LIBERTYVILLE, IL - Pharma Logistics (www.pharmalogistics.com), a leader in the pharmaceutical compliance and reverse distribution industry, welcomes David A. Hargraves as its new Chief Executive Officer, effective today. After having led Pharma Logistics through its growth over its 27-year history, Michael Zaccaro, its Founder, President & CEO, steps into a new role as a Board Member.

David A. Hargraves joins Pharma Logistics with over 25 years of leadership experience and more than 18 years dedicated to healthcare supply chain management. Previously serving as the Senior Vice President of Supply Chain at Premier Inc., David has a proven track record of successfully navigating complex business landscapes and delivering results. Prior to Premier, David served as Vice President of Clinical Supply Chain at UPMC.

“Our industry is at a pivotal juncture, poised for growth but grappling with challenges that demand bold solutions,” said Zaccaro. “As the industry faces the imperative for more capacity and enhanced resiliency, it is abundantly clear that Pharma Logistics needs a leader who will continue to deliver value for its clients, and expand its service offering with innovative solutions. This is precisely what David brings to the table.”

“As we embark on this next phase of growth, I intend to carry forward Mike’s spirit of entrepreneurship, devotion to excellence, and dedication to delivering value to our customers while upholding the highest ethical and regulatory standards. Together, we embark on a journey of transformative change, navigating challenges, seizing on untapped opportunities, and delivering exceptional service with innovative solutions for our current and future customers,” said Hargraves.

Pharma Logistics is poised to embrace a future characterized by innovation and expansion while continuing to serve as the compliance experts customers can trust.

REDWOOD CITY, CA - Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS) today announced it has entered into an agreement to divest its CIMERLI® (ranibizumab-eqrn) ophthalmology franchise, inclusive of CIMERLI and its supporting commercial infrastructure, to Sandoz for upfront, all-cash consideration of $170 million plus an additional amount for CIMERLI product inventory and subject to customary working capital adjustments at the closing date. This divestiture includes Coherus’ CIMERLI biologics license application, ophthalmology sales and select field reimbursement teams, CIMERLI product inventory on hand, and access to proprietary commercial software. 

“Since entering the ophthalmology market in 2022, we have gained strong market share and created significant value in a non-core therapeutic area by leveraging our buy-and-bill commercial expertise. We believe it is prudent to now monetize these non-core assets to pay down debt, reduce interest costs, and take the opportunity to focus on our core therapeutic area, oncology,” said Denny Lanfear, Chairman and Chief Executive Officer of Coherus. “Additionally, this divestiture will allow us to reduce our headcount and overhead costs, enhancing our sustainable and growing oncology business.” 

Coherus’ oncology assets include the UDENYCA ® (pegfilgrastim-cbqv) franchise, with three FDA-approved presentations; LOQTORZI™ (toripalimabtpzi), an FDA-approved, next-generation PD-1 inhibitor; and an immuno-oncology pipeline of next-generation tumor microenvironment oncology drug candidates. 

Closing is anticipated in the first half of 2024, subject to certain closing conditions and approvals, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

BASEL, SWITZERLAND – Novartis today presented data from the Phase III NETTER-2 trial showing that Lutathera^® (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) plus long-acting release (LAR) octreotide reduced the risk of disease progression or death by 72% as first-line therapy in patients with somatostatin receptor-positive (SSTR+) well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) versus high-dose octreotide LAR alone¹. Data were presented at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium.

“These positive results for Lutathera are practice-changing and offer new first-line treatment data for patients who have a significant unmet need. This study confirms the clinical benefit of first-line radioligand therapy for newly diagnosed patients living with these types of advanced GEP-NETs,” said Dr. Simron Singh, Associate Professor of Medicine at the University of Toronto and cofounder of the Susan Leslie Clinic for Neuroendocrine Tumours at the Odette Cancer Centre, Sunnybrook Health Sciences Centre, Ontario, Canada. “These findings should instill confidence among physicians in using Lutathera as a first-line treatment for patients with this life-threatening type of cancer.”

“This is the first positive Phase III trial of a radioligand therapy in the first-line setting, and the overall efficacy and safety results are amongst the most clinically relevant observed to date in this kind of advanced cancer, addressing a significant unmet need for patients with newly diagnosed advanced GEP-NETs,” said Jeff Legos, Global Head of Oncology Development at Novartis. “The positive results are a significant advancement and further reaffirm our strategy to research and develop radioligand therapies in earlier lines of treatment or stages of disease to improve outcomes for patients.”

No new or unexpected safety findings were observed in the study and data are consistent with the already well-established safety profile of Lutathera¹. Most patients (88%) in the Lutathera arm received all four cycles of Lutathera treatment. The most common all-grade AEs (≥20%) for the Lutathera arm vs. control arm were nausea (27.2% vs 17.8%), diarrhea (25.9% vs 34.2%) and abdominal pain (17.7% vs 27.4%), and the most common grade ≥3 AE (>5%) was lymphocyte count decreased (5.4% vs 0%).

NETs are a type of cancer that originate in neuroendocrine cells throughout the body and are commonly considered slow-growing malignancies. However, some NETs are associated with rapid progression and poor prognosis and in many cases, diagnosis is delayed until patients have advanced disease^2-4. Even though NETs are a rare (orphan) disease, their incidence has increased over the past several decades^2-5 and there is a need for continued research into treatment options for newly diagnosed patients.

The NETTER-2 trial is ongoing for further evaluation of secondary endpoints including overall survival and long-term safety.

BOSTON, MA - Ikena Oncology, Inc. (Nasdaq: IKNA), a leading targeted oncology company, has provided a significant organizational update, unveiling key objectives for advancing the development of its lead targeted oncology assets, IK-930 and IK-595. The company also announced a strategic organizational streamlining aimed at reallocating resources from exploratory research and discovery towards ongoing targeted oncology clinical programs. This move is part of Ikena's commitment to maximizing impact and propelling advancements in patient-directed cancer treatments.

Mark Manfredi, Ph.D., Chief Executive Officer of Ikena, emphasized the company's laser focus on advancing IK-930 and IK-595 in the coming year to yield interpretable and clear data reads, ultimately building value for investors. The streamlining effort includes a reduction in the workforce by approximately 35%, to be implemented throughout the first quarter of 2024.

"We are grateful for the impact our discovery and research team has had, but the renewed focus on our lead assets, IK-930 and IK-595, underscores our dedication to delivering the full therapeutic potential of our clinical candidates that we believe could transform the lives of cancer patients," stated Dr. Manfredi.

IK-930, a TEAD1-Selective Hippo Pathway Inhibitor, is making progress with an optimized formulation being dosed in the clinic alongside the original formulation. The company has expanded targeted recruitment of mesothelioma and epithelioid hemangioendothelioma (EHE) patients, with a clinical data update planned for the second half of 2024.

IK-595, a MEK-RAF Molecular Glue, has successfully passed the safety evaluation window for the initial cohort dosed in December 2023. Ongoing enrollment of targeted RAS and RAF mutant cancer patients in dose escalation is taking place, exploring multiple dosing schedules. Backfill and expansion cohorts are also planned in multiple indications where IK-595 may have differentiated advantages.

The strategic decision to reallocate resources from the discovery organization to clinical programs has been driven by the significant progress of IK-930 and IK-595. This includes a reduction in the workforce to enhance operational efficiency. With approximately $175 million in cash and cash equivalents as of December 31, 2023 (unaudited), the company's runway is extended into the second half of 2026.

Ikena Oncology, with a focus on developing differentiated therapies targeting nodes of cancer growth, spread, and therapeutic resistance, aims to efficiently develop innovative drugs for patients in need. The company's commitment to advancing its lead programs while optimizing its organizational structure reflects its dedication to addressing critical challenges in cancer treatment.

PHILADELPHIA, PA –– Darshan Shawn Parekh, PharmD, MHA, FACHE, has been appointed Chief Executive Officer of Roxborough Memorial Hospital, succeeding Burton Piper, who moved back to Tennessee to be closer to his family.

Parekh brings more than 20 years of acute care hospital management experience to his new position. He has extensive experience in growing and expanding programs, services, and facilities. Most recently, he served as Vice President at Temple University Health System, where he was responsible for oversight and provision of all pharmaceutical services within the health system. Prior to that role, Parekh was Vice President and Chief Ancillary Officer for Prospect Medical Holdings, a for-profit health system in California. Earlier in his career, he held pharmacy leadership positions with Jefferson Health in Abington, PA; the Massachusetts State Office of Pharmacy Services in Tewksbury, MA; Robert Wood Johnson University Hospital in Rahway, NJ; and Merck Research Laboratories.

“We are thrilled to have Shawn join Roxborough Memorial Hospital as the next CEO and member of the Senior Leadership Team,” said Sonia Mehta, MD, Chief Executive Officer, Region II, Corporate Chief Medical Officer, and Chief Academic Officer, Prime Healthcare Services. “Shawn’s acumen and accomplishments in safety, clinical excellence, quality, and performance metrics in operations and designing strategies have resulted in better patient care and outcomes, while enabling growth consistent with an organization’s core mission.”

“I am delighted to be joining Roxborough Memorial Hospital. This is an outstanding opportunity to be part an organization with a strong commitment to medical excellence,” said Parekh. “I look forward to working collaboratively with our medical staff, employees, patients, and the community to improve lives and to build a healthier tomorrow.”

Parekh earned his Master of Healthcare Administration from Ohio University in Athens, OH, and a Doctor of Pharmacy from the University of the Sciences in Philadelphia. Throughout his career, he has served on numerous boards and committees, and he is also a Fellow of the American College of Healthcare Executives.

Roxborough Memorial Hospital is an award-winning 131-bed acute care and teaching community hospital, in Philadelphia. It is part of Prime Healthcare Services, headquartered in Ontario, California, one of the nation’s leading hospital systems that also operates Suburban Community Hospital in Norristown, PA and Lower Bucks Hospital in Bristol, PA.

Roxborough Memorial has consistently received a Healthgrades Patient Safety Excellence Award and the American Heart Association/American Stroke Association’s Stroke Silver Plus Quality Award. It has been home to the Roxborough School of Nursing since 1898, as well as respected academic programs and medical staff.

BOSTON, MA - Clearway Health, a specialty pharmacy accelerator partnering with hospitals and health systems, has pioneered a model to support hospitals in enabling access to novel gene therapy treatments. The model was used to execute and accelerate payor, legal and procurement processes for Children’s National Hospital in Washington, D.C., to treat their first pediatric patient with ZYNTEGLO^®, a one-time, potentially curative breakthrough gene therapy treatment for transfusion-dependent beta-thalassemia, a rare blood disorder requiring regular red blood cell transfusions.

“Novel gene therapies represent the advancement of emerging therapies addressing the possibility of untethering patients from a lifetime of burdensome, costly, chronic care with a single treatment. While very promising, the full clinical impact of these treatments is not yet clear, driving questions on coverage, cost efficiency and delivery,” said Shawn Francis, PharmD, director of specialty pharmacy at Clearway Health.

By 2030, 54 approved gene and cell therapies are expected in the FDA pipeline, making it essential for healthcare institutions to adequately prepare to deliver gene therapy.

Navigating a potentially multimillion-dollar drug therapy involves a multidisciplinary approach that can be extremely time intensive and costly for health systems, involving an understanding of payor dynamics, prior authorizations, geographic complexities, patient financial access, assessment of proper staff training, legal and risk management, orchestration of stakeholders  and determining a procurement pathway. Clearway Health’s innovative framework supports health systems in navigating these dynamics, as well as the various intricacies that make it possible to absorb the high costs of a one-time, lump sum payment while protecting the financial integrity of the institution.

“Many health systems are not set up to coordinate the procurement of a novel gene therapy. There are an incredible amount of steps and considerations involved in the process,” said Eric Manuel Balmir, BS, MS, PharmD, CIM, vice president of clinical ancillary services and chief pharmacy officer of Children’s National Hospital. “Clearway Health’s framework allowed us to quickly and efficiently address these concerns, positioning our hospital to provide the latest pharmaceutical advancement.”

FORT LAUDERDALE, FL - Broward Health Medical Center's pharmacy program recently earned URAC Specialty Pharmacy Accreditation. This significant accomplishment demonstrates the hospital's success in setting high standards for outpatient pharmacies.

"This accreditation reflects the tremendous dedication of the pharmacy team, which strives to provide outstanding service to our South Florida community," said Manny Linares, CEO of Broward Health Medical Center. “After three years of hard work, we are delighted to have achieved the accreditation.”

URAC is the independent leader in promoting healthcare quality by setting high standards for clinical practice, consumer protections, performance measurement, operations infrastructure, and risk management. Broward Health's flagship hospital has successfully demonstrated its commitment to quality care, enhanced processes, patient safety, and improved outcomes.

“We are incredibly proud to have achieved this accreditation,” said Dave Lacknauth, PharmD, executive director of pharmacy services at Broward Health. “We understand the importance of these specialty medications in our community and are committed to delivering quality standards of care.”

“Now more than ever, specialty pharmacies are an essential part of the patient care team and patient experience. URAC congratulates Broward Health Medical Center on its achievement of Specialty Pharmacy Accreditation. This achievement demonstrates excellence in pharmacy operations, product handling, patient education, and patient management. When an organization achieves URAC accreditation, it demonstrates a commitment to improving the quality of care, which is important to patients, providers and payers,” said URAC’s President and CEO Shawn Griffin, M.D.

DAVOS, Switzerland - The world faces an emergency in women’s health even as the COVID-19 pandemic wanes, according to one of the largest annual updates on women’s well-being — the Hologic Global Women’s Health Index.

Women’s health innovation company Hologic, Inc. (Nasdaq: HOLX) partners with Gallup to create the Index, which in its third year shows that billions of women are not getting tested for potentially life-threatening conditions. The Index also shows that more women are sad, angry and worried now than at the height of the pandemic. Many young women don’t feel safe walking alone in their communities at night, and nearly 1 billion women spend a lot of their day in physical pain.

This year’s Index will be released today at the World Economic Forum in Davos, Switzerland. The launch event was convened by Goals House, a community that comes together at significant global moments throughout the year to drive progress toward the United Nations (UN) Sustainable Development Goals (SDGs).

The Index fills a critical gap in knowledge about the health, safety and well-being of women worldwide. Based on interviews with more than 147,000 women and men in 143 countries and territories, it represents the voices of 97% of the world’s women and girls aged 15 and older.

“The new Index findings make it exceedingly evident that, as countries emerge from the COVID-19 pandemic, women’s health remains in a state of emergency,” said Stephen P. MacMillan, Chairman, President and CEO of Hologic. “It’s time for world leaders to take a bolder stand for women and girls. Investing in women’s health not only benefits individual women, but also their families, communities and economies.”

Key findings from this year’s Index:

• Testing for major health conditions remains low. Most women didn’t receive key tests in the past 12 months, meaning that billions of women went untested for potentially life-threatening conditions:
  • Only 36% were tested for high blood pressure — a major risk factor for heart disease and stroke.
  • 19% were tested for diabetes, a leading cause of death for women.
  • 11% were tested for any type of cancer.
  • 10% were tested for a sexually transmitted disease or infection (STD/STI) — leaving nearly 2 billion women of reproductive age at risk of infertility, increased maternal and fetal mortality, and deadly diseases.
• Emotional health is worsening: More women say they are sad, angry and worried now than three years ago. About 4 in 10 women experienced worry and stress during a lot of the previous day, and women are more likely than men to report feeling these emotions. For example, women are 20% more likely than men to say they experience sadness daily.
• Other striking findings:
  • Physical pain is a significant problem. Nearly 1 billion women worldwide spent a lot of the previous day in physical pain.
  • Housing challenges continue. The percentage of women struggling to afford shelter has increased by more than half in the last decade.
  • Young women don’t feel safe. Many women, including more than 4 in 10 young women aged 15 to 24, do not feel safe walking alone at night.

Based on survey responses, the Index assigns a women’s health score to each country or territory. Taiwan led the world for the third consecutive year, scoring 72 out of a possible 100. Other top scores went to Kuwait (68), Austria (67) and Germany (67). The lowest scores went to the Democratic Republic of Congo (36), Sierra Leone (34) and Afghanistan (26).

The United States fell seven places from its ranking in the second year of the survey to number 30, on par with Kazakhstan. The United Kingdom and France both scored 60, a few points above the global average.

“The Index serves as a wake-up call that improving women’s health needs to be a top priority. If we follow the roadmap set out in this Index, we can meaningfully improve the health and well-being of women for generations to come,” said MacMillan.

This year’s Index report includes country spotlights, including case studies on what is working well. South Korea is a consistent leader in cancer testing, and after recent prioritization, Costa Rica is among the top countries for blood pressure testing.

To see the full Index and related resources, visit WomensHealthIndex.com.

RAHWAY, NJ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. The approval is based on data from the Phase 3 KEYNOTE-A18 trial, in which KEYTRUDA plus CRT demonstrated an improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 41% (HR=0.59 [95% CI, 0.43-0.82]) compared to placebo plus CRT in patients with FIGO 2014 Stage III-IVA disease. Median PFS was not reached in either group. This approval marks the third indication for KEYTRUDA in cervical cancer and the 39^th indication for KEYTRUDA in the U.S.

“Today’s approval of KEYTRUDA plus chemoradiotherapy is welcome news and gives patients with newly diagnosed FIGO 2014 Stage III-IVA cervical cancer, for the first time ever, the option of an anti-PD-1-based regimen to treat their cancer,” said Dr. Bradley Monk, oncologist and professor of obstetrics and gynecology at University of Arizona’s College of Medicine and Creighton University School of Medicine. “This KEYTRUDA-based regimen offers a new treatment option for these patients, so today’s approval has important implications for the way we treat them moving forward.”

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.

“Building on the established role of KEYTRUDA in advanced cervical cancer, KEYTRUDA plus chemoradiotherapy is now the first anti-PD-1-based regimen approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer regardless of PD-L1 expression,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “This approval provides newly diagnosed patients with an anti-PD-1-based treatment option that has the potential to reduce the risk of disease progression or death compared to chemoradiotherapy alone.”

In the U.S., KEYTRUDA has two additional approved indications in cervical cancer: in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test; and as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Study design and additional data supporting the approval

KEYNOTE-A18, also known as ENGOT-cx11/GOG-3047, is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT04221945) sponsored by Merck and conducted in collaboration with the European Network for Gynaecological Oncological Trial (ENGOT) groups and the GOG Foundation, Inc. (GOG) investigating KEYTRUDA in combination with CRT (cisplatin and external beam radiotherapy [EBRT] followed by brachytherapy [BT]). The trial enrolled 1,060 patients with cervical cancer who had not previously received any definitive surgery, radiation, or systemic therapy for cervical cancer. There were 596 patients with FIGO 2014 Stage III-IVA cervical cancer (tumor involvement of the lower vagina with or without extension onto pelvic sidewall or hydronephrosis/non-functioning kidney or has spread to adjacent pelvic organs) with either node-positive or node-negative disease, and 462 patients with FIGO 2014 Stage IB2-IIB cervical cancer (tumor lesions >4 cm or clinically visible lesions that have spread beyond the uterus but have not extended onto the pelvic wall or to the lower third of vagina) with node-positive disease; two patients had FIGO 2014 Stage IVB disease. Patients were randomized (1:1) to receive either:

• KEYTRUDA (200 mg intravenously [IV]) every three weeks (Q3W) for five cycles concurrent with cisplatin (40 mg/m² IV) weekly for five cycles (an optional sixth infusion could be administered per local practice) and radiotherapy (EBRT followed by BT), followed by KEYTRUDA (400 mg IV) every six weeks (Q6W) for 15 cycles;
• Placebo IV Q3W for five cycles concurrent with cisplatin (40 mg/m² IV) weekly for five cycles (an optional sixth infusion could be administered per local practice) and radiotherapy (EBRT followed by BT), followed by placebo IV Q6W for 15 cycles.

Treatment continued until RECIST v.1.1-defined progression of disease as determined by investigator or unacceptable toxicity. Assessment of tumor status was performed every 12 weeks from completion of CRT for the first two years, followed by every 24 weeks in year three, and then annually. The major efficacy outcome measures were PFS as assessed by investigator according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ, or histopathologic confirmation, and overall survival (OS).

The trial demonstrated a statistically significant improvement in PFS in the overall population. In an exploratory subgroup analysis for the 462 patients (44%) with FIGO 2014 Stage IB2-IIB disease, the PFS HR estimate was 0.91 (95% CI, 0.63-1.31), indicating that the PFS improvement in the overall population was primarily attributed to the results seen in the subgroup of patients with FIGO 2014 Stage III-IVA disease. Overall survival data were not mature at the time of PFS analysis, with 10% deaths in the overall population.

In the exploratory subgroup analysis of 596 patients with FIGO 2014 Stage III-IVA disease, 61 patients (21%) in the KEYTRUDA plus CRT arm (n=293) experienced a PFS event versus 94 patients (31%) in the placebo plus CRT arm (n=303). Median PFS was not reached in either arm. The 12-month PFS rate was 81% (95% CI, 75-85) for KEYTRUDA plus CRT versus 70% (95% CI, 64-76) for placebo plus CRT.

The median duration of exposure to KEYTRUDA was 12.1 months (range, 1 day to 27 months). Fatal adverse reactions occurred in 1.4% of 292 patients receiving KEYTRUDA in combination with chemoradiotherapy, including one case each (0.3%) of large intestinal perforation, urosepsis, sepsis, and vaginal hemorrhage. Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with CRT. Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with CRT. Serious adverse reactions occurring in ≥1% of patients included urinary tract infection (2.7%), urosepsis (1.4%), and sepsis (1%). KEYTRUDA was discontinued for adverse reactions in 7% of patients. The most common adverse reaction (≥1%) resulting in permanent discontinuation was diarrhea (1%). Adverse reactions leading to interruption of KEYTRUDA occurred in 43% of patients; the most common adverse reactions leading to interruption of KEYTRUDA (≥2%) were anemia (8%), COVID-19 (6%), SARS-CoV-2 test positive (3.1%), decreased neutrophil count (2.7%), diarrhea (2.7%), urinary tract infection (2.7%), and increased alanine aminotransferase (2.4%). The most common adverse reactions (≥10%) among patients receiving KEYTRUDA were nausea (56%), diarrhea (50%), vomiting (33%), urinary tract infection (32%), fatigue (26%), hypothyroidism (20%), constipation (18%), decreased appetite and weight loss (17% each), abdominal pain and pyrexia (12% each), hyperthyroidism, dysuria and rash (11% each), and pelvic pain (10%).