[Translation] Post-marketing study of yttrium [90Y] resin microspheres in the treatment of patients with unresectable colorectal liver metastases who have failed standard therapy

主要目的：在经标准治疗失败的不可手术切除的结直肠癌肝转移患者中，研究者采用RECIST v1.1标准评价钇[90Y]树脂微球治疗后的肝特异性客观缓解率（ORR）

[Translation]

Primary objective: To evaluate the liver-specific objective response rate (ORR) after yttrium [90Y] resin microsphere therapy using RECIST v1.1 criteria in patients with unresectable colorectal liver metastases who failed standard treatment.

Start Date30 Nov 2023

Sponsor / Collaborator

Sirtex Medical Pty Ltd.

[+2]

DRKS00032073

/ CompletedNot ApplicableIIT

Radioembolization with holmium-containing microspheres: Use of the Holmium Platform for the treatment of patients with hepatocellular carcinoma

Start Date10 Jun 2022

Sponsor / Collaborator-

NCT04736121

/ Active, not recruitingNot Applicable

A Prospective, Multicenter, Open-label Single Arm Study Evaluating the Safety & Efficacy of Selective Internal Radiation Therapy Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients

The objective of this pivotal study is to evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C.
SIR-Spheres consist of biocompatible resin microspheres containing yttrium-90 (Y-90), with a size between 20 and 60 microns in diameter. Y-90 is a high-energy pure beta-emitting isotope with no primary gamma emission.
SIR-Spheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1 and B2, maximal single lesion size of 8 cm, no macrovascular invasion, well-compensated liver function and good performance status. It is also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of Floxuridine (FUDR).

Start Date28 May 2021

Sponsor / Collaborator

Sirtex Medical Pty Ltd.

[+1]

100 Clinical Results associated with SIR-Spheres

100 Translational Medicine associated with SIR-Spheres

100 Patents (Medical) associated with SIR-Spheres

Literatures (Medical) associated with SIR-Spheres

01 Sep 2024·Health physics

Feasibility of Liver Transplantation after 90Y Radioembolization: Lessons from a Radiation Protection Incident

Article

Author: Lussey-Lepoutre, Charlotte ; Savier, Eric ; Allaire, Manon ; Roux, Charles ; Maisonobe, Jacques-Antoine ; Maksud, Philippe ; Soret, Marine ; Kas, Aurélie ; Payen, Stéphane

Abstract:

Radioembolization using 90Y is a growing procedure in nuclear medicine for treating hepatocellular carcinoma. Current guidelines suggest postponing liver transplantation or surgical resection for a period of 14 to 30 d after radioembolization to minimize surgeons’ exposure to ionizing radiation. In light of a radiation protection incident, we reevaluated the minimum delay required between radioembolization and subsequent liver transplantation. A patient with a hepatocellular carcinoma underwent a liver transplantation 44 h after undergoing radioembolization using 90Y (860 MBq SIR-Spheres). No specific radioprotection measures were followed during surgery and pathological analysis. We subsequently (1) evaluated the healthcare professionals' exposure to ionizing radiation by conducting dose rate measurements from removed liver tissue and (2) extrapolated the recommended interval to be observed between radioembolization and surgery/transplantation to ensure compliance with the radiation dose limits for worker safety. The surgeons involved in the transplantation procedure experienced the highest radiation exposure, with whole-body doses of 2.4 mSv and extremity doses of 24 mSv. The recommended delay between radioembolization and liver transplantation was 8 d when using SIR-Spheres and 15 d when injecting TheraSphere. This delay can be reduced further when considering the specific 90Y activity administered during radioembolization. This dosimetric study suggests the feasibility of shortening the delay for liver transplantation/surgery after radioembolization from the 8th or 15th day after using SIR-Spheres or TheraSphere, respectively. This delay can be decreased further when adjusted to the administrated activity while upholding radiation protection standards for healthcare professionals.

01 May 2024·European Journal of Nuclear Medicine and Molecular Imaging

MIDOS: a novel stochastic model towards a treatment planning system for microsphere dosimetry in liver tumors

Article

Author: Dawson, Robert J ; Wehrenberg-Klee, Eric ; Paganetti, Harald ; Bolch, Wesley E ; Bertolet, Alejandro ; Beekman, Chris ; Withrow, Julia D ; Huesa-Berral, Carlos

PURPOSE:

Transarterial radioembolization (TARE) procedures treat liver tumors by injecting radioactive microspheres into the hepatic artery. Currently, there is a critical need to optimize TARE towards a personalized dosimetry approach. To this aim, we present a novel microsphere dosimetry (MIDOS) stochastic model to estimate the activity delivered to the tumor(s), normal liver, and lung.

METHODS:

MIDOS incorporates adult male/female liver computational phantoms with the hepatic arterial, hepatic portal venous, and hepatic venous vascular trees. Tumors can be placed in both models at user discretion. The perfusion of microspheres follows cluster patterns, and a Markov chain approach was applied to microsphere navigation, with the terminal location of microspheres determined to be in either normal hepatic parenchyma, hepatic tumor, or lung. A tumor uptake model was implemented to determine if microspheres get lodged in the tumor, and a probability was included in determining the shunt of microspheres to the lung. A sensitivity analysis of the model parameters was performed, and radiation segmentectomy/lobectomy procedures were simulated over a wide range of activity perfused. Then, the impact of using different microspheres, i.e., SIR-Sphere®, TheraSphere®, and QuiremSphere®, on the tumor-to-normal ratio (TNR), lung shunt fraction (LSF), and mean absorbed dose was analyzed.

RESULTS:

Highly vascularized tumors translated into increased TNR. Treatment results (TNR and LSF) were significantly more variable for microspheres with high particle load. In our scenarios with 1.5 GBq perfusion, TNR was maximum for TheraSphere® at calibration time in segmentectomy/lobar technique, for SIR-Sphere® at 1-3 days post-calibration, and regarding QuiremSphere® at 3 days post-calibration.

CONCLUSION:

This novel approach is a decisive step towards developing a personalized dosimetry framework for TARE. MIDOS assists in making clinical decisions in TARE treatment planning by assessing various delivery parameters and simulating different tumor uptakes. MIDOS offers evaluation of treatment outcomes, such as TNR and LSF, and quantitative scenario-specific decisions.

01 Jul 2023·Cardiovascular and interventional radiology

Predictive Factors for Adverse Event Outcomes After Transarterial Radioembolization with Yttrium-90 Resin Microspheres in Europe: Results from the Prospective Observational CIRT Study.

Article

Author: Helmberger, Thomas ; Maleux, Geert ; Bilbao, José I ; Zeka, Bleranda ; Albrecht, Thomas ; Schaefer, Niklaus ; Kolligs, Frank ; Cianni, Roberto ; Pereira, Helena ; Munneke, Graham ; Bargellini, Irene ; de Jong, Niels ; Arnold, Dirk ; Sangro, Bruno ; Peynircioglu, Bora

BACKGROUND:

Using data collected in the prospective observational study CIRSE Registry for SIR-Spheres Therapy, the present study aimed at identifying predictors of adverse events (AEs) following transarterial radioembolization (TARE) with Yttrium-90 resin microspheres for liver tumours.

METHODS:

We analysed 1027 patients enrolled between January 2015 and December 2017 and followed up for 24 months. Four hundred and twenty-two patients with hepatocellular carcinoma (HCC), 120 with intrahepatic carcinoma (ICC), 237 with colorectal liver metastases and 248 with liver metastases from other primaries were included. Prognostic factors were calculated with a univariable analysis by using the overall AEs burden score (AEBS).

RESULTS:

All-cause AEs were reported in 401/1027 (39.1%) patients, with AEs associated with TARE, such as abdominal pain (16.6%), fatigue (17%), and nausea (11.7%) reported most frequently. Grade 3 or higher AEs were reported in 92/1027 (9%) patients. Reports on grade ≥ 3 gastrointestinal ulcerations (0.4%), gastritis (0.3%), radiation cholecystitis (0.2%) or radioembolization-induced liver disease (0.5%) were uncommon. Univariable analysis showed that in HCC, AEBS increased for Eastern Cooperative Oncology Group (ECOG) 0 (p = 0.0045), 1 tumour nodule (0.0081), > 1 TARE treatment (p = 0.0224), no prophylactic embolization (p = 0.0211), partition model dosimetry (p = 0.0007) and unilobar treatment target (0.0032). For ICC, > 1 TARE treatment was associated with an increase in AEBS (p = 0.0224), and for colorectal liver metastases, ECOG 0 (p = 0.0188), > 2 prior systemic treatments (p = 0.0127), and 1 tumour nodule (p = 0.0155) were associated with an increased AEBS.

CONCLUSION:

Our study confirms that TARE is a safe treatment with low toxicity and a minimal impact on quality of life.

News (Medical) associated with SIR-Spheres

07 Jul 2025

·www.prnewswire.com

Sirtex Medical's SIR-Spheres® Y-90 Resin Microspheres Receive FDA Approval for the Treatment of Unresectable Hepatocellular Carcinoma

Expanded indication makes SIR-Spheres® the first and only radioembolization therapy in the U.S. approved to treat both unresectable hepatocellular carcinoma and metastatic colorectal cancer WOBURN, Mass., July 7, 2025 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of interventional oncology solutions, today announced that the U.S. Food and Drug Administration (FDA) approved SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the United States. With this approval, SIR-Spheres® is the only radioembolization therapy approved for the treatment of both metastatic colorectal cancer (mCRC) of the liver and HCC in the U.S. HCC is the most common form of liver cancer in adults in the U.S., according to the American Cancer Society. Radioembolization–commonly referred to as selective internal radiation therapy (SIRT)–with SIR-Spheres® uses personalized dosimetry to deliver the optimal dose of radiation directly to tumors in patients with HCC. This approval gives clinicians expanded flexibility in selecting a liver-directed therapy that aligns with patient-specific needs and treatment goals. "The expanded indication makes SIR-Spheres® the only Y-90 treatment approved in the U.S. for both HCC and mCRC," said Matt Schmidt, CEO of Sirtex. "This milestone reflects our ongoing commitment to delivering flexible, personalized therapies—with multiple dose options available daily—that empowers physicians to treat patients when and where it works best." This regulatory milestone is supported by results from the DOORwaY90 study, a prospective, multicenter, open-label clinical trial evaluating the safety and efficacy of SIR-Spheres® in treating HCC. The study enrolled 100 patients across 18 U.S. centers, with 65 patients included in the interim primary efficacy cohort. DOORwaY90 met its prespecified co-primary endpoints, demonstrating a best overall response rate (ORR) of 98.5% as assessed by independent central review. All evaluable patients demonstrated a response, indicating a 100% local tumor control rate. Additionally, the median duration of response (DoR) exceeded 300 days. These findings highlight SIR-Spheres® as a highly effective liver-directed therapy with a favorable safety profile. "This study moves the field of radioembolization forward with reproducible dosimetry outcomes and a strong safety profile linked to very positive clinical results," said Dr. Armeen Mahvash, Interventional Radiologist at MD Anderson Cancer Center and Co-Principal Investigator of the DOORwaY90 Study. "This will give multidisciplinary care teams the confidence to recommend SIR-Spheres® for HCC treatment." For more information and details on how to incorporate SIR-Spheres® into your practice, please contact Sirtex at [email protected]. About SIR-Spheres ® SIR-Spheres® Y-90 resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine). Caution: Federal (USA) law restricts this device for sale by or on the order of a physician. Consult the Instructions for Use ( ) for a complete listing of indications, contraindications, side effects, warnings and precautions. About Sirtex Sirtex Medical is a global healthcare company focused on advancing minimally invasive, liver-directed cancer and embolization therapies. With offices in the U.S., Australia, Europe, and Asia, Sirtex delivers innovative interventional oncology and embolization solutions to physicians and patients worldwide. The company's lead product, SIR-Spheres® Y-90 resin microspheres, is now the only FDA approved product in the United States indicated for both the treatment of hepatocellular carcinoma (HCC) and metastatic colorectal cancer (mCRC). For more information, visit . APM-US-010-06-25 SOURCE Sirtex Medical Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalRadiation Therapy

16 Sep 2024

·www.prnewswire.com

Sirtex Medical Announces Certification of SIR-Spheres® Y-90 Resin Microspheres According to Medical Device Regulation (EU) 2017/745 and European Launch of the Innovative SIROS™ Delivery System

Sirtex brings an innovative liver cancer treatment delivery system to Europe, enhancing options for physicians and their patients. WOBURN, Mass., Sept. 16, 2024 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of interventional treatment solutions, today announced that it has received certification according to Medical Device Regulation (EU) 2017/745 for SIR-Spheres® Y-90 resin microspheres and its delivery systems, paving the way for the European launch of the SIROS™ Delivery System. The EU MDR places greater emphasis on patient safety measures, risk management, post-market surveillance, and comprehensive data collection for medical devices seeking European market access. "Patient health and safety are always at the forefront of our work. That is why we are particularly proud to receive EU MDR certification for SIR-Spheres® Y-90 resin microspheres and its delivery systems, including SIROS™. This achievement underscores our commitment to delivering innovative products responsibly and ethically," said Matt Schmidt, CEO of Sirtex Medical Inc. "With the expansion of SIROS™ outside of the U.S., interventional radiologists in Europe now have an additional option to support patients battling metastatic colorectal cancer (mCRC) and unresectable hepatocellular carcinoma (HCC). This milestone reflects the outstanding efforts of our team, the rapid growth of our business, and the groundbreaking interventional oncology solutions we have developed." The SIROS™ Delivery System offers an intuitive, visual, and adaptable solution for physicians to administer SIR-Spheres® to liver cancer patients. Its easy-to-use design along with controlled administration provides physicians confidence in the Y-90 delivery. "As an interventional radiologist, I am excited about the future use of the SIROS™ Delivery System," shared Professor Thomas Helmberger, Head of Department of Radiology, Neuroradiology, and Minimal-Invasive Therapy at München Klinik Bogenhausen in Munich, Germany. "This device has an intuitive design and a precise control that will facilitate the administration of SIR-Spheres® Y-90 resin microspheres, and I am looking forward to incorporating it into my practice." About SIR-Spheres® in Europe SIR-Spheres® are medical devices used in selective internal radiation therapy (SIRT) and are indicated for the treatment of unresectable hepatocellular carcinoma (HCC) and unresectable metastatic liver tumors from primary colorectal cancer (mCRC) in patients refractory to or intolerant of chemotherapy. For a complete listing of indications, contraindications, side effects, warnings, and precautions, please consult the Instructions for Use at . About Sirtex Sirtex is a global healthcare company with offices in the U.S., Australia, Europe, and Asia, dedicated to improving patients' quality of life and longevity through innovative, minimally invasive cancer and embolization therapies. Sirtex's current leading product, SIR-Spheres® Y-90 resin microspheres, offers targeted radiation therapy for liver cancer. For more information, visit . SOURCE Sirtex Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Radiation Therapy

05 Aug 2024

·www.prnewswire.com

Sirtex Medical Launches SIR-Spheres® FLEXdose SELECT Delivery Program to Enable More Selective Y-90 Treatment Plans

Sirtex announces SIR-Spheres® portfolio expansion to include the FLEXdose SELECT 3mL vial configuration allowing for more patient-specific Y-90 selective treatment plans WOBURN, Mass., Aug. 5, 2024 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of interventional treatment solutions, announced today the launch of its SIR-Spheres® FLEXdose SELECT Delivery Program, an innovative, new way to offer precise Y-90 selective internal radiation therapy for the treatment of metastatic colorectal cancer. SIR-Spheres® FLEXdose SELECT Delivery Program offers unparalleled flexibility by enabling tailored, patient-specific dosing from a single 3mL delivery vial. This program also marks the availability of 3mL SIR-Spheres® vials, which contain a reduced volume of microspheres (approximately 27 million compared to 44 million in the current 5mL vials). With up to five days pre-calibration available every day of the week, the novel Y-90 delivery program offers a vial of SIR-Spheres® designed for more selective treatment targeting. "We're pleased to introduce this latest innovation in Y-90 radioembolization therapy to treat a broader spectrum of tumor burden," said Matt Schmidt, CEO of Sirtex Medical Limited. "The SIR-Spheres® FLEXdose SELECT Delivery Program reflects our continued focus on listening to the needs of patients and physicians by enabling access to personalized Y-90 resin doses and expedited patient treatments." "I have found the SIR-Spheres® FLEXdose Program to be extremely helpful in treating my patients on a timely basis," explained Ripal Gandhi, M.D., a member of the Miami Cardiac & Vascular Institute and Miami Cancer Institute and the course director for the Symposium on Clinical Interventional Oncology. "With this program, I can personalize the Y-90 treatment for each of my patients using a product that is available every day of the week. I applaud Sirtex for investing resources in SIR-Spheres® FLEXdose SELECT and providing more options for physicians to optimize treatment strategies for even more patients." The new 3mL SIR-Spheres® Y-90 resin microspheres vials are available for order at [email protected]. For more information and details on how to incorporate the SIR-Spheres® FLEXdose SELECT Delivery Program into your practice, please contact Sirtex at [email protected]. About SIR-Spheres SIR-Spheres® are a medical device used in selective internal radiation therapy). SIR-Spheres® are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine). Caution: Federal (USA) law restricts this device for sale by or on the order of a physician. Consult the Instructions for Use () for a complete listing of indications, contraindications, side effects, warnings and precautions. About Sirtex Sirtex is a global healthcare business with offices in the U.S., Australia, Europe and Asia, working to improve outcomes in people with cancer. Sirtex's current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. For more information, visit . SOURCE Sirtex Medical Inc.

Radiation Therapy

100 Deals associated with SIR-Spheres

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatocellular Carcinoma	Germany	Sirtex Medical Pty Ltd.	22 Mar 2022
Liver Cancer	Germany	Sirtex Medical Pty Ltd.	22 Mar 2022
Colorectal Cancer	United States	Sirtex Medical Pty Ltd.	03 May 2002
Liver metastases	United States	Sirtex Medical Pty Ltd.	03 May 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Liver, cancer of, non-resectable	Phase 1	China	Suzhou Medinuoyi Medical Technology Co., Ltd.	23 Jul 2025
Unresectable Hepatocellular Carcinoma	Clinical	United States	Sirtex Medical Pty Ltd.	28 May 2021

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04736121 (DOORwaY90, NEWS) Manual	Not Applicable	Unresectable Hepatocellular Carcinoma	-	SIR-Spheres®	hdaqtzkkaf(pvslxjclal) = btdmkluqiy jcspvwinkm (elkbttqsmg ) View more	Positive	07 Jul 2025
NCT03380130 (NASIR-HCC, Pubmed) Manual	Phase 2	Hepatocellular Carcinoma	42	Nivolumab+SIR-Spheres	bqbutsgise(efdppaynne) = jimesysoyw mdfuidxgpk (xqjsrftkoq ) View more	Positive	01 Nov 2022
NCT03380130 (NASIR-HCC, Biospace) Manual	Phase 2	Hepatocellular Carcinoma	-	Y-90 resin microspheres	plfewvkzer(ysfoeevycv) = vysbsilaow blxufjxxrf (liqjtfprtq ) View more	Positive	14 Sep 2020
NCT03380130 (NASIR-HCC, ILCA2020)	Phase 2	Hepatocellular Carcinoma \| Unresectable Hepatocellular Carcinoma \| Advanced Hepatocellular Carcinoma ... View more	42	SIRT + Nivolumab	wkpjwjzmyi(dxrwhwjnly) = bvmhmoeipc bmxzenykzw (ktjfypoiyq ) View more	Positive	13 Sep 2020
NCT02416466 (HITM-SIR, Pubmed \| Cancer Gene Ther) Manual	Phase 1	Liver metastases CEA Positive	4	Anti-CEA CAR-T+SIR-Spheres	njgkuguuxz(amajmkiuqq) = gmvaypqobl dlznbcfqik (ehdjtzyyjs ) View more	Positive	01 May 2020
NCT02195011 (CTgov)	Phase 2	Colorectal Liver Metastases	26	Regorafenib+SIR-Spheres (Cohort 1: Regorafenib/SIR-Spheres/Regorafenib)	oljdoerlsz = nznyuhmheo gqzdwdxztm (nvrvbkjqhl, dzdprucdsj - owefglhrea) View more	-	12 Jul 2018
NCT02195011 (CTgov)	Phase 2	Colorectal Liver Metastases	26	Regorafenib+SIR-Spheres (Cohort 2: SIR-Spheres/Regorafenib)	oljdoerlsz = jhkjshmchr gqzdwdxztm (nvrvbkjqhl, afqxnoxqiz - ctwcsgkwbl) View more	-	12 Jul 2018
NCT01482442 (SARAH, Pubmed \| Lancet Oncol) Manual	Phase 3	Locally Advanced Hepatocellular Carcinoma	459	sorafenib+yttrium-90 resin microspheres	peufuanyvg(dxxwgcggdo) = nlagurdjfc xfltwsdvig (mpjhdktypl, 6.7 - 9.9) View more	Positive	01 Dec 2017
NCT01482442 (SARAH, Pubmed \| Lancet Oncol) Manual	Phase 3	Locally Advanced Hepatocellular Carcinoma	459	sorafenib	peufuanyvg(dxxwgcggdo) = rjfwttdihm xfltwsdvig (mpjhdktypl, 8.7 - 11.4) View more	Positive	01 Dec 2017
ASTRO2013	Not Applicable	-	-	Yttrium-90 Coated Resin Microspheres (K-Ras wild type)	qzxwsnirpf(tqebontgag) = aolvxpsdsb ennlyvdtls (cjujjhcexj ) View more	-	01 Oct 2013
ASTRO2013	Not Applicable	-	-	Yttrium-90 Coated Resin Microspheres (K-Ras mutated)	qzxwsnirpf(tqebontgag) = tcoeshiugr ennlyvdtls (cjujjhcexj ) View more	-	01 Oct 2013
ASCO2008	Not Applicable	Liver metastases	34	Radioactive microspheres (Yttrium-90 resin microspheres)	zgtlvbtcgj(wmwscofvtl) = mild to severe vvbdrxqvbf (urdbxmvsct )	-	20 May 2008
ASTRO2005	Not Applicable	Liver metastases	-	Yttrium-90 Microspheres	urndbbdsfx(osrcjllwgm) = common and self limiting and generally included nausea, abdominal discomfort and fatigue mbpbhgwqtt (ydpqzgdxhj ) View more	-	01 Oct 2005

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