliterans | Vascular disorders | Medra (17.0) | Systematic Assessment |
|
| Aortic dissection rupture | Vascular disorders | Medra (17.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Vocal cord polyp | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Nocturnal dyspnoea | Respiratory, thoracic and mediastinal disorders | Medra (17.0) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | Medra (17.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Medra (17.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Medra (17.0) | Systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | Medra (17.0) | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | Medra (17.0) | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | Medra (17.0) | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | Medra (17.0) | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | Medra (17.0) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | Medra (17.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Medra (17.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | Medra (17.0) | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | Medra (17.0) | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | Medra (17.0) | Systematic Assessment |
|
| Gallbladder perforation | Hepatobiliary disorders | Medra (17.0) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | Medra (17.0) | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | Medra (17.0) | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | Medra (17.0) | Systematic Assessment |
|
| Generalised erythema | Skin and subcutaneous tissue disorders | Medra (17.0) | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | Medra (17.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Medra (17.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | Medra (17.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Medra (17.0) | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | Medra (17.0) | Systematic Assessment |
|
| Asthenia | General disorders | Medra (17.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | Medra (17.0) | Systematic Assessment |
|
| Chest pain | General disorders | Medra (17.0) | Systematic Assessment |
|
| Crepitations | General disorders | Medra (17.0) | Systematic Assessment |
|
| Death | General disorders | Medra (17.0) | Systematic Assessment |
|
| Face oedema | General disorders | Medra (17.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | Medra (17.0) | Systematic Assessment |
|
| Injection site erosion | General disorders | Medra (17.0) | Systematic Assessment |
|
| Injection site erythema | General disorders | Medra (17.0) | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | Medra (17.0) | Systematic Assessment |
|
| Injection site induration | General disorders | Medra (17.0) | Systematic Assessment |
|
| Injection site pain | General disorders | Medra (17.0) | Systematic Assessment |
|
| Injection site pruritus | General disorders | Medra (17.0) | Systematic Assessment |
|
| Injection site ulcer | General disorders | Medra (17.0) | Systematic Assessment |
|
| Injection site warmth | General disorders | Medra (17.0) | Systematic Assessment |
|
| Malaise | General disorders | Medra (17.0) | Systematic Assessment |
|
| Oedema | General disorders | Medra (17.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | Medra (17.0) | Systematic Assessment |
|
| Pyrexia | General disorders | Medra (17.0) | Systematic Assessment |
|
| Injection site swelling | General disorders | Medra (17.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Medra (17.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Medra (17.0) | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | Medra (17.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Medra (17.0) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | Medra (17.0) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | Medra (17.0) | Systematic Assessment |
|
| C-reactive protein increased | Investigations | Medra (17.0) | Systematic Assessment |
|
| Chest X-ray abnormal | Investigations | Medra (17.0) | Systematic Assessment |
|
| Computerised tomogram abnormal | Investigations | Medra (17.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Medra (17.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | Medra (17.0) | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | Medra (17.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | Medra (17.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Medra (17.0) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Medra (17.0) | Systematic Assessment |
|
| Surfactant protein increased | Investigations | Medra (17.0) | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | Medra (17.0) | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | Medra (17.0) | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | Medra (17.0) | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | Medra (17.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Medra (17.0) | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | Medra (17.0) | Systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | Medra (17.0) | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | Medra (17.0) | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | Medra (17.0) | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | Medra (17.0) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | Medra (17.0) | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | Medra (17.0) | Systematic Assessment |
|
| Injection site induration | General disorders | Medra (17.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | Medra (17.0) | Systematic Assessment |
|
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| Title | Measurements |
|---|---|
|
| Stage IV (N=2446) |
|
| Title | Measurements |
|---|---|
|
| Stage IV (N=2443) |
|