Trial Outcomes & Findings for Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (NCT NCT01107626)
NCT ID: NCT01107626
Last Updated: 2023-07-07
Results Overview
Overall survival is defined as the time from randomization to death or date last known alive. The primary analysis is among patients who were randomized to the maintenance therapy. Patients who received induction therapy only and did not participate in the randomization part of the study were not included in this analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1516 participants
Primary outcome timeframe
Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5
Results posted on
2023-07-07
Participant Flow
A total of 1,516 patients were enrolled in the study between August 2010 and April 2015. The first patient was accrued on October 25, 2010.
Participant milestones
| Measure |
Induction Therapy But Not Randomized to Maintenance Therapy
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Arm A (Induction Then Maintenance With Bevacizumab)
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm B (Induction Then Maintenance With Pemetrexed
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm C (Induction Then Maintenance With Bevacizumab and Pemetrexed)
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab IV over 30-90 minutes and pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Step 1: Induction Therapy
STARTED
|
642
|
287
|
294
|
293
|
|
Step 1: Induction Therapy
COMPLETED
|
65
|
287
|
294
|
293
|
|
Step 1: Induction Therapy
NOT COMPLETED
|
577
|
0
|
0
|
0
|
|
Step 2: Maintenance Therapy
STARTED
|
0
|
287
|
294
|
293
|
|
Step 2: Maintenance Therapy
COMPLETED
|
0
|
1
|
0
|
1
|
|
Step 2: Maintenance Therapy
NOT COMPLETED
|
0
|
286
|
294
|
292
|
Reasons for withdrawal
| Measure |
Induction Therapy But Not Randomized to Maintenance Therapy
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Arm A (Induction Then Maintenance With Bevacizumab)
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm B (Induction Then Maintenance With Pemetrexed
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm C (Induction Then Maintenance With Bevacizumab and Pemetrexed)
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab IV over 30-90 minutes and pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Step 1: Induction Therapy
Lack of Efficacy
|
167
|
0
|
0
|
0
|
|
Step 1: Induction Therapy
Adverse Event
|
198
|
0
|
0
|
0
|
|
Step 1: Induction Therapy
Death
|
62
|
0
|
0
|
0
|
|
Step 1: Induction Therapy
Withdrawal by Subject
|
54
|
0
|
0
|
0
|
|
Step 1: Induction Therapy
Complicating disease
|
13
|
0
|
0
|
0
|
|
Step 1: Induction Therapy
Alternative therapy
|
12
|
0
|
0
|
0
|
|
Step 1: Induction Therapy
Symptomatic deterioration
|
10
|
0
|
0
|
0
|
|
Step 1: Induction Therapy
Non-compliance
|
4
|
0
|
0
|
0
|
|
Step 1: Induction Therapy
Pain
|
4
|
0
|
0
|
0
|
|
Step 1: Induction Therapy
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Step 1: Induction Therapy
Hospice care
|
1
|
0
|
0
|
0
|
|
Step 1: Induction Therapy
Physician Decision
|
1
|
0
|
0
|
0
|
|
Step 1: Induction Therapy
Off treatment reason not reported
|
50
|
0
|
0
|
0
|
|
Step 2: Maintenance Therapy
Lack of Efficacy
|
0
|
217
|
217
|
170
|
|
Step 2: Maintenance Therapy
Adverse Event
|
0
|
32
|
29
|
46
|
|
Step 2: Maintenance Therapy
Death
|
0
|
8
|
2
|
13
|
|
Step 2: Maintenance Therapy
Withdrawal by Subject
|
0
|
11
|
21
|
27
|
|
Step 2: Maintenance Therapy
Alternative therapy
|
0
|
2
|
4
|
5
|
|
Step 2: Maintenance Therapy
Other complicating disease
|
0
|
2
|
5
|
9
|
|
Step 2: Maintenance Therapy
Symptomatic deterioration
|
0
|
2
|
4
|
3
|
|
Step 2: Maintenance Therapy
Exceeded maximum delay in treatment
|
0
|
2
|
2
|
3
|
|
Step 2: Maintenance Therapy
Diagnosis of progressive disease error
|
0
|
1
|
1
|
0
|
|
Step 2: Maintenance Therapy
Financial reason
|
0
|
2
|
0
|
0
|
|
Step 2: Maintenance Therapy
Physician Decision
|
0
|
2
|
3
|
3
|
|
Step 2: Maintenance Therapy
Hospice care
|
0
|
1
|
2
|
0
|
|
Step 2: Maintenance Therapy
Non-compliance
|
0
|
0
|
0
|
2
|
|
Step 2: Maintenance Therapy
Pain
|
0
|
0
|
0
|
1
|
|
Step 2: Maintenance Therapy
Off treatment reason not reported
|
0
|
4
|
4
|
10
|
Baseline Characteristics
Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Induction Therapy But Not Randomized
n=642 Participants
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Arm A (Induction Then Maintenance With Bevacizumab)
n=287 Participants
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm B (Induction Then Maintenance With Pemetrexed)
n=294 Participants
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm C (Inductio Then Maintenance With Bevacizumab & Pemetrexed)
n=293 Participants
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab IV over 30-90 minutes and pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Total
n=1516 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
65 years
n=7 Participants
|
63 years
n=5 Participants
|
64 years
n=4 Participants
|
64 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
276 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
724 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
366 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
792 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
82 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
180 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
528 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
260 Participants
n=4 Participants
|
1273 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5Population: All randomized patients
Overall survival is defined as the time from randomization to death or date last known alive. The primary analysis is among patients who were randomized to the maintenance therapy. Patients who received induction therapy only and did not participate in the randomization part of the study were not included in this analysis.
Outcome measures
| Measure |
Arm A (Induction Then Maintenance With Bevacizumab)
n=287 Participants
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm B (Induction Then Maintenance With Pemetrexed
n=294 Participants
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm C (Induction Then Maintenance With Bevacizumab and Pemetrexed)
n=293 Participants
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab IV over 30-90 minutes and pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Survival
|
14.4 months
Interval 11.6 to 17.0
|
15.9 months
Interval 12.7 to 20.0
|
16.4 months
Interval 14.0 to 18.9
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5Population: All randomized patients
Progression-free survival is defined as the time from randomization to progression or death, whichever occurs first. Progression is evaluated based on RECIST criteria and defined as appearance of one or more new lesions, unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on current step. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The primary analysis is among patients who were randomized to the maintenance therapy. Patients who received induction therapy only and did not participate in the randomization part of the study were not included in this analysis.
Outcome measures
| Measure |
Arm A (Induction Then Maintenance With Bevacizumab)
n=287 Participants
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm B (Induction Then Maintenance With Pemetrexed
n=294 Participants
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm C (Induction Then Maintenance With Bevacizumab and Pemetrexed)
n=293 Participants
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab IV over 30-90 minutes and pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
|---|---|---|---|
|
Progression-free Survival
|
4.2 months
Interval 3.9 to 5.0
|
5.1 months
Interval 4.5 to 6.2
|
7.5 months
Interval 6.6 to 9.0
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5Population: All randomized patients
Response is evaluated based on RECIST criteria v1.1 and defined as either complete response or partial response. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the current step's baseline sum diameters. The primary analysis is among patients who were randomized to the maintenance therapy. Patients who received induction therapy only and did not participate in the randomization part of the study were not included in this analysis.
Outcome measures
| Measure |
Arm A (Induction Then Maintenance With Bevacizumab)
n=287 Participants
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm B (Induction Then Maintenance With Pemetrexed
n=294 Participants
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm C (Induction Then Maintenance With Bevacizumab and Pemetrexed)
n=293 Participants
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab IV over 30-90 minutes and pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
|---|---|---|---|
|
Response Rate
|
0.125 proportion of participants
Interval 0.085 to 0.176
|
0.187 proportion of participants
Interval 0.139 to 0.244
|
0.212 proportion of participants
Interval 0.16 to 0.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5To determine the frequency of polymorphisms in VEGF 3578 AA, 1154 AA, ABCB1 G2677TT/AA and ERCC-118 TT in patients with NSCLC receiving paclitaxel, carboplatin and bevacizumab therapy and determine the association between genotypes and response rate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 3 weeks while on treatment and for 30 days after the end of treatmentOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 3 months for 2 years and every 6 months for years 3-5Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 3 months for 2 years and every 6 months for years 3-5Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 3 months for 2 years and every 6 months for years 3-5Outcome measures
Outcome data not reported
Adverse Events
Arm I (Induction Therapy - Carboplatin, Paclitaxel & Bevacizumab)
Serious events: 825 serious events
Other events: 1178 other events
Deaths: 1290 deaths
Arm A (Maintenance Therapy - Bevacizumab)
Serious events: 87 serious events
Other events: 216 other events
Deaths: 245 deaths
Arm B (Maintenance Therapy - Pemetrexed)
Serious events: 107 serious events
Other events: 222 other events
Deaths: 240 deaths
Arm C (Maintenance Therapy - Bevacizumab + Pemetrexed)
Serious events: 144 serious events
Other events: 237 other events
Deaths: 236 deaths
Serious adverse events
| Measure |
Arm I (Induction Therapy - Carboplatin, Paclitaxel & Bevacizumab)
n=1477 participants at risk
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Arm A (Maintenance Therapy - Bevacizumab)
n=284 participants at risk
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm B (Maintenance Therapy - Pemetrexed)
n=289 participants at risk
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm C (Maintenance Therapy - Bevacizumab + Pemetrexed)
n=286 participants at risk
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab IV over 30-90 minutes and pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.54%
8/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.34%
5/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.1%
16/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.70%
2/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.69%
2/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.0%
3/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
53/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.8%
5/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.7%
5/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
4.2%
12/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
91/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.1%
6/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
6.9%
20/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
6.6%
19/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.5%
52/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.4%
4/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Asystole
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Cardiac arrest
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Heart failure
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Myocardial infarction
|
0.27%
4/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Pericardial effusion
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Sinus tachycardia
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Chills
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Death NOS
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Edema face
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Edema limbs
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Facial pain
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Fatigue
|
7.9%
116/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.8%
8/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
7.6%
22/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
8.4%
24/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Fever
|
0.41%
6/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Flu like symptoms
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Gait disturbance
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Hypothermia
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Infusion related reaction
|
0.54%
8/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Infusion site extravasation
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Non-cardiac chest pain
|
0.27%
4/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Pain
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Sudden death NOS
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
General and administration site - Other
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.47%
7/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue - Other
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.41%
6/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.0%
3/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Colitis
|
0.47%
7/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.54%
8/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Constipation
|
0.47%
7/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
32/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.7%
5/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.7%
5/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Dysphagia
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Esophageal fistula
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Esophageal perforation
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Esophagitis
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Gastritis
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Mucositis oral
|
1.0%
15/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.4%
4/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
58/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.69%
2/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.4%
7/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Rectal fistula
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
37/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.1%
6/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Immune system disorders
Allergic reaction
|
0.41%
6/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Immune system disorders
Anaphylaxis
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Abdominal infection
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Anorectal infection
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Catheter related infection
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Device related infection
|
0.27%
4/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Duodenal infection
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Enterocolitis infectious
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Esophageal infection
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Lung infection
|
1.6%
24/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.1%
6/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.1%
6/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Mucosal infection
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Pelvic infection
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Sepsis
|
0.95%
14/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.0%
3/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Skin infection
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.0%
3/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Small intestine infection
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.70%
2/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Upper respiratory infection
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Urinary tract infection
|
0.34%
5/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.69%
2/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.0%
3/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Infections and infestations
Infections and infestations - Other
|
0.27%
4/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.69%
2/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Injury, poisoning and procedural complications
Fall
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Alanine aminotransferase increased
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Aspartate aminotransferase increased
|
0.27%
4/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.69%
2/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.70%
2/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Cardiac troponin I increased
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Cardiac troponin T increased
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Creatinine increased
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.4%
4/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Ejection fraction decreased
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
INR increased
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Lymphocyte count decreased
|
4.3%
64/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.1%
3/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.5%
16/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
8.0%
23/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Neutrophil count decreased
|
27.3%
403/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.1%
3/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
8.0%
23/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
11.2%
32/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Platelet count decreased
|
7.4%
109/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.8%
11/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
4.2%
12/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Weight gain
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.69%
2/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Weight loss
|
0.27%
4/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.4%
7/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
White blood cell decreased
|
14.4%
213/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.2%
15/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
4.9%
14/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.2%
48/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.70%
2/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.7%
5/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.0%
3/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
42/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.7%
5/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.8%
8/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.1%
16/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.70%
2/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.54%
8/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
15/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.0%
3/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.9%
28/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.69%
2/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.4%
4/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.69%
2/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
17/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.27%
4/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.70%
2/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Cognitive disturbance
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Concentration impairment
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Dizziness
|
0.34%
5/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Encephalopathy
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Headache
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.70%
2/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Memory impairment
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.41%
6/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.70%
2/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.0%
30/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.4%
4/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.4%
7/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Syncope
|
0.68%
10/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.70%
2/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other
|
0.27%
4/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Psychiatric disorders
Confusion
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Psychiatric disorders
Delirium
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Psychiatric disorders
Depression
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Psychiatric disorders
Insomnia
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.34%
5/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.70%
2/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
21/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.70%
2/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.7%
5/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.4%
7/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.69%
2/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.4%
4/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.20%
3/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.54%
8/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory thoracic mediastinal - Other
|
0.47%
7/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Renal and urinary disorders
Hematuria
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Renal and urinary disorders
Proteinuria
|
0.54%
8/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
4.2%
12/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.8%
8/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Vascular disorders
Hypertension
|
10.9%
161/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
16.5%
47/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
4.5%
13/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
18.9%
54/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Vascular disorders
Hypotension
|
1.0%
15/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.70%
2/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Vascular disorders
Thromboembolic event
|
3.1%
46/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.8%
5/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.4%
4/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Vascular disorders
Visceral arterial ischemia
|
0.07%
1/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.14%
2/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.35%
1/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
Other adverse events
| Measure |
Arm I (Induction Therapy - Carboplatin, Paclitaxel & Bevacizumab)
n=1477 participants at risk
Induction Therapy:
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Arm A (Maintenance Therapy - Bevacizumab)
n=284 participants at risk
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm B (Maintenance Therapy - Pemetrexed)
n=289 participants at risk
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
Arm C (Maintenance Therapy - Bevacizumab + Pemetrexed)
n=286 participants at risk
Maintenance Therapy:
Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab IV over 30-90 minutes and pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
9.7%
144/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.5%
10/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
11.4%
33/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
12.6%
36/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
General disorders
Fatigue
|
35.7%
528/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
27.8%
79/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
40.8%
118/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
43.7%
125/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
51.3%
758/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
39.8%
113/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
39.8%
115/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
40.2%
115/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
113/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.5%
10/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.2%
15/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
9.4%
27/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
6.8%
101/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.70%
2/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.2%
15/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
4.9%
14/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.1%
3/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.4%
7/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.9%
17/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Nausea
|
15.9%
235/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
6.3%
18/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
12.8%
37/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
18.2%
52/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Gastrointestinal disorders
Vomiting
|
6.3%
93/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
1.1%
3/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
4.8%
14/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
7.3%
21/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Creatinine increased
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.8%
8/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.9%
17/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Lymphocyte count decreased
|
5.3%
78/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
2.1%
6/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
11.4%
33/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
10.5%
30/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Platelet count decreased
|
6.3%
93/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
Weight loss
|
5.8%
86/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
7.0%
20/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.9%
17/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
9.8%
28/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Investigations
White blood cell decreased
|
5.8%
86/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Anorexia
|
19.9%
294/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
11.6%
33/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
18.7%
54/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
21.7%
62/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
83/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.00%
0/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.5%
10/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.1%
9/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.9%
17/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.6%
201/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.9%
11/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
6.2%
18/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.6%
16/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.0%
162/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
4.6%
13/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
4.8%
14/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
5.6%
16/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Dysgeusia
|
7.0%
103/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
3.5%
10/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
6.6%
19/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
6.6%
19/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.9%
206/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
14.4%
41/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
15.2%
44/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
17.5%
50/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.6%
98/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
4.9%
14/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
8.0%
23/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
12.6%
36/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
14.4%
41/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
0.69%
2/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
13.6%
39/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
|
Vascular disorders
Hypertension
|
17.9%
265/1477 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
30.6%
87/284 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
17.0%
49/289 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
38.8%
111/286 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60