Trial Outcomes & Findings for Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma (NCT NCT01344018)
NCT ID: NCT01344018
Last Updated: 2023-04-24
Results Overview
Abdominal recurrence was defined by one of the following events: local/abdominal or distant progressive disease during preoperative radiotherapy (as per RECIST 1.1), tumor or patient becoming inoperable (ASA score of 3 or involvement of superior mesenteric artery, aorta, or bone), peritoneal metastasis found at surgery, macroscopic residual disease left in at surgery (R2 resection), or local relapse (after macroscopically complete resection). Liver metastases were regarded as distant metastatic events. Patients with distant metastases were followed until local failure was detected. Patients without one of these events were censored at the date of last follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
266 participants
Primary outcome timeframe
ARFS was measured from date of randomization to date of abdominal relapse or death, whichever occurred first, up to a maximum of 7 years.
Results posted on
2023-04-24
Participant Flow
A total of 266 (216 by EORTC members and 50 by non-EORTC members) patients were registered by 30 institutions between January 18, 2012 and April 10, 2017.
Participant milestones
| Measure |
Surgery Alone
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
therapeutic conventional surgery
|
Preoperative Radiotherapy Followed by En-bloc Surgery
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
therapeutic conventional surgery
3-dimensional conformal radiation therapy
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
133
|
|
Overall Study
COMPLETED
|
107
|
101
|
|
Overall Study
NOT COMPLETED
|
26
|
32
|
Reasons for withdrawal
| Measure |
Surgery Alone
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
therapeutic conventional surgery
|
Preoperative Radiotherapy Followed by En-bloc Surgery
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
therapeutic conventional surgery
3-dimensional conformal radiation therapy
|
|---|---|---|
|
Overall Study
Death
|
22
|
25
|
|
Overall Study
Lost to Follow-up
|
4
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Surgery Alone
n=133 Participants
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
therapeutic conventional surgery
|
Preoperative Radiotherapy Followed by En-bloc Surgery
n=133 Participants
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
therapeutic conventional surgery
3-dimensional conformal radiation therapy
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
Canada
|
13 participants
n=133 Participants
|
15 participants
n=133 Participants
|
28 participants
n=266 Participants
|
|
Age, Continuous
|
61 years
n=133 Participants
|
61 years
n=133 Participants
|
61 years
n=266 Participants
|
|
Age, Customized
<= 50 years
|
29 Participants
n=133 Participants
|
26 Participants
n=133 Participants
|
55 Participants
n=266 Participants
|
|
Age, Customized
51 - 65 years
|
58 Participants
n=133 Participants
|
59 Participants
n=133 Participants
|
117 Participants
n=266 Participants
|
|
Age, Customized
> 65 years
|
46 Participants
n=133 Participants
|
48 Participants
n=133 Participants
|
94 Participants
n=266 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=133 Participants
|
71 Participants
n=133 Participants
|
138 Participants
n=266 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=133 Participants
|
62 Participants
n=133 Participants
|
128 Participants
n=266 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=133 Participants
|
4 participants
n=133 Participants
|
7 participants
n=266 Participants
|
|
Region of Enrollment
United Kingdom
|
16 participants
n=133 Participants
|
10 participants
n=133 Participants
|
26 participants
n=266 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=133 Participants
|
1 participants
n=133 Participants
|
2 participants
n=266 Participants
|
|
Region of Enrollment
Netherlands
|
10 participants
n=133 Participants
|
11 participants
n=133 Participants
|
21 participants
n=266 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=133 Participants
|
1 participants
n=133 Participants
|
2 participants
n=266 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=133 Participants
|
5 participants
n=133 Participants
|
6 participants
n=266 Participants
|
|
Region of Enrollment
Norway
|
6 participants
n=133 Participants
|
7 participants
n=133 Participants
|
13 participants
n=266 Participants
|
|
Region of Enrollment
Denmark
|
3 participants
n=133 Participants
|
1 participants
n=133 Participants
|
4 participants
n=266 Participants
|
|
Region of Enrollment
Poland
|
6 participants
n=133 Participants
|
5 participants
n=133 Participants
|
11 participants
n=266 Participants
|
|
Region of Enrollment
Italy
|
33 participants
n=133 Participants
|
32 participants
n=133 Participants
|
65 participants
n=266 Participants
|
|
Region of Enrollment
France
|
38 participants
n=133 Participants
|
41 participants
n=133 Participants
|
79 participants
n=266 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=133 Participants
|
0 participants
n=133 Participants
|
2 participants
n=266 Participants
|
|
WHO performance status
PS 0: able to carry out all normal activity without restriction
|
100 Participants
n=133 Participants
|
110 Participants
n=133 Participants
|
210 Participants
n=266 Participants
|
|
WHO performance status
PS 1: restricted in strenuous activity but ambulatory and able to carry out light work
|
33 Participants
n=133 Participants
|
22 Participants
n=133 Participants
|
55 Participants
n=266 Participants
|
|
WHO performance status
PS 2: ambulatory and capable of all self-care but unable to carry out any work activities
|
0 Participants
n=133 Participants
|
1 Participants
n=133 Participants
|
1 Participants
n=266 Participants
|
|
Concomitant non-malignant disease
No
|
70 Participants
n=133 Participants
|
58 Participants
n=133 Participants
|
128 Participants
n=266 Participants
|
|
Concomitant non-malignant disease
Yes
|
63 Participants
n=133 Participants
|
74 Participants
n=133 Participants
|
137 Participants
n=266 Participants
|
|
Concomitant non-malignant disease
Missing
|
0 Participants
n=133 Participants
|
1 Participants
n=133 Participants
|
1 Participants
n=266 Participants
|
PRIMARY outcome
Timeframe: ARFS was measured from date of randomization to date of abdominal relapse or death, whichever occurred first, up to a maximum of 7 years.Abdominal recurrence was defined by one of the following events: local/abdominal or distant progressive disease during preoperative radiotherapy (as per RECIST 1.1), tumor or patient becoming inoperable (ASA score of 3 or involvement of superior mesenteric artery, aorta, or bone), peritoneal metastasis found at surgery, macroscopic residual disease left in at surgery (R2 resection), or local relapse (after macroscopically complete resection). Liver metastases were regarded as distant metastatic events. Patients with distant metastases were followed until local failure was detected. Patients without one of these events were censored at the date of last follow-up.
Outcome measures
| Measure |
Surgery Alone
n=133 Participants
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
therapeutic conventional surgery
|
Preoperative Radiotherapy Followed by En-bloc Surgery
n=133 Participants
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
therapeutic conventional surgery
3-dimensional conformal radiation therapy
|
|---|---|---|
|
Number of Patients With Abdominal Recurrence or Death
Event
|
61 Participants
|
60 Participants
|
|
Number of Patients With Abdominal Recurrence or Death
No event
|
72 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: From date of randomization to the date of surgical procedure, prior to surgeryPopulation: Only patients in the "Preoperative radiotherapy followed by en-bloc surgery" that received at least one dose of radiotherapy were considered for this secondary endpoint.
The acute toxicity was assessed in randomized patients who received at least one dose of preoperative radiotherapy (RT). It follows Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 in the RT safety population, assuming the following classification: * Grade 0 No event reported * Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. * Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. * Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. * Grade 4 Life-threatening consequences; urgent intervention indicated. * Grade 5 Death related to AE. For each item of the CTCAE, the worst grade of acute toxicity from the data of randomization prior to surgery was taken
Outcome measures
| Measure |
Surgery Alone
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
therapeutic conventional surgery
|
Preoperative Radiotherapy Followed by En-bloc Surgery
n=127 Participants
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
therapeutic conventional surgery
3-dimensional conformal radiation therapy
|
|---|---|---|
|
Acute Toxicity Profile of Preoperative Radiotherapy.
CTCAE Grade 0
|
—
|
4 Participants
|
|
Acute Toxicity Profile of Preoperative Radiotherapy.
CTCAE Grade 1-2
|
—
|
106 Participants
|
|
Acute Toxicity Profile of Preoperative Radiotherapy.
CTCAE Grade 4
|
—
|
1 Participants
|
|
Acute Toxicity Profile of Preoperative Radiotherapy.
CTCAE Grade 3
|
—
|
15 Participants
|
|
Acute Toxicity Profile of Preoperative Radiotherapy.
CTCAE Grade 5
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: From the date of surgery, up to 60 days following surgeryPopulation: all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation followed by surgery)
Adverse events and side effects possibly related to surgery were assessed according to the Dindo's classification. This scales the observed side effects as Grade 0 No event Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III Requiring surgical, endoscopic or radiological intervention Grade IV Life-threatening complication (including CNS complications) requiring IC/ICU-management Grade V Death of a patient For each item, the frequency of the worst grade of the observed toxicity was tabulated by treatment group. The perioperative period commence at the time of surgery (at the time of the induction anaesthesia) to the complete closure of the wound.
Outcome measures
| Measure |
Surgery Alone
n=128 Participants
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
therapeutic conventional surgery
|
Preoperative Radiotherapy Followed by En-bloc Surgery
n=119 Participants
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
therapeutic conventional surgery
3-dimensional conformal radiation therapy
|
|---|---|---|
|
Perioperative Complications
Dindo scale Grade 4
|
1 Participants
|
2 Participants
|
|
Perioperative Complications
Dindo scale Grade 0
|
57 Participants
|
34 Participants
|
|
Perioperative Complications
Dindo scale Grade 1-2
|
57 Participants
|
58 Participants
|
|
Perioperative Complications
Dindo scale Grade 3
|
13 Participants
|
24 Participants
|
|
Perioperative Complications
Dindo scale Grade 5
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From day 60 after surgery till end of follow-up, up to 7 yearsPopulation: all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
The late toxicities occurring more than 60 days after surgery. These were reported using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. This scales the observed toxicity from Grade 1 to 5, assuming the following classification: * Grade 0 no event * Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. * Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. * Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. * Grade 4 Life-threatening consequences; urgent intervention indicated. * Grade 5 Death related to AE. Full AE reporting can be found in the Adverse Event Section.
Outcome measures
| Measure |
Surgery Alone
n=128 Participants
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
therapeutic conventional surgery
|
Preoperative Radiotherapy Followed by En-bloc Surgery
n=127 Participants
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
therapeutic conventional surgery
3-dimensional conformal radiation therapy
|
|---|---|---|
|
Late Complications
CTCAE Grade 0
|
58 Participants
|
53 Participants
|
|
Late Complications
CTCAE Grade 1-2
|
51 Participants
|
50 Participants
|
|
Late Complications
CTCAE Grade 3
|
17 Participants
|
20 Participants
|
|
Late Complications
CTCAE Grade 4
|
2 Participants
|
4 Participants
|
|
Late Complications
CTCAE Grade 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Two weeks after completion of Pre-operative Radiotherapy, before SurgeryPopulation: Tumor response using RECIST 1.1 was only assessed for patients receiving preoperative radiotherapy.
For patients that received preoperative radiotherapy, the tumor response was assessed using RECIST 1.1. Response criteria were essentially based on a set of measurable lesions identified at baseline as target lesions, and followed at the end of the radiotherapy. Response was not the primary endpoint, so a confirmatory CT-scan was not mandatory.
Outcome measures
| Measure |
Surgery Alone
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
therapeutic conventional surgery
|
Preoperative Radiotherapy Followed by En-bloc Surgery
n=133 Participants
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
therapeutic conventional surgery
3-dimensional conformal radiation therapy
|
|---|---|---|
|
Tumor Response to Preoperative Radiotherapy
Partial response
|
—
|
4 Participants
|
|
Tumor Response to Preoperative Radiotherapy
Stable disease
|
—
|
99 Participants
|
|
Tumor Response to Preoperative Radiotherapy
Progressive disease
|
—
|
18 Participants
|
|
Tumor Response to Preoperative Radiotherapy
Early death
|
—
|
1 Participants
|
|
Tumor Response to Preoperative Radiotherapy
Not evaluable
|
—
|
11 Participants
|
SECONDARY outcome
Timeframe: ARFI was measured from the date of randomization to the date of abdominal relapse, up to a maximum of 7 yearsPopulation: Note that distant metastasis before or in the absence of abdominal recurrence was counted as a competing risk for this endpoint - whereas distant metastasis in the absence of abdominal recurrence was considered a non-event for the primary endpoint (ARFS). This explains the difference in non-events between the survival and interval endpoint.
Abdominal recurrence was defined in the ARFS section. The following are considered competing events: * death in the absence of abdominal failure * distant metastases diagnosed before abdominal failure Patients without one of these events were censored at the date of last follow-up.
Outcome measures
| Measure |
Surgery Alone
n=133 Participants
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
therapeutic conventional surgery
|
Preoperative Radiotherapy Followed by En-bloc Surgery
n=133 Participants
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
therapeutic conventional surgery
3-dimensional conformal radiation therapy
|
|---|---|---|
|
Number of Patients With an Abdominal Recurrence
Abdominal recurrence
|
46 Participants
|
48 Participants
|
|
Number of Patients With an Abdominal Recurrence
No event (censored)
|
61 Participants
|
65 Participants
|
|
Number of Patients With an Abdominal Recurrence
Competing event (see outcome measure description)
|
26 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Metastases free survival was measured from the date of randomization to the date of occurrence of distant metastases or death, whichever occurred first, up to a maximum of 7 years.Alive and metastases free patients will be censored at the date of last follow-up.
Outcome measures
| Measure |
Surgery Alone
n=133 Participants
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
therapeutic conventional surgery
|
Preoperative Radiotherapy Followed by En-bloc Surgery
n=133 Participants
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
therapeutic conventional surgery
3-dimensional conformal radiation therapy
|
|---|---|---|
|
Number of Patients With Metastases or Death
Alive and metastases free (censored)
|
88 Participants
|
92 Participants
|
|
Number of Patients With Metastases or Death
metastasis and/or death (event)
|
45 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Overall survival was measured from the date of randomization to the date of death, whatever the cause, up to a maximum of 7 yearsAlive patients were censored at the date of last follow-up. Causes of death were recorded and reported as a table.
Outcome measures
| Measure |
Surgery Alone
n=133 Participants
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
therapeutic conventional surgery
|
Preoperative Radiotherapy Followed by En-bloc Surgery
n=133 Participants
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
therapeutic conventional surgery
3-dimensional conformal radiation therapy
|
|---|---|---|
|
Number of Patients Alive
Alive (censored)
|
111 Participants
|
108 Participants
|
|
Number of Patients Alive
Death (event)
|
22 Participants
|
25 Participants
|
Adverse Events
Surgery Alone
Serious events: 37 serious events
Other events: 124 other events
Deaths: 22 deaths
Preoperative Radiotherapy Followed by En-bloc Surgery
Serious events: 48 serious events
Other events: 127 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Surgery Alone
n=128 participants at risk
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
therapeutic conventional surgery
|
Preoperative Radiotherapy Followed by En-bloc Surgery
n=127 participants at risk
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
therapeutic conventional surgery
3-dimensional conformal radiation therapy
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Cardiac disorders
TACHYCARDIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
ABDOMINAL ADHESIONS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
DIAPHRAGMATIC HERNIA, OBSTRUCTIVE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
DUODENAL OBSTRUCTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
ENTEROCUTANEOUS FISTULA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GASTRIC FISTULA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GASTROINTESTINAL HYPOMOTILITY
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GASTROINTESTINAL MOTILITY DISORDER
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GASTROPLEURAL FISTULA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
INTRA-ABDOMINAL FLUID COLLECTION
|
3.9%
5/128 • Number of events 6 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.9%
5/127 • Number of events 6 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
JEJUNAL STENOSIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
PANCREATIC FISTULA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
PANCREATITIS NECROTISING
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMORRHAGE
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
SUBILEUS
|
3.9%
5/128 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
ASTHENIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
ULCER
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
ABDOMINAL INFECTION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
ABSCESS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
BACTERAEMIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
DEVICE OCCLUSION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
EMPYEMA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
GENITAL HERPES
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INTERVERTEBRAL DISCITIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
PANCREATIC ABSCESS
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
PERITONITIS
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
RETROPERITONEAL ABSCESS
|
2.3%
3/128 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
RETROPERITONEAL INFECTION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
SEPSIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC HAEMORRHAGE
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC LEAK
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL ANASTOMOTIC LEAK
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA, OBSTRUCTIVE
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
PANCREATIC LEAK
|
1.6%
2/128 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
PERIPANCREATIC FLUID COLLECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE ILEUS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.1%
4/127 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
ISCHAEMIC CEREBRAL INFARCTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
SPINAL CORD INFARCTION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Reproductive system and breast disorders
PELVIC FLUID COLLECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.1%
4/127 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Surgical and medical procedures
LARGE INTESTINE ANASTOMOSIS
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
HAEMATOMA
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
HAEMORRHAGE
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
ISCHAEMIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
LYMPHOCELE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
LYMPHORRHOEA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
NECROSIS ISCHAEMIC
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
Other adverse events
| Measure |
Surgery Alone
n=128 participants at risk
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
therapeutic conventional surgery
|
Preoperative Radiotherapy Followed by En-bloc Surgery
n=127 participants at risk
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
therapeutic conventional surgery
3-dimensional conformal radiation therapy
|
|---|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.1%
4/127 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Cardiac disorders
CAR OTH ARRHYTHMIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Cardiac disorders
CAR OTH TACHYCARDIA, PT ON CHEMOTHERAPY, NOT RELATED TO PRIMARY DISEASE TX
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Ear and labyrinth disorders
HEARING IMPAIRED
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Endocrine disorders
END OTH PRECOCIOUS POSTMENOPAUSALITY
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Endocrine disorders
END OTH THYMIC HYPERPLASIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Eye disorders
BLURRED VISION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Eye disorders
EYE OTH AMAUROSIS FUGAX
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Eye disorders
EYE OTH CONJUNCTIVAL PALLOR
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Eye disorders
EYE OTH DIFFICULTY TO OPEN THE LEFT EYELID
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
14.8%
19/128 • Number of events 36 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
28.3%
36/127 • Number of events 74 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
ANAL HEMORRHAGE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
BLOATING
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
BURN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
COLONIC FISTULA
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
COLONIC PERFORATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
CONSTIPATION
|
8.6%
11/128 • Number of events 19 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
31.5%
40/127 • Number of events 83 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
DIARRHEA
|
13.3%
17/128 • Number of events 29 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
46.5%
59/127 • Number of events 143 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
DUODENAL OBSTRUCTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
6.3%
8/127 • Number of events 10 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
FLATULENCE
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.1%
4/127 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH ABDOMINAL CRAMPS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH ABDOMINAL METEORISM
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH ABSCESS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH ACCELERATION OF TRANSIT
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH BELCHING
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH BOWEL OBSTRUCTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH COLON HERNIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH DENTAL PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH DIGESIVE TROUBLE (IMPERIOSITY)
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH DIGESTIVE INTOLERANCE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH DIGESTIVE TRANSIT
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH DIGESTIVE TROUBLE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH DIVERTICULITIS (MILD SYMPTOMS BUT NOT VISIBLE ON SCAN)
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH ENTERO-CUTANEOUS FISTULA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH ENTEROCUTANEOUS FISTULA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH EPIGASTRIC PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH EXCACERBATION CROHN'S DISEASE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH FISTULOUS ORIFICE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH GASTRIC DISORDERS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH GASTRIC PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH GASTROINTESTINAL DISORDERS (INTOLERANACE)
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH HEMATEMESIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH ILEAL ADHESIONS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH INCREASED URGENCY OF DEFECATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH INFECTED RETROPERITONEAL FLUID COLLECTION
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH INTESTINAL HYPOMOTILITY
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH IVER COLIC
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH LEFT RETROPERITONEAL COLLECTION, POSSIBLE PANCREATIC LEAK
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH LOWER ABDOMINAL HEAVINESS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH MALNUTRIRION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH OBSTIPATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH PAIN AT RIGHT HYPOCHONDRE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH PAIN AT RIGHT HYPOCONDRE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH POSTPRANDIAL PAIN
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH RETROPERITONEAL ABSCESS
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH SENSITIVE ABDOMEN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH SUB-OCCLUSION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH SUB-OCCLUSIVE SYNDROME
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH SUBOCLUSIVE SYNDROME
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH SWELLING LEFT LOWER ABDOMEN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH TRANSIT DISORDERS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH TRANSIT TROUBLES
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GAS OTH VAGUE ABDOMINAL COMPLAINTS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GASTRIC HEMORRHAGE
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GASTRITIS
|
1.6%
2/128 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
5.5%
7/127 • Number of events 15 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
GASTROPARESIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
ILEAL STENOSIS
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
JEJUNAL STENOSIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
NAUSEA
|
7.8%
10/128 • Number of events 15 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
72.4%
92/127 • Number of events 333 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
PANCREATIC FISTULA
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
RECTAL FISTULA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
RECTAL HEMORRHAGE
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
SMALL INTESTINAL STENOSIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
STOMACH PAIN
|
1.6%
2/128 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HEMORRHAGE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Gastrointestinal disorders
VOMITING
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
22.8%
29/127 • Number of events 64 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
CHILLS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
EDEMA FACE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
EDEMA LIMBS
|
3.9%
5/128 • Number of events 9 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
9.4%
12/127 • Number of events 50 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
EDEMA TRUNK
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 6 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
FATIGUE
|
19.5%
25/128 • Number of events 41 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
71.7%
91/127 • Number of events 394 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
FEVER
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
4.7%
6/127 • Number of events 7 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
FLU LIKE SYMPTOMS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
GEN OTH ALTERATION OF THE GENERAL STATE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
GEN OTH DISCRETE ACCELERATION OF TRANSIT
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
GEN OTH GENERAL STATUS IMPAIRMENT
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
GEN OTH NIGHT SWEATS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
GEN OTH RADIATION PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
GEN OTH RIGHT SUB PUBIC PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
GEN OTH RIGHT SUS PUBIC PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
GEN OTH TRANSIT DISORDERS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
GEN OTH WORSENING IN GENERAL CONDITION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
LOCALIZED EDEMA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
NECK PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
General disorders
PAIN
|
9.4%
12/128 • Number of events 15 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
12.6%
16/127 • Number of events 50 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Immune system disorders
ALLERGIC REACTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
ABDOMINAL INFECTION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
BONE INFECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
BRONCHIAL INFECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
CATHETER RELATED INFECTION
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH BLOOD INFECTION WITH STAPHYLOCOCCUS EPIDERMIS
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH CHEST INFECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH CLOSTRIDIUM DIFFICILE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH FUNGEMIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH HELICOBACTER PYLORI INFECTION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH HERPES GENITALIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH HERPES ZOSTER
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH HERPES ZOSTER IN RIGHT LUMBAR REGION ALMOST RESOLVED.
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH HERPES ZOSTER IN RIGHT LUMBAR REGION.
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH HSV-1 IN GENITAL AREA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH INFECTED ABDOMINAL COLLECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH INFECTED POST-OPERATIVE COLLECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH SURGICAL BED INFECTIOUS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH UNSPECIFIC INFECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
INF OTH ZONA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
PAPULOPUSTULAR RASH
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
SEPSIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
SINUSITIS
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
SKIN INFECTION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.9%
5/128 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
4.7%
6/127 • Number of events 7 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
BURN
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
DERMATITIS RADIATION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
23.6%
30/127 • Number of events 63 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
INJ OTH DIAFRAGMATIC HERNIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
INJ OTH EVENTRATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
INJ OTH EVENTRATION SURGERY
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
INJ OTH INCISIONAL HERNIA
|
3.1%
4/128 • Number of events 11 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
INJ OTH INTESTINAL ADHESIONS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
INJ OTH LEFT INGUINAL HERNIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
INJ OTH RETROPERITONEAL FLUID COLLECTION (NEGATIVE FOR INFECTION)
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
INJ OTH RIGHT INGUINAL HERNIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
INJ OTH SMALL RETROPERITONEAL COLLECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
INJ OTH SURGERY WOUND SENSITIVE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
INJ OTH WOUND PAIN (INTERMITTENT)
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
INJ OTH WOUND SURGERY PAINFUL
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
2.3%
3/128 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
3.9%
5/128 • Number of events 10 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.9%
5/127 • Number of events 10 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Investigations
CPK INCREASED
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Investigations
CREATININE INCREASED
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Investigations
INR INCREASED
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Investigations
INV OTH DECREASED IRON
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Investigations
INV OTH INFLAMMATORY SYNDROME
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Investigations
INV OTH LDH INCREASED
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Investigations
INV OTH URINE OUTPUT INCREASED
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Investigations
WEIGHT GAIN
|
3.9%
5/128 • Number of events 20 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.1%
4/127 • Number of events 7 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Investigations
WEIGHT LOSS
|
18.0%
23/128 • Number of events 41 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
49.6%
63/127 • Number of events 160 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
ANOREXIA
|
8.6%
11/128 • Number of events 14 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
48.0%
61/127 • Number of events 160 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
0.78%
1/128 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.9%
5/127 • Number of events 6 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPERMAGNESEMIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 6 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
1.6%
2/128 • Number of events 7 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Metabolism and nutrition disorders
MET OTH MALNUTRITION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
2.3%
3/128 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.1%
4/128 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
14.2%
18/127 • Number of events 30 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
2.3%
3/128 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
9.4%
12/127 • Number of events 25 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH ARTICULAR PAIN AT LEFT SHOULDER
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH DORSAL ARTHROSIS
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH INGUINAL HERNIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH INGUINLA HERNIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH LEFT ILIAC FOSSA ABSCESS
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH LEFT LIMB MUSUCLAR DEFICIT
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH LEFT SHOULDER PAIN
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH LUMBAR FOSSA MUSCULAR CRAMPS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH MASTICATION PROBLEM
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH MUSCLE CRAMPS LEGS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH MUSCULAR CRAMPS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH PAIN (LUMBAR REGION)
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH PAIN AND MUSCLE CRAMPS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH PAIN AND MUSCLES CRAMPS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH PAIN AT THE LEFT LEG
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH PAIN AT THE LEFT LUMBAR FOSSA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH PAIN AT THIGH
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH PARAVERTEBRAL PAIN
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH RIGHT INGUINAL HERNIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH RIGHT LUMBAR FOSSA PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH RIGHT PARAVERTEBRAL PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH RIGHT SHOULDER AND RIGHT SIRLOIN PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH SHOULDER PAIN
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH SHOULDER PAIN (LEFT)
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH SURGERY WOUND SENSATIVE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH TENDON RUPTURE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUS OTH TRUNK PAIN
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS TRUNK
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
3.9%
5/128 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
3.1%
4/128 • Number of events 6 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.9%
5/127 • Number of events 7 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Musculoskeletal and connective tissue disorders
SCOLIOSIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEO OTH GASTRIC POLYP
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOR PAIN
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.9%
5/127 • Number of events 9 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
DIZZINESS
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
DYSESTHESIA
|
2.3%
3/128 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.1%
4/127 • Number of events 7 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
4.7%
6/127 • Number of events 8 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
HEADACHE
|
3.9%
5/128 • Number of events 7 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
11.0%
14/127 • Number of events 26 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
ISCHEMIA CEREBROVASCULAR
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH CRURALGIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH DEAFFERENTATION PAIN
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH HYPERSENSITIVITY OF THE EXTERNAL FACE OF THE RIGHT THIGH
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH INSENSIBILITY PART RIGHT HIP
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH ISCHEMIC INFARCTION BRAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH L5 DISTAL DEFICIT
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH LEFT GROIN/THIGH NUMBNESS
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH LEG NUMBNESS (LEFT)
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH LEG NUMBNESS (LEG)
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH NEUROGENIC PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH NEUROPATHIC PAIN
|
0.78%
1/128 • Number of events 6 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH NUMBNESS (LEFT THIGH)
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH NUMBNESS LEFT LEG
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH NUMBNESS LEFT THIGH
|
0.78%
1/128 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH NUMBNESS RIGHT LEG
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH PARAPLEGIA
|
0.78%
1/128 • Number of events 7 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH RIGHT BIG TOE HYPOESTHESIA
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH RIGHT SCIATICA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH SENSITIVITY TO THE LOWER PART OF THE STERNUM
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH SENSORY DEFICIT AT THE ANTERIOR FACE OF THE LEFT THIGH
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH SEQUELAE AFTER ISCHEMIC INFARCTION BRAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NER OTH SPONGY FEELING LEFT FOSSA ILIACA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
PARESTHESIA
|
4.7%
6/128 • Number of events 16 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.9%
5/127 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
4.7%
6/128 • Number of events 13 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 6 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
10.9%
14/128 • Number of events 30 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
11.8%
15/127 • Number of events 24 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
STROKE
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
TREMOR
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Nervous system disorders
VASOVAGAL REACTION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Psychiatric disorders
ANXIETY
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.1%
4/127 • Number of events 7 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Psychiatric disorders
CONFUSION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Psychiatric disorders
DEPRESSION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.1%
4/127 • Number of events 6 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
2.4%
3/127 • Number of events 6 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Psychiatric disorders
PSY OTH SLEEP DISORDERS
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Psychiatric disorders
PSY OTH SOCIAL PHOBIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
ADRENAL INSUFFICIENCY
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
BLADDER SPASM
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
2.3%
3/128 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
HEMATURIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
REN OTH ACUTE RENAL FAILURE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
REN OTH BASELINE URINARY SYMPTOMS, OTHER.
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
REN OTH BLADDER LITHIASIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
REN OTH BLOCKED URINARY CATHETER
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
REN OTH DYSURIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
REN OTH HYDRONEPHROSIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
REN OTH INGUINAL HERNIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
REN OTH POLLAKIURIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
REN OTH RENAL FAILURE
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
REN OTH RENAL INSUFFICIENCY
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
REN OTH SYNDROME OF JUNCTION OF THE LEFT KIDNEY
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
REN OTH URINARY DISORDERS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
RENAL COLIC
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.9%
5/127 • Number of events 9 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
2.3%
3/128 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Renal and urinary disorders
URINARY URGENCY
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Reproductive system and breast disorders
EJACULATION DISORDER
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
1.6%
2/128 • Number of events 8 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Reproductive system and breast disorders
GENITAL EDEMA
|
2.3%
3/128 • Number of events 7 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Reproductive system and breast disorders
GYNECOMASTIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Reproductive system and breast disorders
PREMATURE MENOPAUSE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Reproductive system and breast disorders
REP OTH HYDROCELE
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Reproductive system and breast disorders
REP OTH RIGHT SIDE VARICOCELE
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Reproductive system and breast disorders
REP OTH TESTICULAR OEDEMA (LEFT)
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Reproductive system and breast disorders
SCROTAL PAIN
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Reproductive system and breast disorders
TESTICULAR PAIN
|
1.6%
2/128 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL OBSTRUCTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.3%
3/128 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.9%
5/127 • Number of events 7 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
3.1%
4/128 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
7.1%
9/127 • Number of events 13 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
0.78%
1/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.9%
5/127 • Number of events 6 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RES OTH BIBASAL INSPIRATORY CRACKLES
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RES OTH BREATHLESSNESS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RES OTH BRONCHITIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RES OTH COPD
|
0.78%
1/128 • Number of events 3 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RES OTH EMPYEMA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RES OTH PNEUMONIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RES OTH PULMONARY EMPHYSEMA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RES OTH RHINORRHEA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RES OTH RIGNT POSTERIOR PARIETAL PAIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RES OTH SHORTNESS OF BREATH, PT ON CHEMO, NOT RELATED TO PRIMARY DISEASE TX
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RES OTH THORACIC PAIN
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNEA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
1.6%
2/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Respiratory, thoracic and mediastinal disorders
VOICE ALTERATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.1%
4/127 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
4.7%
6/127 • Number of events 6 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
SKI OTH EPITHELITIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
SKI OTH CUTANEOUS ERUPTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
SKI OTH HYPERSENSITIVITY SCAR
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
SKI OTH ITCHING AREA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
SKI OTH KELOID SCAR
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
SKI OTH PSORIASIS
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
SKI OTH RASH
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
SKI OTH SCAR HYPERTROPHIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
SKI OTH SKIN AND SUBCUTANEOUS TISSUE (FOLLICULITIS)
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
SKI OTH SKIN IRRITATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
SKI OTH TOXICODERMIA
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
SKIN INFECTION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Skin and subcutaneous tissue disorders
SKIN ULCERATION
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
HEMATOMA
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
HOT FLASHES
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
HYPERTENSION
|
7.8%
10/128 • Number of events 24 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
7.9%
10/127 • Number of events 30 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
HYPOTENSION
|
3.1%
4/128 • Number of events 4 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
3.9%
5/127 • Number of events 9 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
SUPERFICIAL THROMBOPHLEBITIS
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
1.6%
2/128 • Number of events 2 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
5.5%
7/127 • Number of events 24 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
VAS OTH AORTIC ECTASIA
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
VAS OTH INFERIOR VENA CAVA SYNDROME
|
0.00%
0/128 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.79%
1/127 • Number of events 9 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
VAS OTH PULMONARY EMBOLISM
|
0.78%
1/128 • Number of events 5 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
|
Vascular disorders
VASCULITIS
|
0.78%
1/128 • Number of events 1 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
0.00%
0/127 • Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
|
Additional Information
EORTC HEADQUARTERS
EORTC (European Organisation for Research and Treatment of Cancer)
Phone: +32 2 774 16 11
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place