A Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Participants With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Carcinoma (SKYSCRAPER-08)

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Patients With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

The purpose of this study is to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin (PC) compared with atezolizumab matching placebo plus tiragolumab matching placebo plus PC as first-line treatment in participants with unresectable locally advanced, unresectable recurrent, or metastatic esophageal carcinoma (EC). Participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during induction phase:

Arm A: Atezolizumab plus Tiragolumab and PC Arm B: Atezolizumab placebo plus Tiragolumab placebo and PC Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab matching placebo plus tiragolumab matching placebo (Arm B).

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: Atezolizumab; Drug: Tiragolumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: Atezolizumab Matching Placebo; Drug: Tiragolumab Matching Placebo

• Study Type: Interventional
• Enrollment (Actual): 461
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui, China, 230001
    • Anhui Provincial Hospital
  • Anyang, China, 455000
    • Anyang Tumor Hosptial
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Beijing, China
    • Beijing Luhe Hospital Capital Medical University
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changchun, China, 132013
    • Jilin Cancer Hospital
  • Changsha, China, 410013
    • Hunan Cancer Hospital
  • Chengde, China, 067020
    • Affiliated Hospital of Chengde Medical University
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Chengdu, China, 610041
    • Sichuan Provincial Cancer Hospital
  • Chongqing, China, 404000
    • Chongqing Sanxia Central Hospital
  • Foshan, China, 510000
    • The First People's Hospital of Foshan
  • Fuzhou, China, 350014
    • Fujian Cancer Hospital
  • Fuzhou, China
    • Fujian Provincial Hospital
  • Guangdong Province Guangzhou City, China, 510515
    • Southern Medical University Nanfang Hospital
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Harbin, China, 150081
    • Harbin Medical University Cancer Hospital
  • Hefei, China, 230601
    • The Second Affiliated Hospital of Anhui Medical University
  • Hefei, China, 12345
    • Anhui Province Cancer Hospital
  • Huai'an, China
    • Huai'an First People's Hospital
  • Huai'an, China
    • The Second People's Hospital of Huai'an
  • Jining, China
    • Affiliated Hopsital of Jining Medical University
  • Lanzhou, China, 730000
    • Gansu Province People Hospital
  • Lianyungang, China, 222002
    • The First People's Hospital of Lian Yun Gang
  • Linyi, China, 276034
    • Linyishi Cancer Hospital
  • Luoyang, China, 471003
    • The First Affiliated Hospital to Henan University of Science and Technology
  • Nanjing, China, 211100
    • Jiangsu Cancer Hospital
  • Nanjing, China, 210029
    • Jiangsu Province Hospital of Chinese Medicine
  • Nantong, China, 226361
    • Nan Tong Tumor Hospital
  • Shanghai, China, 200000
    • Shanghai Chest Hospital
  • Shanghai, China, 200032
    • ZhongShan Hospital FuDan University
  • Shanghai, China, 200120
    • Fudan University Shanghai Cancer Center
  • Shantou, China, 515041
    • Cancer Hospital of Shantou University Medical College
  • Shengyang, China, 110042
    • Liaoning Provincial Cancer Hospital
  • Suining, China, 629000
    • Suining Central Hospital
  • Tianjin, China, 300060
    • Tianjin Cancer Hospital
  • Weifang, China
    • Weifang People's Hospital
  • Wuhan, China, 430079
    • Hubei Cancer Hospital
  • Wuhan, China, 430022
    • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
  • Wuxi, China, 214122
    • Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital )
  • Xi'an, China, 710061
    • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Xi'an, China, 710038
    • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
  • Xiamen, China, 361003
    • The First Affiliated Hospital of Xiamen University
  • Xiamen, China, 361004
    • Zhongshan Hospital Xiamen University
  • Xiangyang, China
    • Xiangyang Central Hospital
  • Xinxiang, China
    • The First Affiliated Hospital of Xinxiang Medical University
  • Xuzhou, China
    • Xuzhou Central Hospital
  • Yangzhou, China, 225001
    • Northern Jangsu People's Hospital
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
  • Zhengzhou, China, 450052
    • the First Affiliated Hospital of Zhengzhou University
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Shatin, Hong Kong
    • Prince of Wales Hosp
• South Korea
  • Daegu, South Korea, 41404
    • Kyungpook National University Chilgok Hospital
  • Goyang-si, South Korea, 10408
    • National Cancer Center
  • Seongnam-si, South Korea, 13605
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
• Taiwan
  • Kaohisung, Taiwan
    • Chang Gung Medical Foundation - Kaohsiung
  • Tainan, Taiwan, 00704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 112201
    • Taipei Veterans General Hospital
  • Zhongzheng Dist., Taiwan, 10048
    • National Taiwan University Hospital
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital
  • Songkhla, Thailand, 90110
    • Songklanagarind Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Histologically confirmed EC
• Unresectable locally advanced, unresectable recurrent, or metastatic disease
• Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Adequate hematologic and end-organ function
• Female participants must be willing to avoid pregnancy and refrain from donating eggs during the treatment period and for 90 days after the final dose
• Male participants with partners of childbearing potential must commit to the use of two methods of contraception and must not donate sperm for the study duration and 90 days after the final dose

Key Exclusion Criteria:

• Palliative radiation treatment for EC within 4 weeks prior to initiation of study treatment
• Evidence of complete esophageal obstruction not amenable to treatment
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• Uncontrolled tumor-related pain, uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Active or history of autoimmune disease or immune deficiency or leptomeningeal disease
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
• Malignancies other than EC within 2 years prior to screening with a negligible risk of metastasis or death adequately treated with expected curative outcome
• Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
• Positive test result for human immunodeficiency virus (HIV)
• Active hepatitis B or hepatitis C
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
• Treatment with any investigational therapy prior to initiation of study treatment
• Poor peripheral venous access
• Prior allogeneic stem cell or solid organ transplantation
• Concurrent participation in another therapeutic clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atezolizumab + Tiragolumab + PC; Participants will receive atezolizumab and tiragolumab on Day 1 of each 21-day cycle during the study followed by paclitaxel and cisplatin on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the induction treatment phase.	Drug: Atezolizumab; Atezolizumab at a fixed dose of 1200 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.; Other Names: Tecentriq; Drug: Tiragolumab; Tiragolumab at a fixed dose of 600 mg administered by IV infusion every Q3W on Day 1 of each 21-day cycle.; Other Names: MTIG7192A; Drug: Paclitaxel; Paclitaxel 175 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles.; Drug: Cisplatin; Cisplatin 60-80 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles.
Placebo Comparator: Placebo + PC; Participants will receive atezolizumab matching placebo and tiragolumab matching placebo on Day 1 of each 21-day cycle during the study followed by paclitaxel and cisplatin on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the induction treatment phase.	Drug: Paclitaxel; Paclitaxel 175 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles.; Drug: Cisplatin; Cisplatin 60-80 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles.; Drug: Atezolizumab Matching Placebo; Atezolizumab matching placebo administered by IV infusion, Q3W on Day 1 of each 21-day cycle.; Drug: Tiragolumab Matching Placebo; Tiragolumab matching placebo administered by IV infusion, Q3W on Day 1 of each 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Independent Review Facility (IRF)-Assessed Progression-Free Survival (PFS)	PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).	From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months)
Overall Survival (OS)	OS was defined as the time from randomization to death from any cause.	From randomization to death from any cause (up to approximately 27 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator-Assessed PFS	PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).	From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months)
IRF-Assessed Confirmed Objective Response Rate (ORR)	IRF- assessed confirmed ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as determined by an IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR	From randomization up to approximately 19 months
Investigator-Assessed Confirmed ORR	Investigator-assessed confirmed ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR	From randomization up to approximately 19 months
IRF-Assessed Duration of Objective Response (DOR)	DOR was defined as the time from the first occurrence of a documented objective response (OR) to progressive disease (PD) or death from any cause (whichever occurred first) as determined by an IRF according to RECIST v1.1. OR=CR+PR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.	From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months)
Investigator-Assessed DOR	DOR was defined as the time from the first occurrence of a documented objective response (OR) to progressive disease (PD) or death from any cause (whichever occurred first) as determined by the investigator according to RECIST v1.1. OR=CR+PR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.	From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months)
Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning as Measured by EORTC QLQ-C30	Clinically meaningful changes in physical functioning as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30). EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. Physical functioning was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by >/=10 points.	From randomization until the first confirmed clinically meaningful deterioration (up to approximately 27 months)
TTCD in Participant-Reported Role Functioning as Measured by EORTC QLQ-C30	Clinically meaningful changes in role functioning as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. Functioning items were scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by >/=10 points.	From randomization until the first confirmed clinically meaningful deterioration (up to approximately 27 months)
TTCD in Participant-Reported Global Health Status (GHS)/Quality of Life (QoL) as Measured by EORTC QLQ-C30	Clinically meaningful changes in GHS/QoL as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. GHS and QoL items were scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better GHS/QoL. Participants were considered "Worsened" if their baseline score decreased by >/=10 points.	From randomization until the first confirmed clinically meaningful deterioration (up to approximately 27 months)
TTCD in Participant-Reported Dysphagia as Measured by EORTC Quality of Life-Esophageal Cancer, Module 18 Questionnaire (EORTC QLQ-OES18)	Clinically meaningful changes in dysphagia as measured by the EORTC QLQ-OES18. EORTC QLQ-OES18 is a modular supplement to the EORTC QLQ-C30 questionnaire for use in participants with esophageal cancer. EORTC QLQ-OES18 consisted of 4 multiple-item scale (dysphagia, eating, reflux, and pain) and 6 single items (trouble swallowing saliva, choked when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking) with a recall period of the previous week. Each symptom item was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher transformed scores (i.e. closer to 100) reflecting worse symptoms. Participants were considered "Worsened" if their baseline score increased by >/=10 points.	From randomization until the first confirmed clinically meaningful deterioration (up to approximately 35 months)
Percentage of Participants With Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.	Up to approximately 35 months
Minimum Serum Concentration (Cmin) of Tiragolumab	As indicated in the row titles of the table Cmin of Cycle 1 was measured predose at Cycle (C) 2 Day (D) 1. Cmin of Cycle 2 was measured predose at C3D1, etc.	Predose at on Day 1 of Cycles (cycle=21 days) 2, 3, 4, 8, 12, 16
Maximum Serum Concentration (Cmax) of Tiragolumab		Cycle 1 (cycle=21 days), Day 1: 30 minutes postdose
Cmin of Atezolizumab	As indicated in the row titles of the table Cmin of Cycle 1 was measured predose at Cycle (C) 2 Day (D) 1. Cmin of Cycle 2 was measured predose at C3D1, etc.	Predose at on Day 1 of Cycles (cycle=21 days) 2, 3, 4, 8, 12, 16
Cmax of Atezolizumab		Cycle 1 (cycle=21 days), Day 1: 30 minutes postdose
Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab	Participants were considered to be anti-drug antibody (ADA) positive if they were ADA negative or had missing data at Baseline but developed an ADA response following study drug exposure (i.e., treatment-induced ADA positive), or if they were ADA positive at baseline and the titer of one or more postbaseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (i.e., treatment-enhanced ADA positive); these ADA positive responses are summarized together (induced + enhanced) in the 'treatment-emergent ADA positive' category.	Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 35 months)
Number of Participants Positive for ADAs to Atezolizumab	Participants were considered to be anti-drug antibody (ADA) positive if they were ADA negative or had missing data at Baseline but developed an ADA response following study drug exposure (i.e., treatment-induced ADA positive), or if they were ADA positive at baseline and the titer of one or more postbaseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (i.e., treatment-enhanced ADA positive); these ADA positive responses are summarized together (induced + enhanced) in the 'treatment-emergent ADA positive' category.	Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 35 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• Sun JM, Chao Y, Kim SB, Rha SY, Evans TRJ, Strickland AH, Wainberg Z, Chau I, Pelles-Avraham S, Ajani J, Malhotra R, Liu Q, Li S, Cha E, Kalaitzidou M, Huang X, Allen S, Hsu CH. First-line tiragolumab plus atezolizumab and chemotherapy in patients with previously untreated, locally advanced unresectable or metastatic oesophageal cancer (MORPHEUS-EC): a randomised, open-label, phase 1b/2 trial. Lancet Oncol. 2026 Jan;27(1):90-102. doi: 10.1016/S1470-2045(25)00402-4.
• Hsu CH, Lu Z, Gao S, Wang J, Sun JM, Liu T, Fan Q, Cai J, Ge F, Li S, Zhang L, Cha E, Allen S, Shen L. Tiragolumab plus atezolizumab and chemotherapy as first-line treatment for patients with unresectable oesophageal squamous cell carcinoma (SKYSCRAPER-08): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2026 Jan;27(1):103-115. doi: 10.1016/S1470-2045(25)00401-2.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Actual): February 13, 2023
• Study Completion (Actual): August 28, 2025

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Taxoids; Cyclodecanes; Diterpenes; Platinum Compounds; Paclitaxel; Cisplatin; atezolizumab; Tiragolumab
• Other Study ID Numbers: YO42138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes