Stop-reason hub
SAFETY clinical trial stops
Search 717 stopped clinical trials classified as safety, with source-linked records and failure-signal context.
This page groups real ClinicalTrials.gov-derived stopped trial records. The strongest added signal is the stop-reason classification: 717 of these records are likely biological failure signals, while the rest may reflect operational, strategic, regulatory, funding, enrollment, or unclear stop reasons.
Dominant stop reasons
- SAFETY
- 717
Notable sponsors
- Pfizer
- 23
- GlaxoSmithKline
- 18
- Novartis Pharmaceuticals
- 12
- Biogen
- 9
- Gilead Sciences
- 9
Related phases
- Phase II
- 276
- Phase I
- 257
- Phase III
- 124
- Phase IV
- 33
- Unknown
- 21
Crawlable stopped-trial records
Open ExploreShowing up to 100 representative records from this slice. Each link opens the trial detail page with source attribution and stop-reason context.
Phase II Pulmonary Arterial Hypertension trial by Keros Therapeutics, Inc.. Stop reason: SAFETY.
The study was voluntarily terminated early, following a safety review and observation of pericardial effusions.
Phase I Glioma, Malignant trial by Northwestern University. Stop reason: SAFETY.
Safety issues
Phase I Rectal Neoplasms trial by University of Iowa. Stop reason: SAFETY.
Toxicity in phase 1
Phase I Advanced Adenocarcinoma trial by University of California, Davis. Stop reason: SAFETY.
Drugs unavailable
Phase I Breast Cancer trial by M.D. Anderson Cancer Center. Stop reason: SAFETY.
Toxicity and Lack of Efficacy
Phase I Perinatal Arterial Ischemic Stroke trial by James Baumgartner, MD. Stop reason: SAFETY.
The FDA required a clinical hold for the IND which remained until it was determined that the study would be closed.
Phase I Breast Cancer trial by Filipa Lynce, MD. Stop reason: SAFETY.
Zentalis terminated contract due to concern for toxicity safety from previously reported serious adverse events. This study had been designed as a Phase I / Phase II study, but never reached Phase II.
Phase I Solid Tumors trial by Hoffmann-La Roche. Stop reason: SAFETY.
After risk/benefit analysis, there was a very low probability (4.4%) of meeting the prespecified gating criteria for the Objective Response Rate at the final analysis.
Phase I Endometrial Cancer trial by Genmab. Stop reason: SAFETY.
Genmab has decided to discontinue the clinical development of GEN1107 as the overall benefit-risk profile no longer supports continuation
Phase II Rheumatoid Arthritis trial by BeiGene. Stop reason: SAFETY.
Sponsor has concluded that patients are unlikely to derive sufficient benefit from treatment with BGB-45035 to support continuation of the clinical development program due to unfavored benefit/risk profile.
Phase II Diabetes Mellitus, Type 1 trial by Tolerion, Inc.. Stop reason: SAFETY.
The DSMB concluded that there was a low probability the study would meet it is primary endpoint as designed.
Phase IV Pain Control trial by Mayo Clinic. Stop reason: SAFETY.
Study participant had a related adverse event that prompted interim data analysis and additional study participants were not sought.
Phase II Acute Lymphoblastic Leukemia trial by Fred Hutchinson Cancer Center. Stop reason: SAFETY.
Study was terminated prior to enrolling protocol target accrual goal due to declining accrual and Data Safety Monitoring Board recommendations.
Phase II Traumatic Brain Injury trial by Christine Marx, MD. Stop reason: SAFETY.
FDA partial clinical hold.
Phase I Advanced Solid Tumor trial by Genmab. Stop reason: SAFETY.
Genmab has decided to terminate the GEN1286 program due to an unfavorable benefit-risk profile not supporting further development.
Phase II Angioedema, Hereditary, Types I and II trial by KalVista Pharmaceuticals, Ltd.. Stop reason: SAFETY.
Terminated by Sponsor due to adverse events reported
Phase III HIV Preexposure Prophylaxis trial by Merck Sharp & Dohme LLC. Stop reason: SAFETY.
Voluntarily terminated due to benefit/risk assessment.
Phase II Post-COVID-19 Syndrome trial by Charite University, Berlin, Germany. Stop reason: SAFETY.
Following a recommendation from the Data Safety Monitoring Board (DSMB).
Phase II Treatment Resistant Depression trial by Merck Sharp & Dohme LLC. Stop reason: SAFETY.
Voluntarily terminated due to benefit/risk assessment
Phase III Hypertension trial by Ablative Solutions, Inc.. Stop reason: SAFETY.
Study enrollment and treatment are temporarily suspended due to an FDA clinical hold. The sponsor is actively addressing the FDA's requests.
Phase III Thyroid Eye Disease trial by Immunovant Sciences GmbH. Stop reason: SAFETY.
The feeder studies (i.e., IMVT-1401-3201 and 3202) for study IMVT-1401-3203 failed to achieve their pre-defined primary efficacy outcomes. Accordingly, there was a change to the benefit-risk balance. No new safety findings were observed.
Phase I Extensive-stage Small-cell Lung Cancer trial by Sichuan University. Stop reason: SAFETY.
Inorder to avoid the serious adverse effect of Toripalimab combining with Tifcemalimab, considering as the protection of participants.
Phase I Type 2 Diabetes Mellitus trial by AstraZeneca. Stop reason: SAFETY.
Safety issue was identified in the Phase2b D7860C00006 study, evaluating AZD6793 in moderate to very severe COPD participants. D7860C00005 study is temporary halted to amend the design to reflect changes implemented in the ongoing D7860C00006 study
Phase I IDH1-mutant Cholangiocarcinoma trial by Servier Bio-Innovation LLC. Stop reason: SAFETY.
The sponsor decided to terminate the study during the safety lead-in phase.
Phase II Alcohol Use Disorder (AUD) trial by Tempero Bio, Inc.. Stop reason: SAFETY.
Study was terminated due to serious adverse event (SAE)
Phase I Graft Versus Host Disease trial by Hackensack Meridian Health. Stop reason: SAFETY.
Dose Limiting Toxicities
Phase II Lymphoma trial by Eric Jacobsen, MD. Stop reason: SAFETY.
Ipsen requested a temporary closure due to a safety concern.
Phase I Currently Only Enrolling Glioblastoma Patients at First Recurrence trial by City of Hope Medical Center. Stop reason: SAFETY.
Safety issues
Phase II Atopic Dermatitis trial by RAPT Therapeutics, Inc.. Stop reason: SAFETY.
Study on clinical hold by FDA
Phase II Asthma trial by RAPT Therapeutics, Inc.. Stop reason: SAFETY.
Study on clinical hold by FDA
Phase II Heart Failure trial by Pfizer. Stop reason: SAFETY.
Following a prespecified interim analysis, and in consultation with the independent Data Monitoring Committee, the Sponsor terminated the study
Phase II Solid Tumor trial by Prisma Health-Upstate. Stop reason: SAFETY.
Ipsen has discontinued all active tazemetostat clinical trials and expanded access programs due to the emergence of a clinically unfavorable benefit risk profile for tazemetostat in combination with lenalidomide and rituximab.
Phase III Cancer trial by University Hospital, Strasbourg, France. Stop reason: SAFETY.
Numerous premature study discontinuations due to adverse events
Phase III Sickle Cell Disease trial by Pfizer. Stop reason: SAFETY.
Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.
Phase I Metastatic Castration-resistant Prostate Cancer trial by Regeneron Pharmaceuticals. Stop reason: SAFETY.
Due to a Dose Limiting Toxicity.
Phase III Adolescent Lupus Nephritis trial by Aurinia Pharmaceuticals Inc.. Stop reason: SAFETY.
DSMB recommendation
Phase III Adolescent Lupus Nephritis trial by Aurinia Pharmaceuticals Inc.. Stop reason: SAFETY.
DSMB recommendation
Phase I Soft Tissue Sarcoma trial by Wake Forest University Health Sciences. Stop reason: SAFETY.
Terminated due DLTs
Phase I PIK3CA-Related Overgrowth trial by Centre Hospitalier Universitaire Dijon. Stop reason: SAFETY.
In accordance with the protocol, following the occurrence of two SUSARs, the TOTEM trial was stopped early for safety reasons.
Phase III HIV-I trial by Merck Sharp & Dohme LLC. Stop reason: SAFETY.
Voluntarily terminated due to benefit/risk assessment
Phase I Advanced Solid Tumor trial by Sonnet BioTherapeutics. Stop reason: SAFETY.
Failed to meet efficacy endpoint criteria, despite lack of safety concerns
Phase I Acute Myeloid Leukemia trial by National Cancer Institute (NCI). Stop reason: SAFETY.
Other - Adverse Events
Phase I Malignant Solid Tumor trial by Genmab. Stop reason: SAFETY.
The sponsor has made the decision to terminate further development of GEN1078 based on emerging safety observations and overall benefit-risk assessment of 1078
Phase III Small-cell Lung Cancer trial by Norwegian University of Science and Technology. Stop reason: SAFETY.
Termination was adviced by Data Safety Committee due to excess toxicity of the experimental treatment.
Phase I Dilated Cardiomyopathy trial by AstraZeneca. Stop reason: SAFETY.
The study has been terminated due to adverse finding in a non-clinical, chronic toxicology study.
Phase I Acute Myeloid Leukemia trial by H. Lee Moffitt Cancer Center and Research Institute. Stop reason: SAFETY.
Toxicity -Two DLT events occurred
Phase I Solid Tumour trial by Genentech, Inc.. Stop reason: SAFETY.
Following a thorough review of safety data, preliminary efficacy data and an evaluation of overall risk-benefit, Sponsor made the decision to end the study.
Phase III Eosinophilic Asthma trial by Areteia Therapeutics. Stop reason: SAFETY.
Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.
Phase III Eosinophilic Asthma trial by Areteia Therapeutics. Stop reason: SAFETY.
Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.
Phase III Eosinophilic Asthma trial by Areteia Therapeutics. Stop reason: SAFETY.
Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.
Phase II Cervical Dystonia trial by Motric Bio. Stop reason: SAFETY.
Pending further safety evaluation
Phase II HER2-positive Metastatic Breast Cancer trial by Spanish Breast Cancer Research Group. Stop reason: SAFETY.
The study was closed early due to safety concerns and an unfavorable benefit-risk balance. Unexpected high neutropenia rates required a costly sub-study, which was not feasible, forcing the sponsor to terminate the trial prematurely.
Phase II Rheumatoid Arthritis trial by Eli Lilly and Company. Stop reason: SAFETY.
Study terminated due to an unfavourable benefit-risk profile observed in interim data analysis.
Phase III Sickle Cell Disease trial by Pfizer. Stop reason: SAFETY.
Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.
Phase III Sickle Cell Disease trial by Pfizer. Stop reason: SAFETY.
Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.
Phase I Relapsed and/or Refractory Multiple Myeloma trial by Adriana Rossi. Stop reason: SAFETY.
Study closure is due to insufficient supply of study drug.
Phase II Hematologic Malignancies trial by University of California, San Diego. Stop reason: SAFETY.
Toxicity
Phase I Solid Tumors trial by Incyte Corporation. Stop reason: SAFETY.
Study terminated due to safety issues.
Phase II Amyotrophic Lateral Sclerosis trial by Novartis Pharmaceuticals. Stop reason: SAFETY.
Study terminated after assessment of potential benefit-risk from available data
Phase I Neuroblastoma trial by Novartis Pharmaceuticals. Stop reason: SAFETY.
Study halted early due to high toxicity risk (from BHLRM model) in combo treatment and inability to identify recommended Phase 2 dose in initial phase (Phase 1-Part A), making continuation to subsequent phases (Phase 1-Part B and Phase 2) unfeasible.
Phase III Crohn Disease trial by Celgene. Stop reason: SAFETY.
The study has terminated due to non-safety reasons; Business Objectives have changed.
Unknown Postoperative Pain trial by Beijing Tiantan Hospital. Stop reason: SAFETY.
One case with postoperative subdural hematoma was reported to the Institutional Review Board and DMC. This study was suspended. The association with study interventions remained to be explored.
Phase I Immune System Disorder trial by Sanofi. Stop reason: SAFETY.
Terminated due to non-safety reasons
Phase II Diffuse, Intrinsic Pontine Glioma trial by Burzynski Research Institute. Stop reason: SAFETY.
Clinical Hold
Phase I Advanced Solid Tumors trial by BeiGene. Stop reason: SAFETY.
The Sponsor has made the decision to discontinue the clinical development of BGB-30813 and close the study based on imbalanced benefit/risk profile in the BGB-A317-30813-101 study.
Phase II Pompe Disease trial by Amicus Therapeutics. Stop reason: SAFETY.
Per protocol, 3 sequential dose cohorts were planned. Study discontinued by Sponsor based upon serious adverse events in first 2 of 3 participants in Cohort 1.
Phase III Severe Sepsis trial by Centre Hospitalier Universitaire de Nīmes. Stop reason: SAFETY.
Exposure to serious adverse events related to the research (i.e., death), the mnts = 54% versus 58 deaths out of 121 patients = 48%).onitoring committee unanimously recommended discontinuation of the trial.
Phase IV Endovascular Infection trial by West Virginia University. Stop reason: SAFETY.
DSMB recommendation based on safety benefit in Experimental (oral) arm
Phase II Leukemia trial by OHSU Knight Cancer Institute. Stop reason: SAFETY.
No stop-reason text available in the compact dataset.
Phase IV Hypovolemia trial by B. Braun Melsungen AG. Stop reason: SAFETY.
recommended by DSMB
Phase II Sickle Cell Disease trial by Pfizer. Stop reason: SAFETY.
Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.
Unknown Critical Illness trial by Hospices Civils de Lyon. Stop reason: SAFETY.
Data safety monitoring board decision
Phase II Glioblastoma trial by Dana-Farber Cancer Institute. Stop reason: SAFETY.
safety concerns
Phase II Pulmonary Fibrosis trial by The University of Queensland. Stop reason: SAFETY.
Data Safety Monitoring Board recommended cessation due to futility
Phase II Idiopathic Pulmonary Fibrosis trial by Pliant Therapeutics, Inc.. Stop reason: SAFETY.
DSMB recommendation
Phase I Advanced Cancer trial by NuCana plc. Stop reason: SAFETY.
The NuTide:303 study was terminated at NuCana's discretion due to refinement of the pipeline strategy. The overall risk benefit assessment of NUC-3373 remains positive and future NUC-3373 studies are under consideration.
Phase I Refractory Cancer trial by Actuate Therapeutics Inc.. Stop reason: SAFETY.
The decision to conclude study was made to optimize the clinical study design and protocol to further evaluate the safety profile of elraglusib (9-ING-41) in pediatric and adult patients with refractory Ewings Sarcoma.
Phase III Sickle Cell Disease trial by Pfizer. Stop reason: SAFETY.
Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.
Phase I Metastatic Melanoma trial by Gregory Daniels. Stop reason: SAFETY.
Closed because of feasibility and safety issues, didn't reach our end point
Phase III Non-Small Cell Lung Cancer (NSCLC) trial by BeiGene. Stop reason: SAFETY.
Due to safety risks and unfavorable risk-benefit assessment results, the sponsor has decided to voluntarily terminate the study.
Phase II HIV/AIDS trial by Vanderbilt University Medical Center. Stop reason: SAFETY.
DSMB recommendations, laboratory quality control (QC) issues. All lab Q/C issues addressed; DSMB approved study re-opening, but due to length of time required to address lab QC issues, insufficient follow-up time was available to complete study.
Phase II Intrahepatic Cholangiocarcinoma trial by Shandong Cancer Hospital and Institute. Stop reason: SAFETY.
Study was terminated due to unacceptable treatment-related toxicity that raised safety concerns and outweighed the potential benefits.
Phase I Haematological Malignancies trial by AstraZeneca. Stop reason: SAFETY.
Trial terminated based on benefit-risk profile assessment
Phase II Liposarcoma, Dedifferentiated trial by Shanghai Pharma Biotherapeutics USA Inc.. Stop reason: SAFETY.
Although no safety issues with SPH4336 were identified, efficacy in liposarcoma patient was less than anticipated.
Phase I Hypertriglyceridemia trial by Eli Lilly and Company. Stop reason: SAFETY.
The study was terminated due to a change in risk/benefit ratio, which no longer favoured continued development.
Phase III Depressive Disorder, Major trial by Janssen Research & Development, LLC. Stop reason: SAFETY.
42847922MDD3002 was stopped based on the interim analysis (IA) results as recommended by the Independent Data Monitoring Committee (IDMC)
Phase II Renal Insufficiency, Chronic trial by Biogen. Stop reason: SAFETY.
IDMC recommendation for safety concerns
Phase III Renal Insufficiency, Chronic trial by Biogen. Stop reason: SAFETY.
IDMC recommendation for safety concerns
Phase I Renal Insufficiency, Chronic trial by Biogen. Stop reason: SAFETY.
IDMC recommendation for safety concerns
Phase II End-Stage Renal Disease trial by Biogen. Stop reason: SAFETY.
IDMC recommendation for safety concerns
Phase III Cervical Cancer trial by National Institute of Cancerología. Stop reason: SAFETY.
Due to a lack of sufficient resources, the opening was not carried out.
Phase I Renal Insufficiency, Chronic trial by Biogen. Stop reason: SAFETY.
IDMC recommendation for safety concerns
Phase I Adenoid Cystic Carcinoma of the Head and Neck trial by Groupe Oncologie Radiotherapie Tete et Cou. Stop reason: SAFETY.
toxicity
Phase III Squamous Cell Carcinoma of the Head and Neck trial by Groupe Oncologie Radiotherapie Tete et Cou. Stop reason: SAFETY.
toxicity
Phase III Axial Spondyloarthritis trial by Janssen Research & Development, LLC. Stop reason: SAFETY.
This study was stopped because ustekinumab did not achieve key endpoints in a related study. The safety profile was consistent with past ustekinumab studies.
Phase III Axial Spondyloarthritis trial by Janssen Research & Development, LLC. Stop reason: SAFETY.
Neither dose achieved the study's primary or major secondary endpoints. The safety profile was consistent with previous ustekinumab studies.
Phase II Asymptomatic Amyloid-positive trial by Janssen Research & Development, LLC. Stop reason: SAFETY.
Change in benefit-risk profile for individuals with early sporadic Alzheimer Disease because of elevations in liver enzymes in subjects receiving atabecestat
Phase II Dry Eye Syndromes trial by Iacta Pharmaceuticals. Stop reason: SAFETY.
Unexpected adverse events were observed in a subset of patients on drug. In an over abundance of caution the study was terminated. All adverse events resolved with no sequelae.
Phase II Cardiac Arrest trial by Beth Israel Deaconess Medical Center. Stop reason: SAFETY.
Study stopped early after consultation with DSMB
Phase II Metastatic Colorectal Cancer trial by UNICANCER. Stop reason: SAFETY.
Following the presentation of the SUNLIGHT study results at ASCO GI and the rapid change in patient management in the majority of centers, the IDMC experts recommended halting inclusion in the SOREGATT study with immediate effect.