Trial Outcomes & Findings for Assessment of Helical Tomotherapy Radiotherapy (54 Gy) Followed by Surgery in Retro-peritoneal Liposarcoma (NCT NCT01841047)
NCT ID: NCT01841047
Last Updated: 2025-09-03
Results Overview
Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable. The effectiveness will be evaluated in terms of local recurrence-free survival 3 years. Given the data and the lack of independence between local recurrence and metastasis events, the Kaplan Meier method cannot be applied. An estimation method adapted to the presence of competing risks is necessary. Including other events (metastasis, deaths...) consist in using a competing risk analysis methodology where the specific incidence of each type of event is estimated in the presence of the other types of events. The following results represent the cumulative incidence (as a percentage) of local recurrence on the one hand and the cumulative incidence of competing risks (distant metastasis or death) on the other hand.
COMPLETED
NA
48 participants
3 years from start of the tomotherapy treatment
2025-09-03
Participant Flow
3 recruitment centers : * Institut Bergonié - Bordeaux * Claudius Régaud - Toulouse * René Gauducheau - Nantes
Participant milestones
| Measure |
Radiotherapy
Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.
Helical tomotherapy (54 Gy) will take place over 6 consecutive weeks with 30 fractions of 1.8 Gy : 5 fractions per week followed by 2 days off. The surgery takes place between 2 and 8 weeks after the end of the tomotherapy.
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Overall Study
STARTED
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48
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Overall Study
COMPLETED
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48
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 patient with data not available
Baseline characteristics by cohort
| Measure |
Radiotherapy
n=48 Participants
Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.
Radiotherapy: Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable
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Age, Categorical
<=18 years
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0 Participants
n=48 Participants
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Age, Categorical
Between 18 and 65 years
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29 Participants
n=48 Participants
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Age, Categorical
>=65 years
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19 Participants
n=48 Participants
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Age, Continuous
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63.1 years
n=48 Participants
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Sex: Female, Male
Female
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22 Participants
n=48 Participants
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Sex: Female, Male
Male
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26 Participants
n=48 Participants
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Region of Enrollment
France
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48 participants
n=48 Participants
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WHO status
0
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31 Participants
n=47 Participants • 1 patient with data not available
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WHO status
1
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13 Participants
n=47 Participants • 1 patient with data not available
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WHO status
2
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2 Participants
n=47 Participants • 1 patient with data not available
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WHO status
3
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1 Participants
n=47 Participants • 1 patient with data not available
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WHO status
4
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0 Participants
n=47 Participants • 1 patient with data not available
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Histotype
Liposarcoma well differentiated
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20 Participants
n=48 Participants
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Histotype
Liposarcoma dedifferentiated or pleomorphic
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28 Participants
n=48 Participants
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PRIMARY outcome
Timeframe: 3 years from start of the tomotherapy treatmentPopulation: All patients
Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable. The effectiveness will be evaluated in terms of local recurrence-free survival 3 years. Given the data and the lack of independence between local recurrence and metastasis events, the Kaplan Meier method cannot be applied. An estimation method adapted to the presence of competing risks is necessary. Including other events (metastasis, deaths...) consist in using a competing risk analysis methodology where the specific incidence of each type of event is estimated in the presence of the other types of events. The following results represent the cumulative incidence (as a percentage) of local recurrence on the one hand and the cumulative incidence of competing risks (distant metastasis or death) on the other hand.
Outcome measures
| Measure |
Radiotherapy
n=48 Participants
Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.
Radiotherapy: Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable
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|---|---|
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Cumulative Incidence Rate of Local Recurrence and Competing Risks (All Patients)
Cumulative incidence rate of local recurrence
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16.89 percentage of participants
Interval 7.9 to 28.75
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Cumulative Incidence Rate of Local Recurrence and Competing Risks (All Patients)
Cumulative incidence rate of competing risks
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10.42 percentage of participants
Interval 3.82 to 20.86
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PRIMARY outcome
Timeframe: 3 years from start of the tomotherapy treatmentPopulation: Analysis for the 20 patients with well-differentiated liposarcoma
Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable. The effectiveness will be evaluated in terms of local recurrence-free survival 3 years.Given the data and the lack of independence between local recurrence and metastasis events, the Kaplan Meier method cannot be applied. An estimation method adapted to the presence of competing risks is necessary. Including other events (metastasis, deaths...) consist in using a competing risk analysis methodology where the specific incidence of each type of event is estimated in the presence of the other types of events. The following results represent the cumulative incidence (as a percentage) of local recurrence on the one hand and the cumulative incidence of competing risks (distant metastasis or death) on the other hand.
Outcome measures
| Measure |
Radiotherapy
n=20 Participants
Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.
Radiotherapy: Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable
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|---|---|
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Cumulative Incidence Rate of Local Recurrence and Competing Risks (Liposarcoma Well Differentiated)
Cumulative incidence rate of local recurrence
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5.00 percentage of participants
Interval 0.35 to 20.53
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Cumulative Incidence Rate of Local Recurrence and Competing Risks (Liposarcoma Well Differentiated)
Cumulative incidence rate of competing risks
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5.00 percentage of participants
Interval 0.35 to 20.53
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PRIMARY outcome
Timeframe: 3 years from start of the tomotherapy treatmentPopulation: Analysis for the 28 patients with dedifferentiated or pleomorphic liposarcoma
Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable. The effectiveness will be evaluated in terms of local recurrence-free survival 3 years.Given the data and the lack of independence between local recurrence and metastasis events, the Kaplan Meier method cannot be applied. An estimation method adapted to the presence of competing risks is necessary. Including other events (metastasis, deaths...) consist in using a competing risk analysis methodology where the specific incidence of each type of event is estimated in the presence of the other types of events. The following results represent the cumulative incidence (as a percentage) of local recurrence on the one hand and the cumulative incidence of competing risks (distant metastasis or death) on the other hand.
Outcome measures
| Measure |
Radiotherapy
n=28 Participants
Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.
Radiotherapy: Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable
|
|---|---|
|
Cumulative Incidence Rate of Local Recurrence and Competing Risks (Liposarcoma Dedifferentiated or Pleomorphic)
Cumulative incidence rate of local recurrence
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25.71 percentage of participants
Interval 11.36 to 42.82
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Cumulative Incidence Rate of Local Recurrence and Competing Risks (Liposarcoma Dedifferentiated or Pleomorphic)
Cumulative incidence rate of competing risks
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14.29 percentage of participants
Interval 4.5 to 29.5
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SECONDARY outcome
Timeframe: 3 years from start of the tomotherapy treatmentPopulation: All patients
Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable. The effectiveness will be evaluated in terms of disease free survival rate at 3 years, with the kaplan-meier method. The disease-free survival time is calculated between the date of the start of the tomotherapy treatment and the date of death, distant metastasis or local recurrence (events), whichever occur first, or the date of last news (censorship).
Outcome measures
| Measure |
Radiotherapy
n=48 Participants
Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.
Radiotherapy: Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable
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|---|---|
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Percentage of Participants With Disease-Free Survival (All Patients)
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72.70 percentage of participants
Interval 57.65 to 83.14
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SECONDARY outcome
Timeframe: 3 years from start of the tomotherapy treatmentPopulation: Analysis for the 20 patients with well-differentiated liposarcoma
Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable. The effectiveness will be evaluated in terms of disease free survival rate at 3 years, with the kaplan-meier method. The disease-free survival time is calculated between the date of the start of the tomotherapy treatment and the date of death, distant metastasis or local recurrence (events), whichever occur first, or the date of last news (censorship).
Outcome measures
| Measure |
Radiotherapy
n=20 Participants
Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.
Radiotherapy: Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable
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|---|---|
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Percentage of Participants With Disease-Free Survival (Liposarcoma Well Differentiated)
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90.00 percentage of participants
Interval 65.6 to 97.4
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SECONDARY outcome
Timeframe: 3 years from start of the tomotherapy treatmentPopulation: Analysis for the 28 patients with dedifferentiated or pleomorphic liposarcoma
Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable. The effectiveness will be evaluated in terms of disease free survival rate at 3 years, with the kaplan-meier method. The disease-free survival time is calculated between the date of the start of the tomotherapy treatment and the date of death, distant metastasis or local recurrence (events), whichever occur first, or the date of last news (censorship).
Outcome measures
| Measure |
Radiotherapy
n=28 Participants
Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.
Radiotherapy: Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable
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|---|---|
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Percentage of Participants With Disease-Free Survival (Liposarcoma Dedifferentiated or Pleomorphic)
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60.00 percentage of participants
Interval 39.45 to 75.54
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SECONDARY outcome
Timeframe: 1 year, 3 years and 5 years from start of the tomotherapy treatmentPopulation: All patients
Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable. The effectiveness will be evaluated in terms of overall survival rate at 1, 3 and 5 years, with the kaplan-meier method. The overall survival time is calculated between the date of the start of the tomotherapy treatment and the date of death (event), or the date of last news (censorship).
Outcome measures
| Measure |
Radiotherapy
n=48 Participants
Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.
Radiotherapy: Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable
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|---|---|
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Percentage of Participants With Overall Survival (All Patients)
1-year Overall survival rate
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93.62 percentage of participants
Interval 81.5 to 97.9
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Percentage of Participants With Overall Survival (All Patients)
3-years Overall survival rate
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80.60 percentage of participants
Interval 66.02 to 89.4
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Percentage of Participants With Overall Survival (All Patients)
5-years Overall survival rate
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73.94 percentage of participants
Interval 58.67 to 84.29
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Adverse Events
Radiotherapy
Serious adverse events
| Measure |
Radiotherapy
n=48 participants at risk
Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.
Radiotherapy: Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable
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|---|---|
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Blood and lymphatic system disorders
Anemia
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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Endocrine disorders
Adrenal insufficiency
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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Gastrointestinal disorders
Colonic fistula
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
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4.2%
2/48 • Number of events 2 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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Gastrointestinal disorders
Gastrointestinal fistula
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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Gastrointestinal disorders
Pancreatitis
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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Gastrointestinal disorders
Rectal hemorrhage
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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Gastrointestinal disorders
Small intestinal obstruction
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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General disorders
Death NOS
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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General disorders
Disease progression
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16.7%
8/48 • Number of events 8 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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General disorders
Sudden death NOS
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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Infections and infestations
Abdominal infection
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
|
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Infections and infestations
Infections and infestations - Other, specify
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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Infections and infestations
Lung infection
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
|
|
Infections and infestations
Skin infection
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
|
|
Injury, poisoning and procedural complications
Vascular access complication
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
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Investigations
Weight loss
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
|
|
Metabolism and nutrition disorders
Anorexia
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
14.6%
7/48 • Number of events 7 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
|
|
Vascular disorders
Lymphocele
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2.1%
1/48 • Number of events 1 • 5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other \[Not Including Serious\] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place