Trial Outcomes & Findings for Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA (NCT NCT05245071)
NCT ID: NCT05245071
Last Updated: 2025-08-29
Results Overview
The ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) determined per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
TERMINATED
PHASE2
22 participants
Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks
2025-08-29
Participant Flow
The study was conducted at 35 investigational sites in 7 countries. A total of 30 participants were screened from 01-Jun-2022 to 01-Dec-2023 of which 8 were screen failures due to not meeting eligibility criteria. The study was terminated as per Sponsor decision and not related to any safety concern.
A total of 22 participants were enrolled in the study. Note: Reason for not completed = Reason for permanent full study intervention discontinuation.
Participant milestones
| Measure |
Tusamitamab Ravtansine 100 Milligrams Per Meter Square (mg/m^2)
Participants received tusamitamab ravtansine 100 mg/m\^2 via intravenous (IV) infusion every 2 weeks (Q2W) until disease progression, unacceptable adverse event (AE), death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
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|---|---|
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Overall Study
STARTED
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22
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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22
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Reasons for withdrawal
| Measure |
Tusamitamab Ravtansine 100 Milligrams Per Meter Square (mg/m^2)
Participants received tusamitamab ravtansine 100 mg/m\^2 via intravenous (IV) infusion every 2 weeks (Q2W) until disease progression, unacceptable adverse event (AE), death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
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Overall Study
Progressive disease
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18
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Overall Study
Adverse event not related to Coronavirus Disease 2019
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2
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Overall Study
Not related to Coronavirus Disease 2019
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2
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Baseline Characteristics
Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Baseline characteristics by cohort
| Measure |
Tusamitamab Ravtansine 100 mg/m^2
n=22 Participants
Participants received tusamitamab ravtansine 100 mg/m\^2 via IV infusion Q2W until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
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Age, Continuous
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63.5 years
STANDARD_DEVIATION 10.1 • n=39 Participants
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Sex: Female, Male
Female
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9 Participants
n=39 Participants
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Sex: Female, Male
Male
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13 Participants
n=39 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=39 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=39 Participants
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Race (NIH/OMB)
White
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17 Participants
n=39 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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4 Participants
n=39 Participants
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PRIMARY outcome
Timeframe: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeksPopulation: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.
The ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) determined per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Tusamitamab Ravtansine 100 mg/m^2
n=22 Participants
Participants received tusamitamab ravtansine 100 mg/m\^2 via IV infusion Q2W until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
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Objective Response Rate (ORR)
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9.1 percentage of participants
Interval 1.12 to 29.16
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SECONDARY outcome
Timeframe: From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeksPopulation: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.
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 or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent disability/incapacity or congenital anomaly/birth defect or was a suspected transmission of any infectious agent via an authorized medicinal product. TEAE was defined as AEs that developed, worsened, or became serious during the treatment-emergent period.
Outcome measures
| Measure |
Tusamitamab Ravtansine 100 mg/m^2
n=22 Participants
Participants received tusamitamab ravtansine 100 mg/m\^2 via IV infusion Q2W until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Any TEAEs
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21 Participants
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Any TESAEs
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7 Participants
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SECONDARY outcome
Timeframe: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeksPopulation: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.
The PFS was defined as the time from the first study treatment administration to the date of the first documented progressive disease (PD) or death due to any cause, whichever came first as per RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression.
Outcome measures
| Measure |
Tusamitamab Ravtansine 100 mg/m^2
n=22 Participants
Participants received tusamitamab ravtansine 100 mg/m\^2 via IV infusion Q2W until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
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Progression-Free Survival (PFS)
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1.87 months
Interval 1.676 to 3.614
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SECONDARY outcome
Timeframe: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeksPopulation: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.
The DCR was defined as the percentage of participants who achieved confirmed CR, PR or stable disease (SD) as BOR as per RECIST v1.1. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. The PR was defined as at least a 30%decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on the study.
Outcome measures
| Measure |
Tusamitamab Ravtansine 100 mg/m^2
n=22 Participants
Participants received tusamitamab ravtansine 100 mg/m\^2 via IV infusion Q2W until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
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Disease Control Rate (DCR)
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36.4 percentage of participants
Interval 17.2 to 59.34
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SECONDARY outcome
Timeframe: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeksPopulation: All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. Only responders (those participants with confirmed CR or PR) were included in the analysis.
The DOR was defined as the time from first documented evidence of CR or PR until PD determined per RECIST v1.1 or death from any cause, whichever occurred first. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Tusamitamab Ravtansine 100 mg/m^2
n=2 Participants
Participants received tusamitamab ravtansine 100 mg/m\^2 via IV infusion Q2W until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
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Duration of Response (DOR)
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NA months
NA indicates that data was not estimable due to insufficient number of participants with events until primary completion date of 06-Mar-2024.
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Adverse Events
Tusamitamab Ravtansine 100 mg/m^2
Serious adverse events
| Measure |
Tusamitamab Ravtansine 100 mg/m^2
n=22 participants at risk
Participants received tusamitamab ravtansine 100 mg/m\^2 via IV infusion Q2W until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
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Infections and infestations
Pneumonia
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9.1%
2/22 • Number of events 3 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Nervous system disorders
Epilepsy
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4.5%
1/22 • Number of events 1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Cardiac disorders
Atrial Flutter
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4.5%
1/22 • Number of events 1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Cardiac disorders
Right Ventricular Failure
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4.5%
1/22 • Number of events 1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
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4.5%
1/22 • Number of events 1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
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4.5%
1/22 • Number of events 1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
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13.6%
3/22 • Number of events 3 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Respiratory, thoracic and mediastinal disorders
Lung Disorder
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4.5%
1/22 • Number of events 1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Respiratory, thoracic and mediastinal disorders
Respiratory Failure
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4.5%
1/22 • Number of events 1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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General disorders
Pain
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4.5%
1/22 • Number of events 1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Other adverse events
| Measure |
Tusamitamab Ravtansine 100 mg/m^2
n=22 participants at risk
Participants received tusamitamab ravtansine 100 mg/m\^2 via IV infusion Q2W until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.
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|---|---|
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Metabolism and nutrition disorders
Decreased Appetite
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40.9%
9/22 • Number of events 10 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Eye disorders
Keratitis
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13.6%
3/22 • Number of events 6 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Eye disorders
Keratopathy
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13.6%
3/22 • Number of events 3 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Vascular disorders
Hypertension
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13.6%
3/22 • Number of events 3 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Respiratory, thoracic and mediastinal disorders
Cough
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13.6%
3/22 • Number of events 3 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Respiratory, thoracic and mediastinal disorders
Nasal Congestion
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9.1%
2/22 • Number of events 2 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Gastrointestinal disorders
Constipation
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13.6%
3/22 • Number of events 3 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Gastrointestinal disorders
Nausea
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27.3%
6/22 • Number of events 7 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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|
Gastrointestinal disorders
Stomatitis
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9.1%
2/22 • Number of events 2 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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|
Gastrointestinal disorders
Vomiting
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9.1%
2/22 • Number of events 3 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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|
Musculoskeletal and connective tissue disorders
Arthralgia
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13.6%
3/22 • Number of events 3 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
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13.6%
3/22 • Number of events 3 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
|
|
Renal and urinary disorders
Renal Failure
|
9.1%
2/22 • Number of events 2 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
|
|
General disorders
Asthenia
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27.3%
6/22 • Number of events 7 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
|
|
General disorders
Fatigue
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13.6%
3/22 • Number of events 3 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
|
|
General disorders
Non-Cardiac Chest Pain
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13.6%
3/22 • Number of events 3 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
|
|
General disorders
Oedema Peripheral
|
9.1%
2/22 • Number of events 2 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
|
|
General disorders
Pyrexia
|
9.1%
2/22 • Number of events 2 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
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Investigations
Weight Decreased
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13.6%
3/22 • Number of events 3 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks. All-cause mortality (death) was assessed from signing of the informed consent form (Day -28) to study termination, up to 129 weeks.
Analysis was performed on all-treated population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER