Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Symptoms and General Pathology

Uterine Cervical Neoplasms

Communicable Diseases

All Drugs and Chemicals

Vaccines

Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.

Subjects will receive three doses of the Cervarix vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in routine clinical practice settings.

Cervarix.

All adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards.

Data collection

GSK Clinical Trials

This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs Administration (KFDA).

Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females

Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix® When Administered to Healthy Females According to the Prescribing Information in Korea

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Note: Results for the 5th and 6th year of surveillance will be added when they become available.

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

Note: Results for the 5th and 6th year of surveillance will be added when they become available.

\*Note: For Surveillance Year 3 the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.

MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

GlaxoSmithKline

Only adverse events with a frequency of over 5% were listed.

Subjects enrolled for surveillance Year 6, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.

Cervarix Group

Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.

The baseline measure data here corresponds to Year 3 of surveillance.

A total of 105 participants were included in the Year 3 surveillance.

Age, Continuous

The baseline measure data here corresponds to Year 4 of surveillance.

A total of 569 participants were included in the Year 4 surveillance.

The baseline measure data here corresponds to Year 5 of surveillance.

A total of 809 participants were included in the Year 5 surveillance.

The baseline measure data here corresponds to Year 6 of surveillance.

Sex: Female, Male

GSK Response Center

The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Any SAEs

Related SAEs

Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.

\*Note: the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.

Number of Subjects With Medically Significant Conditions.

Subjects with any MSCs, Year 4 (N=569)

Subjects with any MSCs, Year 5 (N=809)

Subjects with any MSCs, Year 6 (N=3091)

Subjects who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.

Year 3 Surveillance Period

Year 4 Surveillance Period

Year 5 Surveillance Period

Year 6 Surveillance Period

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Lenalidomide

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

All Korean patients intended to be treated with REVLIMID® according to the approved package insert

The recommended starting dose of REVLIMID® is 25mg/day with water orally administered as a single 25mg capsule on Days 1-21 of repeated 28-day cycles. Dose can be adjusted upon the clinical laboratory result.

REVLIMID®

The recommended dose of dexamethasone is 40mg/day on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the 4 cycle of therapy and then 40mg/day orally on Days 1-4 every 28 days.

Miran Moon

The main purpose of REVLIMID® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean Multiple Myeloma patients treated with REVLIMID® according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy information of REVLIMID® in clinical practice is collected and evaluated. This DUE is a multi-centre, observational and non-interventional post-marketing surveillance.

The patients can be recruited through both Drug Use Examination after the initiation of Post Marketing Surveillance(contract with institution) and Patient Access Program(PAP) that was performed before REVLIMID® reimbursement.

Total 624 patient has enrolled in PMS by 07Sep2016. Validation process for eligibility for safety assessment has been conducted by site monitoring process by 07Dec2016.

REVLIMID® DUE is to investigate frequency and change of Adverse Events(AEs) /Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety \& efficacy of the drug.

It is necessary to examine patients' demographics and baseline characteristics, medical history, status of REVLIMID® treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.

A Study to Collect and Evaluate the Safety and Efficacy Information of Korean Multiple Myeloma Patients Treated With REVLIMID®, After Approval of Marketing Authorization for New Drug in Korea

REVLIMID® Drug Use Examination

Number of participants with adverse events

Number of participants with response based on International Myeloma Working Group Criteria for Multiple Myeloma

Celgene

Syndrome

Lymphoma

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Preleukemia

Myelodysplastic Syndromes

Lymphatic Diseases

Bone Marrow Diseases

Precancerous Conditions

Lymphoma, Non-Hodgkin

Lymphosarcoma

Mantle Cell Lymphoma

Follicular Lymphoma

Chromosome 5q Deletion

Antirheumatic Agents

Rituximab

For the IPSS Low- or intermediate-1-risk del (5q) (MDS), Lenalidomide treatment must not be started if the ANC \< 0.5 x 109/L and/or platelet counts \< 25 x 109/L. The recommended starting dose of lenalidomide is 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles.

For the Refractory/relapsed Mantle cell lymphoma (rrMCL), the recommended starting dose of lenalidomide is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles. For the Follicular lymphoma (FL), the recommended starting dose of rituximab is 375 mg/m2 intravenously (IV) every week in Cycle 1 (days 1, 8, 15, and 22) and day 1 of every 28-day cycle for Cycles 2 through 5.

Claire (Myoung-Jin) Lee, Medical doctor

The Drug Use Examination (DUE) is planned and designed for the safety evaluation of new indications after the approval of a new drug in Korea.

This DUE is a non-interventional, observational and post-marketing surveillance, which will be conducted by collecting the safety information of REVLIMID® for new indications in routine clinical practice in Korea.

Six-Hundred (600) adult patients, who start with REVLIMID® treatment based on the approved local package insert (PI) of REVLIMID® during routine clinical practice in Korea and have indications noted below.

1. Patients with transfusion-dependent anemia due to IPSS low- or intermediate-1-risk Myelodysplastic Syndromes associated with a deletion 5q cytogenetic abnormality (del \[5q\] MDS)
2. Patients with mantle cell lymphoma who have received at least one prior therapy (rrMCL)
3. Previously treated follicular lymphoma (FL), in combination with rituximab (an anti-CD20 antibody)

A Non-interventional Study of REVLIMID® (Lenalidomide) Treatment of IPSS Low- or Intermediate-1-risk Myelodysplastic Syndromes Associated With a Deletion 5q or Refractory/Relapsed Mantle Cell Lymphoma in Korea

Post Marketing Surveillance on Safety Evaluation of REVLIMID® (Lenalidomide) Treatment of Myelodysplastic Syndromes Associated With a Deletion 5q or Mantle Cell Lymphoma in Korea

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Number of participants with adverse event

Effectiveness evaluation for IPSS low- or intermediate-1-risk del (5q) MDS is RBC transfusion-independence response rate for ≥ 56 days (8 weeks) in patients who receive at least 2 cycles of Revlimid

Effectiveness evaluation for refractory/relapsed Mantle Cell Lymphoma (rrMCL) is Overall Response Rate up to 6 cycles assessed by the investigators using the Cheson Criteria, 1999

Effectiveness evaluation for refractory/relapsed previously treated FL is Overall Response Rate up to 6 cycles assessed by the investigators per 2007 International Working Group criteria.

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

Doxorubicin

Liposomal doxorubicin

Chlorotrianisene

Liver Extracts

The control arm will be of the patients that have been treated historically in the centers with conventional TACE (that is Lipiodiol plus doxorubicin).

HCC patients will receive chemoembolization (TACE) using DC beads containing Doxorubicin. The objective is to give 2 vials of DC Bead (2ml per vial) loaded with 70-75mg of Doxorubicin per vial (Each vial contain 2ml of DC Bead, thus doxorubicin concentration will be of 35-37.5mg per ml of DC Beads)

DebDox TACE

Jin Wook Chung, MD

In unresectable hepatocellular carcinoma, TACE using Lipiodol/anti cancer agent emulsion is the standard treatment and reported as a significantly better treatment through randomized comparison study like Llovet, etc. than conservative treatment. Recently, doctors do transarterial chemoembolization with drug-eluting bead, and it is proved less side effect and better efficacy than conventional TACE using Lipiodol in Precision V study by Dr. Lammer, etc. But, it could not defined improved survival rate as expected. This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using drug eluting bead by comparing to conventional TACE using doxorubicin/Lipiodol emulsion for unresectable hepatocellular carcinoma.

Comparison Between Drug-Eluting Bead vs conventional TACE.

Drug-eluting bead group : TACE using DC bead loading Doxorubicin. Conventional TACE group : TACE using Doxorubicin/Lipiodol emulsion and gelatin sponge/PVA particle.

cTACE group was chosen by concurrent matched patients (age, sex, tumor stage, and Child-Pugh class are matched)

5.7 Technically considerable aspects of DC bead TACE group

1. Planned dose of doxorubicin. Each vial of DC Bead (2 ml of beads) should be loaded with 70-75 mg doxorubicin (loading dose, 35-37.5 mg doxorubicin / ml of beads).

   * Early-stage HCC. As a general rule, each single treatment should include a planned dose of up to 75 mg doxorubicin loaded into one vial of DC Bead.
   * Medium-sized (less than 8cm) / multinodular HCC. As a general rule, each single treatment should include a planned dose of up to 150 mg doxorubicin loaded into two vials of DC Bead.
   * In large tumors (more than 8cm), even if unilobar, the separate treatment including two sessions 2-4 weeks apart is recommended.
   * In bilobar tumors, both hepatic lobes should be treated in separate treatment sessions 2-4 weeks apart, in the absence of complications requiring a longer time interval between the two sessions. Obtaining confirmation that the liver enzymes did return to baseline before performing the second treatment session is recommended.
2. Choice of DC Bead size. Use of 100-300μm beads is recommended for a standard procedure. However, individual patient and tumor characteristics, particularly the identification of arterio-venous shunting, should be taken into account when the safety of the treatment and the choice of DC Bead size are determined.

   * In the case of significant arterio-portal or hepatic venous shunting, embolization of the shunt with gelfoam pledgets is recommended before proceeding with DEBDOX. Confirmation that the shunt is no longer present must be obtained before DEBDOX can safely be performed. But, this study excludes the patients with arterio-portal or hepatic venous shunts.
   * In large tumors, hepatic arterial flow does not reach 'near stasis' after injection of 2 vial of 100-300 μm DC beads. The recommendation is following: 2 vials of the 100-300 μm DC beads is best and then repeat 2 weeks later if the patient is doing well clinically.
3. DC Bead dilution. Mix loaded DC Bead with a non-ionic contrast medium. At least 5-10 ml of non-ionic contrast should be used per 1 ml of DC Bead (i.e., 10-20 ml are required to dilute one vial of DC Bead) prior to injection.
4. Catheter positioning. A superselective (i.e., segmental or subsegmental) approach should be used whenever possible by using a microcatheter. Use of 3D / MPR obtained from C-arm rotational angiography with a flat-panel detector system (cone-beam CT) is recommended, if available, to improve the accuracy in identifying tumor-feeding arteries. Such imaging allows for accurate targeting of the tumor. In addition, repeat cone beam CT should be performed after successful delivery of the DC Bead to confirm adequate targeting and saturation of the tumor(s).

   * Segmental / subsegmental approach. Place the microcatheter into the segmental / subsegmental vessel feeding the tumor as distally as possible - but avoiding wedging the catheter to avoid reflux along the catheter shaft. Flow within the artery must be preserved.
   * Lobar approach. Place the catheter as selectively as possible in the right or left hepatic artery. Pay attention to identifying the origin of the cystic artery as well as other arteries supplying flow to extra-hepatic organs such as the right gastric artery, para-esophageal or omental vessels among others. If identified, these vessels must be either embolized using coils or avoided by placing the catheter tip well beyond the origin of these vessels. In addition, forward flow into the desired vessel must be maintained as inadvertent administration of even a few DC Beads into these extra-hepatic vessels could have dire consequences.
5. Injection. The injection must be very slow. An injection rate of 1 ml of the contrast agent - DC Bead suspension per minute is recommended. Thus, it takes 10-20 minutes to infusion 1 vial of DC bead. Care should be taken to avoid sedimentation of the beads in the syringe by rotating the syringes or using a 3-way stopcock to gently suspend the beads in the solution.
6. Embolisation endpoint. Injection should be continued until "near stasis" is observed in the artery directly feeding the tumor (i.e., the contrast the contrast column should clear within 2-5 heart beats). At that point, injection should be stopped - regardless of the amount of beads that have been actually administered - to avoid reflux of embolic material. Once the embolisation endpoint has been achieved, no additional embolic material should be injected. If the "near stasis" endpoint is not obtained after injection of the scheduled volume of beads, no additional embolization should be performed. This patient is likely to benefit from a second course after imaging follow-up.
7. extrahepatic collateral vessels. In principle, DC bead is used for collateral arterial circulation (inferior phrenic artery, internal mammary artery, intercostal artery), but doctors can do bland embolization (PVC particle, gelatin sponge) based on their judgement.
8. Repeated treatment. In principle, treatment with the same method is repeated for every 2 - 3 months as tumor progression is observed. But, even if tumor progression is not observed, the treatment can be repeated for tumor repression. If there is no tumor left, contrast enhancement CT or MRI can be performed for every 2- 3 months as follow up.

5.8. Dose in study Dose of DC bead, anti cancer agent for TACE dose is decided by tumor size. So, this study just set up the maximum dose.

Drug-eluting bead group DC bead : 2 bottles DC bead absorbs 70-75mg per bottle. Doxorubicin loading to DC bead needs to be done 1.5 hours before using. The size of DC bead is 100-300 micrometer, and it can be used up to 2 bottles.

Drug-eluting Bead in Hepatocellular Carcinoma

Multicenter Registry of Chemoembolization Using Drug-eluting Bead in Patients With Unresectable Hepatocellular Carcinoma

Seoul National University Hospital

professor of radiology

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

There is no treatment allocation. Patients administered Piqray by prescription will be enrolled.

Piqray

Novartis Pharmaceuticals

This is a prospective, multicenter, open-label, non-comparative, non-interventional, observational study to assess te safety and effectiveness of Piqray in the real-world setting

The observation duration will be up to 24 weeks after enrollment, which is sufficient to provide adequate information about the safety and effectiveness of Piqray. If the subject does not return for a follow-up visit or stops taking Piqray for any reason, all data collected until the date of the last contact of the subject will be used. Patients will be followed up (safety follow up) for 30 days afetr either 24 weeks-treatment or early withdrawal.

A Post Marketing Surveillance on Piqray in Korea

A Post Marketing Surveillance on Piqray (Alpelisib) in Korea

Incidence of AEs, including SAEs and ADRs

Objective response rates (ORRs). ORR is defined as the proportion of treated patients who achieve a best overall response (BOR) of partial response (PR) or complete response (CR) according to the response evaluation criteria in solid tumors (RECIST) version 1.1.

Prescription dose of Piqray in combination with fulvestrant

Azacitidine

Antimetabolites

Enzyme Inhibitors

All Korean patients intended to be treated with Vidaza® according to the approved package insert

The recommended starting dose for the first treatment for all patients regardless of baseline hematology values is Vidaza® 75mg/m2 subcutaneous(SC) injection or intravenous (IV) infusion, daily for 7 days.

Vidaza®

The main purpose of VIDAZA® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean MDS patients treated with VIDAZA®(SC or IV) according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy information of VIDAZA® in clinical practice is collected and evaluated. This DUE is a prospective, multi-centre, observational, non-interventional, post-marketing surveillance. At least 600 patients' data that is eligible for safety assessment will be collected.

VIDAZA® DUE is to investigate frequency and change of Adverse Events(AEs)

/Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety \& efficacy of the drug. It is necessary to examine patients' demographics and baseline characteristics, medical history, status of VIDAZA treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.

Post Marketing Surveillance to Collect and Evaluate the Safety and Efficacy Information of Korean MDS Patients Treated With VIDAZA®, After Approval of Marketing Authorization for New Drug in Korea

VIDAZA® Drug Use Examination

An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

An SAE is any event that:

* is fatal or life threatening
* results in persistent or significant disability or or incapacity;
* requires or prolongs existing hospitalization;
* is a congenital anomaly/birth defect in the offspring of a patient who received medication;
* conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.

Number of patients with response (CR, PR, mCR) based on the International Working Group (IWG 2006) response criteria for Myelodysplastic Syndrome (MDS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females	NCT01101542	Infections, Pap...	Cervarix. Data collection	10 Years - 25 Years	GlaxoSmithKline
A Study to Collect and Evaluate the Safety and Efficacy Information of Korean Multiple Myeloma Patients Treated With REVLIMID®, After Approval of Marketing Authorization for New Drug in Korea	NCT02556905	Multiple Myelom...	REVLIMID® Dexamethasone	18 Years -	Celgene
A Non-interventional Study of REVLIMID® (Lenalidomide) Treatment of IPSS Low- or Intermediate-1-risk Myelodysplastic Syndromes Associated With a Deletion 5q or Refractory/Relapsed Mantle Cell Lymphoma in Korea	NCT04036448	Myelodysplastic... Lymphoma, Mantl... Lymphoma, Folli...	REVLIMID®	19 Years -	Celgene
Drug-eluting Bead in Hepatocellular Carcinoma	NCT01332669	Hepatocellular ...	DebDox TACE	20 Years -	Seoul National University Hospital
A Post Marketing Surveillance on Piqray in Korea	NCT05293470	Breast Cancer	Piqray	18 Years -	Novartis
A Post Marketing Surveillance on Piqray in Korea	NCT05293470	Breast Cancer	Piqray	18 Years -	Novartis
Post Marketing Surveillance to Collect and Evaluate the Safety and Efficacy Information of Korean MDS Patients Treated With VIDAZA®, After Approval of Marketing Authorization for New Drug in Korea	NCT02137629	Myelodysplastic...	Vidaza®	18 Years -	Celgene
Post Marketing Surveillance to Collect and Evaluate the Safety and Efficacy Information of Korean MDS Patients Treated With VIDAZA®, After Approval of Marketing Authorization for New Drug in Korea	NCT02137629	Myelodysplastic...	Vidaza®	18 Years -	Celgene
Drug-eluting Bead in Hepatocellular Carcinoma	NCT01332669	Hepatocellular ...	DebDox TACE	20 Years -	Seoul National University Hospital

Spots Global Cancer Trial Database for korea

Every month we try and update this database with for korea cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for korea

Every month we try and update this database with for korea cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for korea cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.