Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
This is a Phase II, randomized, blinded, active-controlled, global, multicenter study designed to evaluate the safety and efficacy of lomvastomig and tobemstomig, compared with nivolumab, in patients with advanced or metastatic esophageal squamous-cell carcinoma (ESCC) refractory or intolerant to fluoropyrimidine- or taxane- and platinum-based regimen. Following approval of the protocol amendment version 3, recruitment into the lomvastomig arm has been stopped. The decision to stop recruitment for lomvastomig was based on strategic considerations and not based on emerging safety and/or efficacy data. The benefit/risk assessment for lomvastomig remains unchanged. The study was planned to enroll participants randomized in a 1:1:1 ratio to receive lomvastomig, tobemstomig, or nivolumab. With version 3 of the protocol, recruitment into the lomvastomig arm has stopped, and moving forward, participants will be randomized in a 1:1 ratio to receive either tobemstomig or nivolumab.
Interventions
DRUGLomvastomig
2100 milligrams (mg) administered by intravenous (IV) infusion once every 2 weeks on Day 1 of each 14-day cycle.
DRUGTobemstomig
2100 mg administered by IV infusion once every 2 weeks on Day 1 of each 14-day cycle.
DRUGNivolumab
240 mg administered by IV infusion once every 2 weeks on Day 1 of each 14-day cycle.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced or metastatic, histologically confirmed esophageal squamous-cell carcinoma (ESCC) * Patients who have previously received 1 line of treatment with either a fluoropyrimidine- and platinum- or a taxane- and platinum-based regimen in non-curative intention prior to randomization; or patients who received treatment with a fluoropyrimidine-/taxane- and platinum-based regimen in curative intention and had recurrence or progression within 24 weeks after the last dose of the treatment * Radiologically measurable disease according to RECIST v1.1. Previously irradiated lesions should not be counted as target lesions unless clearly progressed after the radiotherapy * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * A life expectancy of at least (≥)12 weeks * Tissue samples must be provided for analysis of anti-programmed death ligand-1 (PD-L1) tumor positivity * Adverse events from any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade ≤1, except alopecia (any grade), vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 peripheral neuropathy * Adequate cardiovascular, hematological, liver, and renal function * Serum albumin ≥25 grams per liter (g/L), * For participants not receiving therapeutic anticoagulation: prothrombin time (PT) and activated partial thromboplastin time ≤1.5 times (×) the upper limit of normal (ULN); for participants receiving therapeutic anticoagulation: stable anticoagulant regimen * A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP), or a WOCBP who agrees to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods during the treatment period and for at least 5 months after the final dose of study drug and have a negative pregnancy test (blood) within the 7 days prior to randomization. * A male participant must remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom plus an additional contraceptive method and refrain from donating sperm during the treatment period and for at least 5 months after the final dose of study drug
Exclusion criteria
* Pregnancy, lactation, or breastfeeding * Known hypersensitivity to any of the components of RO7121661, RO7247669, or nivolumab, including but not limited to, hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies * Patients with significant malnutrition. Patients whose nutrition has been well controlled for ≥28 days prior to randomization may be enrolled * Evidence of complete esophageal obstruction not amenable to treatment * Higher risk of bleeding or fistula caused by esophageal lesions invading adjacent organs (aorta or tracheobronchial tree). Patients with manageable fistula may be included at the Investigator's discretion. * Symptomatic central nervous system (CNS) metastases * Spinal cord compression not definitively treated with surgery and/or radiation or without evidence that disease has been clinically stable for ≥14 days prior to randomization * Active or history of carcinomatous meningitis/leptomeningeal disease * Asymptomatic CNS primary tumors or metastases if they have requirement for steroids or enzyme inducing anticonvulsants in the last 28 days prior to randomization * Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry * Active second malignancy (with some exceptions) * Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, known autoimmune diseases or immune deficiency, or other diseases with ongoing fibrosis (such as scleroderma, pulmonary fibrosis, emphysema, neurofibromatosis, palmar/plantar fibromatosis, etc.). * Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent * Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization * Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis \[TB\] and typical mycobacterial disease), parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization (relating to the completion of the course of antibiotics, except if for tumor fever) within 28 days prior to randomization * Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, and inherited liver disease. * Major surgical procedure or significant traumatic injury (excluding biopsies) within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications * Dementia or altered mental status that would prohibit informed consent * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (expected to occur once monthly or more frequently) * Active or history of autoimmune disease or immune deficiency * Positive human immunodeficiency virus (HIV) test at screening * Positive hepatitis B surface antigen (HBsAg) or positive total hepatitis B core antibody (HBcAb) test at screening * Positive hepatitis C virus (HCV) antibody test at screening * Prior cancer therapy with any immunomodulatory agents including checkpoint inhibitors (CPIs; such as anti-PDL1/PD1, anti-CTLA-4, anti-LAG3, anti-TIM3) * Vaccination with live vaccines within 28 days prior to randomization, or anticipation that a live attenuated vaccine will be required during the study * Treatment with therapeutic oral or IV antibiotics within 14 days prior to randomization * Concurrent therapy with any other investigational drug (defined as treatment for which there is currently no regulatory authority approved indication) 28 days or 5 half-lives of the drug (whichever is shorter) prior to randomization * Treatment with immune-modulating and immune suppressive agents/medication 5 half-lives or 28 days (whichever is shorter) prior to randomization * Regular immunosuppressive therapy (i.e., for organ transplantation, chronic rheumatologic disease) * Radiotherapy within the last 28 days before start of study drug treatment is not allowed, with the exception of limited palliative radiotherapy * Prior treatment with adoptive cell therapies, such as chimeric antigen receptor T cells (CAR-T) therapies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From randomization to death (up to approximately 38.7 months) | OS was defined as the time from randomization to death from any cause. Kaplan-Meier (K-M) method was used to estimate median OS. 80% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley. IxRS=Interactive response system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to approximately 27 months | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Objective Response Rate (ORR) | Up to approximately 38.7months | ORR was defined as the percentage of participants who have achieved an objective response (OR), characterized by a complete response (CR) or partial response (PR), as per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. 80% CI for rates were constructed using the Clopper-Pearson method. Percentages have been rounded off. |
| Disease Control Rate (DCR) | Up to approximately 38.7 months | DCR was defined as ORR plus stable disease rate (SDR). ORR was defined as the percentage of participants who have achieved an OR, characterized by a CR or PR as per RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and unequivocal progression of existing non-target lesions. 80% CI for rates were constructed using the Clopper-Pearson method. Percentages have been rounded off. |
| Duration of Response (DoR) | Up to approximately 38.7 months | DoR for participants with ORR was defined as time from first occurrence of a documented OR to PD as per RECIST v1.1 or death from any cause, whichever occurs first. ORR was defined as the percentage of participants who have achieved an OR, chaacterized by a CR or PR as per RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and unequivocal progression of existing non-target lesions. K-M method was used to estimate median DOR. 80% CI for median was computed using the method of Brookmeyer and Crowley. |
| Progression-free Survival (PFS) | Up to approximately 38.7 months | PFS was defined as the time from randomization to the first occurrence of PD, as determined per RECIST v1.1, or death during the treatment period, or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS. 80% CI for median was computed using the method of Brookmeyer and Crowley. |
| Percentage of Participants Reporting Clinically Meaningful Improvement in GHS/QoL, Emotional and Social Functioning as Measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire (QLQ)-C30 | From baseline up to Week 12 | EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, \& social), 3 symptom scales (fatigue, nausea, vomiting, \& pain), global health status (GHS)/quality of life (QoL), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Functioning \& symptom items were scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. The GHS/QoL questions were scored on a 7-point scale with scores ranging from 1=Very poor to 7=Excellent. All EORTC scales \& single-item measures were linearly transformed to a score range of 0-100. High score for a functioning/GHS scale=high/healthy level of functioning/better HRQoL; however, high score for a symptom scale=high level of symptom severity. Clinically significant improvement=an increase of at least 10 points from baseline in GHS/QoL, emotional and social functioning. |
| Percentage of Participants Reporting Clinically Meaningful Improvement in GHS/QoL, Emotional and Social Functioning, as Measured by the EORTC QLQ - Item Library 97 (IL97) | From baseline up to Week 12 | EORTC QLQ-IL97, a reduced version of the QLQ-C30, is a cancer-specific instrument consisting of 17 questions to evaluate two aspects of participant functioning (emotional and social), GHS/QoL, and six symptoms (fatigue, nausea, vomiting, pain, appetite loss, \& diarrhoea), with a recall period of the previous week. The scoring for the IL97 followed the same pattern as the QLQ-C30. Functioning \& symptom items were scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. The GHS/QoL questions were scored on a 7-point scale with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a range of 0-100. High score for a functioning/GHS scale=high/healthy level of functioning/better HRQoL; however, high score for a symptom scale=high level of symptom severity. Clinically significant improvement=an increase of at least 10 points from baseline in GHS/QoL, emotional and social functioning. |
| Percentage of Participants Reporting a Clinically Meaningful Improvement in Dysphagia, as Measured by the EORTC QLQ for Oesophageal Cancer-18 (OES-18) | From baseline up to Week 12 | EORTC QLQ-OES18, a modular supplement to the EORTC QLQ-C30, is a cancer-specific instrument, consisting of 4 multiple-item scales (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. The scoring for the OES18 followed the same pattern as the QLQ-C30. 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 0-100, with a high score reflecting a high level of symptom severity. Clinically significant improvement=an increase of at least 10 points from baseline in GHS/QoL, emotional and social functioning. |
| Serum Concentration of Nivolumab | 4 hours (h) pre-dose, and 1 & 5 h post-dose on Day 1 of Cycle 1; pre-dose, and 0.5 & 4.5 h post-dose on Day 1 of Cycles 2 & 5; 168 h post-dose on Day 8 of Cycles 1 & 5; pre-dose, and 0.5 h post-dose on Day 1 of Cycles 3, 4 & 6 to 52 (1 Cycle=14 days) | — |
| Serum Concentration of Lomvastomig | 4h pre-dose, and 1 & 5 h post-dose on Day 1 of Cycle 1; pre-dose, and 0.5 & 4.5 h post-dose on Day 1 of Cycles 2 & 5; 168 h post-dose on Day 8 of Cycles 1 & 5; pre-dose, and 0.5 h post-dose on Day 1 of Cycles 3, 4 & 6 to 19 (1 Cycle=14 days) | — |
| Serum Concentration of Tobemstomig | 4h pre-dose, and 1 & 5 h post-dose on Day 1 of Cycle 1; pre-dose, and 0.5 & 4.5 h post-dose on Day 1 of Cycles 2 & 5; 168 h post-dose on Day 8 of Cycles 1 & 5; pre-dose, and 0.5 h post-dose on Day 1 of Cycles 3, 4 & 6 to 52 (1 Cycle=14 days) | — |
| Maximum Observed Serum Concentration (Cmax) of Nivolumab | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| Cmax of Lomvastomig | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| Cmax of Tobemstomig | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| Terminal Half-life (λz) of Nivolumab | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| λz of Lomvastomig | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| λz of Tobemstomig | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| Area Under the Curve From Dosing to Last Concentration (AUClast) of Nivolumab | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | day\*µg/mL=days-micrograms per milliliter. |
| AUClast of Lomvastomig | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| AUClast of Tobemstomig | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| Estimate of the Volume of Distribution at Steady-state (Vss_obs) of Nivolumab | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| Vss_obs of Lomvastomig | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| Vss_obs of Tobemstomig | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| Total Clearance (Cl_obs) of Nivolumab | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| Cl_obs of Lomvastomig | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| Cl_obs of Tobemstomig | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | — |
| Number of Participants With Anti-drug Antibodies (ADAs) to Nivolumab | Up to approximately 24 months | Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following nivolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). |
| Number of Participants With ADAs to Lomvastomig | Up to approximately 8.4 months | Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following lomvastomig administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). |
| Number of Participants With ADAs to Tobemstomig | Up to approximately 24 months | Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following tobemstomig administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). |
| Change From Baseline in the Phenotype and Activation Status (Cluster of Differentiation 4 [CD4] Human Leukocyte Antigen - DR Isotype-positive [HLA-DR+] Kiel 67-positive [Ki67+]) of T-cell Subsets in the Peripheral Blood | Day 1 of Cycles 1, 2, 3, 5, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51; Day 8 of Cycles 1 & 5; Study drug completion / Early discontinuation visit; (1 Cycle=14 days) (up to 24 months) | Biomarker analyses were performed on peripheral blood samples collected from participants and assessed by flow cytometry. Zeros are present when no valid samples for PD assessments were collected/available at the respective visits. As the number of participants in the lomvastomig arm was more limited, chances to observe zeros are higher in this arm vs the other arms. |
| Change From Baseline in the Phenotype and Activation Status (Cluster of Differentiation 8 [CD8] HLA-DR+ Ki67+) of T-cell Subsets in the Peripheral Blood | Day 1 of Cycles 1, 2, 3, 5, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51; Day 8 of Cycles 1 & 5; Study drug completion / Early discontinuation visit; (1 Cycle=14 days) (up to 24 months) | Biomarker analyses were performed on peripheral blood samples collected from participants and assessed by flow cytometry. Zeros are present when no valid samples for PD assessments were collected/available at the respective visits. As the number of participants in the lomvastomig arm was more limited, chances to observe zeros are higher in this arm vs the other arms. |
| Baseline CD8 T-cell Infiltration, Poliferation (Cluster of Differentiation 8-positive Subunit Alpha [CD8A+] Ki67+) Expression in the Tumor Microenvironment | At baseline | CD8 T-cell infiltration, poliferation (CD8A+ Ki67+) expression in the tumor microenvironment at baseline, was assessed from previously collected tumour samples (archival samples). For participants without an available archival tumor sample, a fresh tumor sample was collected during the screening. Both archival and screening samples were considered baseline samples to assess biomarkers within the tumor microenvironment. |
| Baseline Anti-programmed Death-1 (PDL1) Expression in the Tumor Microenvironment | At baseline | Anti-PDL1 expression in the tumor microenvironment at baseline, was assessed from previously collected tumour samples (archival samples). For participants without an available archival tumor sample, a fresh tumor sample was collected during the screening. Both archival and screening samples were considered as baseline samples to assess biomarkers within the tumor microenvironment. |
| Baseline CD8A+ Anti-programmed Death-1-positive (PD1+) Expression in the Tumor Microenvironment | At Baseline | CD8A+ Anti-PD1+ expression in the tumor microenvironment at baseline, was assessed from previously collected tumour samples (archival samples). For participants without an available archival tumor sample, a fresh tumor sample was collected during the screening. Both archival and screening samples were considered as baseline samples to assess biomarkers within the tumor microenvironment. |
| Baseline CD8A+ T-cell Immunoglobulin and Mucin Domain 3-positive (TIM3+) Expression in the Tumor Microenvironment | At Baseline | CD8A+ TIM3+ expression in the tumor microenvironment at baseline, was assessed from previously collected tumour samples (archival samples). For participants without an available archival tumor sample, a fresh tumor sample was collected during the screening. Both archival and screening samples were considered as baseline samples to assess biomarkers within the tumor microenvironment. |
| Baseline CD8A+ Lymphocyte-Activation Gene 3-positive (LAG3+) Expression in the Tumor Microenvironment | At Baseline | CD8A+ LAG3+ expression in the tumor microenvironment at baseline, was assessed from previously collected tumour samples (archival samples). For participants without an available archival tumor sample, a fresh tumor sample was collected during the screening. Both archival and screening samples were considered as baseline samples to assess biomarkers within the tumor microenvironment. |
Countries
Argentina, Brazil, Czechia, Denmark, France, Hungary, Italy, Kenya, Poland, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Participant flow
Recruitment details
A total of 190 participants with advanced or metastatic esophageal squamous-cell carcinoma (ESCC) refractory or intolerant to fluoropyrimidine- or taxane- and platinum-based regimen took part in the study at 81 investigative sites across 21 countries from 25 June 2021 to 30 January 2025.
Pre-assignment details
Participants were randomized in a 1:1:1 ratio to receive nivolumab, tobemstomig (RO7247669), or lomvastomig (RO7121661). From Protocol Version 3 onwards, recruitment into the lomvastomig arm was stopped and participants were randomized in a 1:1 ratio to receive either nivolumab or tobemstomig. Two participants did not receive any study treatment and were excluded from the safety analysis.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 24 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 119 Participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 67 / 79 | 24 / 27 | 68 / 82 |
| other Total, other adverse events | 60 / 79 | 24 / 27 | 67 / 82 |
| serious Total, serious adverse events | 32 / 79 | 10 / 27 | 39 / 82 |
Outcome results
None listed