Trial Outcomes & Findings for Efficacy And Safety Of Xeliri + Avastin Followed By Xelox + Avastin Or Reverse Sequence In Metastatic Colorectal Cancer (NCT NCT02119026)
NCT ID: NCT02119026
Last Updated: 2019-09-25
Results Overview
The primary variable was duration of disease control (DDC) and was defined as the sum of progression free survival intervals during first line and second line treatment (= time from the beginning of first line treatment until onset of progression during second line treatment). Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval - in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
screening, every 8 to 9 weeks until progression, at end of treatment (other than progression), every 3 months until progression, death or up to 24 months (whatever comes first)
Results posted on
2019-09-25
Participant Flow
Participant milestones
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
|---|---|---|
|
1st-line Treatment
STARTED
|
58
|
62
|
|
1st-line Treatment
COMPLETED
|
32
|
24
|
|
1st-line Treatment
NOT COMPLETED
|
26
|
38
|
|
2nd-line Treatment
STARTED
|
32
|
24
|
|
2nd-line Treatment
COMPLETED
|
23
|
22
|
|
2nd-line Treatment
NOT COMPLETED
|
9
|
2
|
Reasons for withdrawal
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
|---|---|---|
|
1st-line Treatment
Adverse Event
|
9
|
14
|
|
1st-line Treatment
Physician Decision
|
3
|
8
|
|
1st-line Treatment
Withdrawal by Subject
|
4
|
10
|
|
1st-line Treatment
Patient condition or compliance
|
6
|
4
|
|
1st-line Treatment
Surgery of metastases
|
2
|
1
|
|
1st-line Treatment
Death
|
2
|
1
|
|
2nd-line Treatment
Lost to Follow-up
|
2
|
0
|
|
2nd-line Treatment
Withdrawal by Subject
|
3
|
1
|
|
2nd-line Treatment
Adverse Event
|
4
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
n=58 Participants
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV)
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
n=62 Participants
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV)
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.03 years
STANDARD_DEVIATION 9.82 • n=58 Participants
|
64.06 years
STANDARD_DEVIATION 9.70 • n=62 Participants
|
64.53 years
STANDARD_DEVIATION 9.73 • n=120 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=58 Participants
|
19 Participants
n=62 Participants
|
38 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=58 Participants
|
43 Participants
n=62 Participants
|
82 Participants
n=120 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Austria
|
58 participants
n=58 Participants
|
62 participants
n=62 Participants
|
120 participants
n=120 Participants
|
PRIMARY outcome
Timeframe: screening, every 8 to 9 weeks until progression, at end of treatment (other than progression), every 3 months until progression, death or up to 24 months (whatever comes first)Population: ITT-Population
The primary variable was duration of disease control (DDC) and was defined as the sum of progression free survival intervals during first line and second line treatment (= time from the beginning of first line treatment until onset of progression during second line treatment). Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval - in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date).
Outcome measures
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
n=58 Participants
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
n=62 Participants
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
|---|---|---|
|
Efficacy Duration of Disease Control by Tumor Assessment (CT/MRI/Clinical Examination)
|
373.00 days
Interval 321.52 to 424.48
|
370.00 days
Interval 253.255 to 486.745
|
SECONDARY outcome
Timeframe: at progression of disease (PD) in first line therapy or at 28 days safety follow-up in cases without PDPopulation: ITT-Population
The first line PFS was defined as the progression free survival interval during first line treatment. Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval - in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date). Missing onset of progression data because of refusal or because of death was replaced. If several response evaluations for a patient showed progressive disease (PD), the time to PD was assessed by using the first of these measurements.
Outcome measures
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
n=58 Participants
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
n=62 Participants
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
|---|---|---|
|
First Line Progression Free Survival (PFS)
|
241 days
Interval 203.841 to 278.159
|
280 days
Interval 233.398 to 326.602
|
SECONDARY outcome
Timeframe: at progression of disease (PD) in second line therapy or at 28 days safety follow-up in cases without PDPopulation: ITT-Population after cross-over
The second line PFS was defined as the progression free survival interval during second line treatment. Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval - in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date). Missing onset of progression data because of refusal or because of death was replaced. If several response evaluations for a patient showed progressive disease (PD), the time to PD was assessed by using the first of these measurements.
Outcome measures
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
n=32 Participants
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
n=24 Participants
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
|---|---|---|
|
Second Line PFS
|
129 days
Interval 60.34 to 197.66
|
155 days
Interval 108.19 to 201.81
|
SECONDARY outcome
Timeframe: at the day of documented complete or partial response or at 28 days safety follow-up in cases without PDPopulation: ITT-Population
The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first).
Outcome measures
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
n=58 Participants
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
n=62 Participants
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
|---|---|---|
|
Overall Response Rate (Number of Participants With Response)
|
32 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: at the day of documented complete or partial response or at 28 days safety follow-up in cases without PDPopulation: ITT-Population
Time to overall response was measured from the time of randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Patients without response were censored at the date of the last tumor assessment, the date of death or the date of refusal.
Outcome measures
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
n=58 Participants
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
n=62 Participants
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
|---|---|---|
|
Time to Response
|
185.0 days
Interval 97.423 to 272.577
|
178.0 days
Interval 127.949 to 228.051
|
SECONDARY outcome
Timeframe: at the day of documented complete or partial response or at 28 days safety follow-up in cases without PDDuration of overall response was measured from the time that measurement criteria are met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the onset of progression. Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval - in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date). Missing onset of progression data because of refusal or because of death was replaced. If several response evaluations for a patient showed progressive disease (PD), the time to PD was assessed by using the first of these measurements.
Outcome measures
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
n=32 Participants
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
n=36 Participants
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
|---|---|---|
|
Duration of Response
|
244.0 days
Interval 166.888 to 321.112
|
315 days
Interval 142.297 to 487.703
|
SECONDARY outcome
Timeframe: date of death or date of last tumor assessment (28d safety f-u) in patients without deathPopulation: ITT-Population
Overall survival was measured as the time from the randomization date to the date of death. Patients without death date were censored at the date of the last tumor assessment (exception: availability of validated information about a later exitus date or a prolonged survival - in such a case the date of the follow-up assessment was either defined as the exitus date or replaced the last tumor assessment date) or the date of refusal.
Outcome measures
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
n=58 Participants
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
n=62 Participants
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
|---|---|---|
|
Overall Survival of XELIRI Plus Bevacizumab and XELOX Plus Bevacizumab
|
593.0 days
Interval 506.691 to 679.309
|
643 days
Interval 437.227 to 848.773
|
SECONDARY outcome
Timeframe: Baseline, every 8-9 weeks, 28d Safety follow-upBest response in first line was based on the tumor assessments (based on RECIST criteria) for target lesions and assessed by CT scans, MRI scans, X-ray, bone scan and clinical examination: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (sum LD) of target lesions; Progressive Disease (PD), \>= 20% increase in the sum of the LD of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
n=53 Participants
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
n=54 Participants
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
|---|---|---|
|
Tumour Assessments (Based on RECIST Criteria) in 1st-line
Progressive Disease (PD)
|
4 participants
|
1 participants
|
|
Tumour Assessments (Based on RECIST Criteria) in 1st-line
Stable Disease (SD)
|
21 participants
|
23 participants
|
|
Tumour Assessments (Based on RECIST Criteria) in 1st-line
Partial Response (PR)
|
26 participants
|
30 participants
|
|
Tumour Assessments (Based on RECIST Criteria) in 1st-line
Complete Response (CR)
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, every 8-9 weeks, 28d Safety follow-upBest response in second line was based on the tumor assessments (based on RECIST criteria) for target lesions and assessed by CT scans, MRI scans, X-ray, bone scan and clinical examination: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (sum LD) of target lesions; Progressive Disease (PD), \>= 20% increase in the sum of the LD of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
n=32 Participants
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
n=24 Participants
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
|---|---|---|
|
Tumour Assessments (Based on RECIST Criteria) in 2nd-line
Progressive Disease (PD)
|
7 participants
|
8 participants
|
|
Tumour Assessments (Based on RECIST Criteria) in 2nd-line
Stable Disease (SD)
|
11 participants
|
13 participants
|
|
Tumour Assessments (Based on RECIST Criteria) in 2nd-line
Partial Response (PR)
|
6 participants
|
2 participants
|
|
Tumour Assessments (Based on RECIST Criteria) in 2nd-line
Complete Response (CR)
|
0 participants
|
0 participants
|
|
Tumour Assessments (Based on RECIST Criteria) in 2nd-line
Not available (NA)
|
8 participants
|
1 participants
|
Adverse Events
A: XELIRI + BEV Followed by XELOX + BEV
Serious events: 43 serious events
Other events: 55 other events
Deaths: 4 deaths
B: XELOX + BEV Followed by XELIRI + BEV
Serious events: 51 serious events
Other events: 61 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
n=58 participants at risk
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
n=62 participants at risk
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
|---|---|---|
|
Vascular disorders
Circulatory collaps
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Vascular disorders
Hypertension
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Vascular disorders
Peripheral ischemia
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Surgical and medical procedures
Colectomy
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Surgical and medical procedures
Colostomy
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Surgical and medical procedures
Hepatectomy
|
10.3%
6/58 • Number of events 6 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
12.9%
8/62 • Number of events 9 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Surgical and medical procedures
Lung lobectomy
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Surgical and medical procedures
Proctectomy
|
3.4%
2/58 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
3.2%
2/62 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Surgical and medical procedures
Proctocolectomy
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Surgical and medical procedures
Pulmonary resection
|
3.4%
2/58 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Surgical and medical procedures
Salpingo-oophorectomy bilateral
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Surgical and medical procedures
Sigmoidectomy
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Surgical and medical procedures
Thermal ablation
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastates to abdominal wall
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
General disorders
Asthenia
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
General disorders
General physical health deterioration
|
3.4%
2/58 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
8.1%
5/62 • Number of events 5 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
General disorders
Malaise
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
General disorders
Pain
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
General disorders
Performance status decreased
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
General disorders
Pyrexia
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
6.5%
4/62 • Number of events 4 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
General disorders
Ulcer
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Psychiatric disorders
Confusional state
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Psychiatric disorders
Pain attack
|
1.7%
1/58 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma necrosis
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Injury, poisoning and procedural complications
Stoma site inflammation
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Investigations
Body temperature increased
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Investigations
C-reactive protein increased
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Investigations
General physical condition
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Investigations
Hepatic enzyme increased
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Investigations
Weight increased
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Cardiac disorders
Ventricular fibrillation
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Congenital, familial and genetic disorders
Intestinal atresia
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.3%
6/58 • Number of events 7 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
12.9%
8/62 • Number of events 8 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Blood and lymphatic system disorders
Aneamia
|
1.7%
1/58 • Number of events 4 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.2%
3/58 • Number of events 3 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
3.2%
2/62 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Nervous system disorders
Headache
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Nervous system disorders
Hemiplegia
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Nervous system disorders
Polyneuropathy
|
1.7%
1/58 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Nervous system disorders
Restless leg syndrome
|
1.7%
1/58 • Number of events 3 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Cardiac disorders
Cardiac arrest
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
2/58 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
4.8%
3/62 • Number of events 9 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Colitis
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Constipation
|
3.4%
2/58 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.9%
4/58 • Number of events 4 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
8.1%
5/62 • Number of events 7 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Ileus
|
3.4%
2/58 • Number of events 4 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Incarcerated inginual hernia
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
4.8%
3/62 • Number of events 3 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Subileus
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
3.2%
2/62 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Renal and urinary disorders
Bladder perforation
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Renal and urinary disorders
Renal failure
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
3.2%
2/62 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Hepatobiliary disorders
Gallbladder fistula
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Hepatobiliary disorders
Jaundice
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Abdominal abscess
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Device related infection
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Lung infection
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Peritonitis
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
3.2%
2/62 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Pneumonia
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Sepsis
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Sinusitis
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Small intestine gangrene
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Systemic infection
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
Other adverse events
| Measure |
A: XELIRI + BEV Followed by XELOX + BEV
n=58 participants at risk
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV))
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Capecitabine: 800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab: 7,5 mg/kg given on d1 q3w
Irinotecan: 200mg/m2 iv. d 1 q3w .
|
B: XELOX + BEV Followed by XELIRI + BEV
n=62 participants at risk
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV))
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Capecitabine: 1000mg/m2 bid d1-14,
Bevacizumab: 7,5 mg/kg given on d1 q3w
Oxaliplatin: 130mg/m2 iv. d 1 q3w
|
|---|---|---|
|
Vascular disorders
Hypertension
|
22.4%
13/58 • Number of events 23 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
22.6%
14/62 • Number of events 19 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
General disorders
Fatigue
|
36.2%
21/58 • Number of events 43 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
43.5%
27/62 • Number of events 63 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
General disorders
General physical health deterioration
|
6.9%
4/58 • Number of events 6 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
4.8%
3/62 • Number of events 3 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
General disorders
Mucosal inflammation
|
12.1%
7/58 • Number of events 9 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
9.7%
6/62 • Number of events 9 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
General disorders
Oedema
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
6.5%
4/62 • Number of events 8 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
General disorders
Pain
|
0.00%
0/58 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
6.5%
4/62 • Number of events 4 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
General disorders
Pyrexia
|
5.2%
3/58 • Number of events 5 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
8.1%
5/62 • Number of events 9 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Psychiatric disorders
Depression
|
5.2%
3/58 • Number of events 3 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
6.5%
4/62 • Number of events 11 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Psychiatric disorders
Insomnia
|
8.6%
5/58 • Number of events 7 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
4.8%
3/62 • Number of events 3 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Investigations
Blood pressure increased
|
5.2%
3/58 • Number of events 4 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
4.8%
3/62 • Number of events 5 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Investigations
Body temperature increased
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
6.5%
4/62 • Number of events 4 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Investigations
C-reactive protein increased
|
6.9%
4/58 • Number of events 5 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
16.1%
10/62 • Number of events 15 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Investigations
Weight decreased
|
12.1%
7/58 • Number of events 7 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
22.6%
14/62 • Number of events 19 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Blood and lymphatic system disorders
Anaemia
|
13.8%
8/58 • Number of events 14 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
11.3%
7/62 • Number of events 18 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.5%
9/58 • Number of events 22 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
8.1%
5/62 • Number of events 8 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.2%
10/58 • Number of events 15 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
4.8%
3/62 • Number of events 3 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.6%
5/58 • Number of events 5 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
8.1%
5/62 • Number of events 5 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.3%
6/58 • Number of events 7 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
8.1%
5/62 • Number of events 7 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/58 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
9.7%
6/62 • Number of events 7 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Nervous system disorders
Dysgeusia
|
10.3%
6/58 • Number of events 8 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
11.3%
7/62 • Number of events 9 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Nervous system disorders
Headache
|
12.1%
7/58 • Number of events 8 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Nervous system disorders
Neuropathy peripheral
|
10.3%
6/58 • Number of events 7 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
6.5%
4/62 • Number of events 4 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Nervous system disorders
Paraesthesia
|
8.6%
5/58 • Number of events 9 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
11.3%
7/62 • Number of events 10 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Nervous system disorders
Polyneuropathy
|
36.2%
21/58 • Number of events 32 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
59.7%
37/62 • Number of events 90 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Ear and labyrinth disorders
Vertigo
|
13.8%
8/58 • Number of events 9 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
17.7%
11/62 • Number of events 16 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Abdominal pain
|
25.9%
15/58 • Number of events 21 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
17.7%
11/62 • Number of events 15 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.3%
6/58 • Number of events 8 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
8.1%
5/62 • Number of events 10 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Constipation
|
27.6%
16/58 • Number of events 27 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
22.6%
14/62 • Number of events 18 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Diarrhoea
|
55.2%
32/58 • Number of events 64 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
38.7%
24/62 • Number of events 59 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
2/58 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
11.3%
7/62 • Number of events 8 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Nausea
|
36.2%
21/58 • Number of events 38 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
21.0%
13/62 • Number of events 37 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Stomatitis
|
5.2%
3/58 • Number of events 4 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
6.5%
4/62 • Number of events 7 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
5/58 • Number of events 6 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
12.9%
8/62 • Number of events 8 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.0%
18/58 • Number of events 25 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
8.1%
5/62 • Number of events 5 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Skin and subcutaneous tissue disorders
dry skin
|
3.4%
2/58 • Number of events 2 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
11.3%
7/62 • Number of events 11 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaestesia syndrome
|
34.5%
20/58 • Number of events 46 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
35.5%
22/62 • Number of events 53 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
3/58 • Number of events 4 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
4.8%
3/62 • Number of events 4 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
4/58 • Number of events 4 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
8.1%
5/62 • Number of events 6 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
5/58 • Number of events 5 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
1.6%
1/62 • Number of events 1 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.9%
15/58 • Number of events 26 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
17.7%
11/62 • Number of events 23 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.6%
5/58 • Number of events 7 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
19.4%
12/62 • Number of events 20 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Gastrointestinal infection
|
6.9%
4/58 • Number of events 4 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
0.00%
0/62 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Nasypharyngitis
|
8.6%
5/58 • Number of events 6 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
12.9%
8/62 • Number of events 10 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Rhinitis
|
5.2%
3/58 • Number of events 3 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
6.5%
4/62 • Number of events 7 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
|
Infections and infestations
Urinary tract infection
|
19.0%
11/58 • Number of events 13 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
8.1%
5/62 • Number of events 5 • From enrollment until 28 days of last study treatment for the individual patient. Adverse events/serious adverse events still ongoing after that timepoint were followed until last patient last visit (31-Aug-2017).
Clarification regarding threshold for reporting non-serious adverse events: if more than 5 % of patients within on reporting group were affected, non-serious adverse event was reported (more than 3 patients within Arm A and/or Arm B).
|
Additional Information
Werner Scheithauer, MD
Medical University Vienna, Internal Med. I, Dep. of Oncology
Phone: +43 1 40400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place