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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1256-9711 | Registry Identifier | ICTRP |
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This is a parallel group, Phase 3, 2-arm study for treatment. The purpose of this study is to evaluate dupilumab subcutaneous (SC) injections compared to placebo in Chinese adult participants with CRSwNP, on a background therapy with intranasal corticosteroids (budesonide nasal spray).
Study details include:
up to 40 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab | Experimental | Dupilumab every 2 weeks (Q2W) via SC injection |
|
| Placebo | Placebo Comparator | Placebo matching dupilumab Q2W via SC injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | solution for subcutaneous injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Nasal Polyps Score at Week 24 | The NPS was the sum of the right and left nostril scores and assessed by central video recordings of bilateral nasal endoscopy. For each nostril, NPS was graded based on polyp size which ranged from 0: no polyps, 1: small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2: polyps reaching below the lower border of the middle turbinate, 3: large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, 4: large polyps causing complete obstruction of the inferior nasal cavity. Total NPS was the sum of right and left nostril scores; ranged from 0 (no polyps) to 8 (large polyps). Higher scores indicated more severe disease. Baseline was defined as the last available value before randomization. | Baseline (Day 1) and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Nasal Congestion/Obstruction Score (NCS) at Week 24 | The NCS was a patient reported outcome to evaluate nasal congestion/obstruction, a major clinical symptom in chronic rhinosinusitis phenotype with nasal polyps. The NCS was assessed by the participant on a daily basis from visit 1 and throughout the study. It consisted of a 0 to 3 categorical scale, where 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms. Higher scores indicated more severity. The Week 24 analysis score was calculated as the average of all scores during the 4 weeks before Week 24. Baseline was defined as the average of the scores in the 7 days prior to randomization. |
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Inclusion Criteria:
Participant must be at least 18 years of age at the time of signing the informed consent
Participants with bilateral sino-nasal polyposis that despite prior treatment with SCS anytime within the past 2 years; and/or who have a medical contraindication/intolerance to SCS; and/or had prior surgery for NP at Visit 1 have:
An endoscopic bilateral NPS at Visit 1 of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) as per central assessment
Ongoing symptoms (for at least 8 weeks before Visit 1) of:
Note: Plan to enroll at least 85% (approximately 52) participants with CRSwNP meeting following criterion:
• Participants with peripheral blood eosinophil count ≥300/mm3
Exclusion Criteria:
Biologic therapy/systemic immunosuppressant/immunomodulator within 4 weeks before Visit 1 or 5 half-lives, whichever is longer.
Any investigational monoclonal antibody (mAb) within 5 half-lives or within 6 months before Visit 1 if the half-life is unknown.
Anti-immunoglobulin E therapy (omalizumab) within 4 months prior to Visit 1.
Positive (or indeterminate) hepatitis B surface antigen (HBsAg) or, Positive total Hepatitis B core antibody (HBc Ab) confirmed by positive hepatitis B virus (HBV) DNA or, Positive HCV Ab confirmed by positive hepatitis C Virus (HCV) RNA.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : 1560005 | Beijing | 100044 | China | |||
| Investigational Site Number : 1560001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42299713 | Derived | Xian M, Wang M, Zhao C, Wan L, Xu Y, Meng J, Xu R, Song X, Shi L, Yang Y, Jiang Y, Wu Y, Ling B, Li V, Fontenot AP, Robinson LR, Phadke NA, Wang C, Zhang L. Efficacy and Safety of Dupilumab in Chinese Adult Patients With Chronic Rhinosinusitis With Nasal Polyps: A Randomized, Placebo-Controlled, Phase III Trial. Allergy. 2026 Jun 16. doi: 10.1111/all.70414. Online ahead of print. |
| Label | URL |
|---|---|
| EFC17026 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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A total of 63 participants were randomized in a 1:1 ratio to receive either matching placebo or dupilumab. Randomization was stratified by screening blood eosinophil count (>=300 cells per cubic millimeter [/mm^3] or <300 cells/mm^3).
The study was conducted at 18 centers in China. A total of 151 participants were screened from 16 May 2023 to 27 February 2024, of which 88 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to dupilumab subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 up to 24 weeks. |
| FG001 | Dupilumab 300 mg q2w | Participants received dupilumab 300 milligrams (mg) SC injection q2w from Day 1 up to 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The randomized population included all participants with a treatment kit number allocated and recorded in the interactive response technology database, regardless of whether the treatment kit was used or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks. |
| BG001 | Dupilumab 300 mg q2w | Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Nasal Polyps Score at Week 24 | The NPS was the sum of the right and left nostril scores and assessed by central video recordings of bilateral nasal endoscopy. For each nostril, NPS was graded based on polyp size which ranged from 0: no polyps, 1: small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2: polyps reaching below the lower border of the middle turbinate, 3: large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, 4: large polyps causing complete obstruction of the inferior nasal cavity. Total NPS was the sum of right and left nostril scores; ranged from 0 (no polyps) to 8 (large polyps). Higher scores indicated more severe disease. Baseline was defined as the last available value before randomization. | The intent-to-treat (ITT) population included all randomized participants analyzed according to the treatment group allocated by randomization, regardless of whether the treatment kit was used or not. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and Week 24 |
|
AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Helicobacter Gastritis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 ext 6# | Contact-US@sanofi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 14, 2022 | Sep 5, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2024 | Sep 5, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
solution for subcutaneous injection |
|
| Budesonide | Drug | nasal spray (suspension) |
|
| Baseline (Day -7 to Day -1) and Week 24 |
| Change From Baseline in Total Symptoms Score (TSS) at Week 24 | The TSS was a reflective score of the worst symptom severity over the past 24 hours by the participant. It was assessed by the participant on a daily basis from visit 1 and throughout the study. It consisted of the sum of the following rhinosinusitis symptom questions: nasal congestion, decreased/loss of sense of smell, rhinorrhea (average of anterior/posterior nasal discharge); each assessed on 0 to 3 categorical scale, where 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms. The TSS was a composite score by summing the above symptom scores and ranged from 0 (no symptoms) to 9 (severe symptoms). Higher scores indicated greater overall symptom severity. The Week 24 analysis score was calculated as the average of all scores during the 4 weeks before Week 24. Baseline was defined as the average of the scores in the 7 days prior to randomization. | Baseline (Day -7 to Day -1) and Week 24 |
| Change From Baseline in the Severity of Decreased/Loss of Smell at Week 24 | The decreased/loss of sense of smell severity was a reflective score of the worst symptom severity over the past 24 hours. It was assessed by the participant on a daily basis from visit 1 and throughout the study, using an e-diary. It consisted of a 0 to 3 categorical scale, where 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms. Higher scores indicated more severe symptoms. The Week 24 analysis score was calculated as the average of all scores during the 4 weeks before Week 24. Baseline was defined as the average of the scores in the 7 days prior to randomization. | Baseline (Day -7 to Day -1) and Week 24 |
| Change From Baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22) at Week 24 | The SNOT-22 was a validated 22-items questionnaire to assess the impact of chronic rhinosinusitis on health-related quality of life (HRQoL) with a recall period of 2 weeks. There were 5 domains that could be described within SNOT-22, including nasal, ear, sleep, general and practical, and emotional; each domain was scored on a 5-category scale which ranged from 0: no problem to 5: problem as bad as it can be. The total score was the sum of response to each of the 22 questions and ranged from 0 (no disease) to 110 (worst disease), higher scores indicated worse HRQoL. Baseline was defined as the last available value before randomization. | Baseline (Day 1) and Week 24 |
| Percentage of Participants Who Received Systemic Corticosteroid (SCS) or Underwent Nasal Polyposis (NP) Surgery During the Study Treatment | SCS for rescue treatment of nasal polyps or for another reason were prescribed to the participant by the site. For participants who had a surgery or had a scheduled date for surgery for NP, the reason (worsening signs and/or symptoms during the study), the expected or actual surgery date, the type and outcome of surgery was recorded in a specific e-case report form page. Percentage of participants who received SCS or underwent NP surgery during the study treatment are presented. | From randomization (Day 1) up to last dose of study treatment + 14 days, a maximum of 168 days |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events Leading to Treatment Discontinuation | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period. | From first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days |
| Beijing |
| 100730 |
| China |
| Investigational Site Number : 1560010 | Chengdu | 610041 | China |
| Investigational Site Number : 1560014 | Chongqing | 400016 | China |
| Investigational Site Number : 1560022 | Fuzhou | 350005 | China |
| Investigational Site Number : 1560012 | Guangzhou | 510163 | China |
| Investigational Site Number : 1560011 | Guangzhou | China |
| Investigational Site Number : 1560004 | Hangzhou | 310003 | China |
| Investigational Site Number : 1560006 | Hefei | 230001 | China |
| Investigational Site Number : 1560016 | Jinan | 250102 | China |
| Investigational Site Number : 1560025 | Jingzhou | 434020 | China |
| Investigational Site Number : 1560013 | Qingdao | China |
| Investigational Site Number : 1560017 | Shanghai | 200065 | China |
| Investigational Site Number : 1560018 | Taiyuan | 030001 | China |
| Investigational Site Number : 1560007 | Wuhan | 430022 | China |
| Investigational Site Number : 1560021 | Wuhan | 430060 | China |
| Investigational Site Number : 1560009 | Yantai | 264000 | China |
| Investigational Site Number : 1560020 | Zibo | 255036 | China |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Nasal Polyps Score (NPS) | NPS was sum of right and left nostril scores.For each nostril,NPS was graded based on polyp size,ranged from 0:no polyps,1:small polyps in middle meatus not reaching below inferior border of middle turbinate,2:polyps reaching below lower border of middle turbinate,3:large polyps reaching lower border of inferior turbinate or polyps medial to middle turbinate,4:large polyps causing complete obstruction of inferior nasal cavity.Total NPS:sum of right and left nostril scores;range:0(no polyps) to 8(large polyps).Higher scores:more severe disease.Baseline:last available value before randomization. | Mean | Standard Deviation | score on a scale |
|
| Description |
|---|
| OG000 | Placebo | Participants received placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks. |
| OG001 | Dupilumab 300 mg q2w | Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks. |
|
|
|
| Secondary | Change From Baseline in Nasal Congestion/Obstruction Score (NCS) at Week 24 | The NCS was a patient reported outcome to evaluate nasal congestion/obstruction, a major clinical symptom in chronic rhinosinusitis phenotype with nasal polyps. The NCS was assessed by the participant on a daily basis from visit 1 and throughout the study. It consisted of a 0 to 3 categorical scale, where 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms. Higher scores indicated more severity. The Week 24 analysis score was calculated as the average of all scores during the 4 weeks before Week 24. Baseline was defined as the average of the scores in the 7 days prior to randomization. | The ITT population included all randomized participants analyzed according to the treatment group allocated by randomization, regardless of whether the treatment kit was used or not. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day -7 to Day -1) and Week 24 |
|
|
|
|
| Secondary | Change From Baseline in Total Symptoms Score (TSS) at Week 24 | The TSS was a reflective score of the worst symptom severity over the past 24 hours by the participant. It was assessed by the participant on a daily basis from visit 1 and throughout the study. It consisted of the sum of the following rhinosinusitis symptom questions: nasal congestion, decreased/loss of sense of smell, rhinorrhea (average of anterior/posterior nasal discharge); each assessed on 0 to 3 categorical scale, where 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms. The TSS was a composite score by summing the above symptom scores and ranged from 0 (no symptoms) to 9 (severe symptoms). Higher scores indicated greater overall symptom severity. The Week 24 analysis score was calculated as the average of all scores during the 4 weeks before Week 24. Baseline was defined as the average of the scores in the 7 days prior to randomization. | The ITT population included all randomized participants analyzed according to the treatment group allocated by randomization, regardless of whether the treatment kit was used or not. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day -7 to Day -1) and Week 24 |
|
|
|
|
| Secondary | Change From Baseline in the Severity of Decreased/Loss of Smell at Week 24 | The decreased/loss of sense of smell severity was a reflective score of the worst symptom severity over the past 24 hours. It was assessed by the participant on a daily basis from visit 1 and throughout the study, using an e-diary. It consisted of a 0 to 3 categorical scale, where 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms. Higher scores indicated more severe symptoms. The Week 24 analysis score was calculated as the average of all scores during the 4 weeks before Week 24. Baseline was defined as the average of the scores in the 7 days prior to randomization. | The ITT population included all randomized participants analyzed according to the treatment group allocated by randomization, regardless of whether the treatment kit was used or not. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day -7 to Day -1) and Week 24 |
|
|
|
|
| Secondary | Change From Baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22) at Week 24 | The SNOT-22 was a validated 22-items questionnaire to assess the impact of chronic rhinosinusitis on health-related quality of life (HRQoL) with a recall period of 2 weeks. There were 5 domains that could be described within SNOT-22, including nasal, ear, sleep, general and practical, and emotional; each domain was scored on a 5-category scale which ranged from 0: no problem to 5: problem as bad as it can be. The total score was the sum of response to each of the 22 questions and ranged from 0 (no disease) to 110 (worst disease), higher scores indicated worse HRQoL. Baseline was defined as the last available value before randomization. | The ITT population included all randomized participants analyzed according to the treatment group allocated by randomization, regardless of whether the treatment kit was used or not. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and Week 24 |
|
|
|
|
| Secondary | Percentage of Participants Who Received Systemic Corticosteroid (SCS) or Underwent Nasal Polyposis (NP) Surgery During the Study Treatment | SCS for rescue treatment of nasal polyps or for another reason were prescribed to the participant by the site. For participants who had a surgery or had a scheduled date for surgery for NP, the reason (worsening signs and/or symptoms during the study), the expected or actual surgery date, the type and outcome of surgery was recorded in a specific e-case report form page. Percentage of participants who received SCS or underwent NP surgery during the study treatment are presented. | The ITT population included all randomized participants analyzed according to the treatment group allocated by randomization, regardless of whether the treatment kit was used or not. | Posted | Number | percentage of participants | From randomization (Day 1) up to last dose of study treatment + 14 days, a maximum of 168 days |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events Leading to Treatment Discontinuation | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period. | The safety population included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 11 |
| 32 |
| EG001 | Dupilumab 300 mg q2w | Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks. | 0 | 31 | 4 | 31 | 15 | 31 |
| Endometrial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDra 27.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
|
| Hepatic Steatosis | Hepatobiliary disorders | MedDra 27.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDra 27.1 | Systematic Assessment |
|
| Injection Site Reaction | General disorders | MedDra 27.1 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDra 27.1 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| TEAEs leading to treatment discontinuation |
|