Trial Outcomes & Findings for S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer. (NCT NCT00127205)
NCT ID: NCT00127205
Last Updated: 2021-07-02
Results Overview
Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
6097 participants
Primary outcome timeframe
Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence
Results posted on
2021-07-02
Participant Flow
Participant milestones
| Measure |
Arm I Zoledronate
Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
zoledronic acid: Given IV
|
Arm II Clodronate
Patients receive oral clodronate once daily for 35 months.
clodronate disodium: Given orally
|
Arm III Ibandronate
Patients receive oral ibandronate once daily for 35 months.
ibandronate sodium: Given orally
|
|---|---|---|---|
|
Overall Study
STARTED
|
2262
|
2268
|
1567
|
|
Overall Study
COMPLETED
|
1433
|
1295
|
955
|
|
Overall Study
NOT COMPLETED
|
829
|
973
|
612
|
Reasons for withdrawal
| Measure |
Arm I Zoledronate
Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
zoledronic acid: Given IV
|
Arm II Clodronate
Patients receive oral clodronate once daily for 35 months.
clodronate disodium: Given orally
|
Arm III Ibandronate
Patients receive oral ibandronate once daily for 35 months.
ibandronate sodium: Given orally
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
228
|
387
|
273
|
|
Overall Study
Death
|
8
|
6
|
5
|
|
Overall Study
Withdrawal by Subject
|
318
|
310
|
172
|
|
Overall Study
Other-non protocol specified
|
142
|
129
|
77
|
|
Overall Study
Data not reported
|
6
|
10
|
1
|
|
Overall Study
Progression
|
127
|
131
|
84
|
Baseline Characteristics
S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.
Baseline characteristics by cohort
| Measure |
Arm I Zoledronate
n=2231 Participants
Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
zoledronic acid: Given IV
|
Arm II Clodronate
n=2235 Participants
Patients receive oral clodronate once daily for 35 months.
clodronate disodium: Given orally
|
Arm III Ibandronate
n=1552 Participants
Patients receive oral ibandronate once daily for 35 months.
ibandronate sodium: Given orally
|
Total
n=6018 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.0 years
n=5 Participants
|
52.6 years
n=7 Participants
|
52.7 years
n=5 Participants
|
52.7 years
n=4 Participants
|
|
Age, Customized
Age, Categorized · Age < 55
|
1270 Participants
n=5 Participants
|
1304 Participants
n=7 Participants
|
894 Participants
n=5 Participants
|
3468 Participants
n=4 Participants
|
|
Age, Customized
Age, Categorized · Age >= 55
|
961 Participants
n=5 Participants
|
931 Participants
n=7 Participants
|
658 Participants
n=5 Participants
|
2550 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2231 Participants
n=5 Participants
|
2235 Participants
n=7 Participants
|
1552 Participants
n=5 Participants
|
6018 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
70 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
217 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
129 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
332 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1975 Participants
n=5 Participants
|
1976 Participants
n=7 Participants
|
1374 Participants
n=5 Participants
|
5325 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Nodal Status
Negative
|
1089 Participants
n=5 Participants
|
1152 Participants
n=7 Participants
|
784 Participants
n=5 Participants
|
3025 Participants
n=4 Participants
|
|
Nodal Status
1~3
|
722 Participants
n=5 Participants
|
685 Participants
n=7 Participants
|
489 Participants
n=5 Participants
|
1896 Participants
n=4 Participants
|
|
Nodal Status
>=4
|
404 Participants
n=5 Participants
|
385 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
1056 Participants
n=4 Participants
|
|
ER/PR
Negative (ER-, PR-)
|
480 Participants
n=5 Participants
|
487 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
1286 Participants
n=4 Participants
|
|
ER/PR
Positive (ER+ or PR+)
|
1747 Participants
n=5 Participants
|
1747 Participants
n=7 Participants
|
1231 Participants
n=5 Participants
|
4725 Participants
n=4 Participants
|
|
HER2 status
HER2 negative
|
1787 Participants
n=5 Participants
|
1786 Participants
n=7 Participants
|
1247 Participants
n=5 Participants
|
4820 Participants
n=4 Participants
|
|
HER2 status
HER2 positive/equivocal
|
418 Participants
n=5 Participants
|
427 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
1133 Participants
n=4 Participants
|
|
Breast disease subtype
ER+ or PR+, HER2-
|
1437 Participants
n=5 Participants
|
1419 Participants
n=7 Participants
|
1015 Participants
n=5 Participants
|
3871 Participants
n=4 Participants
|
|
Breast disease subtype
ER+ or PR+, HER2+
|
292 Participants
n=5 Participants
|
312 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
809 Participants
n=4 Participants
|
|
Breast disease subtype
ER/PR-, HER2- (triple neg)
|
350 Participants
n=5 Participants
|
367 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
949 Participants
n=4 Participants
|
|
Breast disease subtype
ER/PR-, HER2+ (triple neg)
|
126 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
324 Participants
n=4 Participants
|
|
Stage
Stage I
|
721 Participants
n=5 Participants
|
770 Participants
n=7 Participants
|
509 Participants
n=5 Participants
|
2000 Participants
n=4 Participants
|
|
Stage
Stage II
|
992 Participants
n=5 Participants
|
954 Participants
n=7 Participants
|
694 Participants
n=5 Participants
|
2640 Participants
n=4 Participants
|
|
Stage
Stage III
|
472 Participants
n=5 Participants
|
460 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
1236 Participants
n=4 Participants
|
|
Chemotherapy
Not given or planned
|
446 Participants
n=5 Participants
|
454 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
1219 Participants
n=4 Participants
|
|
Chemotherapy
Given or planned
|
1779 Participants
n=5 Participants
|
1778 Participants
n=7 Participants
|
1232 Participants
n=5 Participants
|
4789 Participants
n=4 Participants
|
|
Hormonal Therapy
Not given or planned
|
542 Participants
n=5 Participants
|
535 Participants
n=7 Participants
|
367 Participants
n=5 Participants
|
1444 Participants
n=4 Participants
|
|
Hormonal Therapy
Given or planned
|
1670 Participants
n=5 Participants
|
1686 Participants
n=7 Participants
|
1170 Participants
n=5 Participants
|
4526 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrencePopulation: Only eligible patients will be included in the analysis.
Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.
Outcome measures
| Measure |
Arm I Zoledronate
n=2231 Participants
Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
zoledronic acid: Given IV
|
Arm II Clodronate
n=2235 Participants
Patients receive oral clodronate once daily for 35 months.
clodronate disodium: Given orally
|
Arm III Ibandronate
n=1552 Participants
Patients receive oral ibandronate once daily for 35 months.
ibandronate sodium: Given orally
|
|---|---|---|---|
|
Disease-free Survival
|
88 percentage of analyzed participants
Interval 87.0 to 90.0
|
88 percentage of analyzed participants
Interval 86.0 to 89.0
|
87 percentage of analyzed participants
Interval 86.0 to 89.0
|
SECONDARY outcome
Timeframe: follow up completed every 6 months for 5 years and then annually for 5 years or until deathPopulation: Only eligible patients will be included in the analysis.
Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The outcome for overall survival will be presented as 5 year overall survival rate.
Outcome measures
| Measure |
Arm I Zoledronate
n=2231 Participants
Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
zoledronic acid: Given IV
|
Arm II Clodronate
n=2235 Participants
Patients receive oral clodronate once daily for 35 months.
clodronate disodium: Given orally
|
Arm III Ibandronate
n=1552 Participants
Patients receive oral ibandronate once daily for 35 months.
ibandronate sodium: Given orally
|
|---|---|---|---|
|
Overall Survival
|
93 percentage of analyzable patients
Interval 91.0 to 94.0
|
92 percentage of analyzable patients
Interval 91.0 to 94.0
|
93 percentage of analyzable patients
Interval 92.0 to 94.0
|
SECONDARY outcome
Timeframe: Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrenceAll sites of invasive disease documented within 30 days of first documentation of invasive recurrence.
Outcome measures
| Measure |
Arm I Zoledronate
n=2231 Participants
Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
zoledronic acid: Given IV
|
Arm II Clodronate
n=2235 Participants
Patients receive oral clodronate once daily for 35 months.
clodronate disodium: Given orally
|
Arm III Ibandronate
n=1552 Participants
Patients receive oral ibandronate once daily for 35 months.
ibandronate sodium: Given orally
|
|---|---|---|---|
|
Distributions of Sites of First Recurrence on the Three Arms.
Local/Regional only
|
41 Participants
|
55 Participants
|
36 Participants
|
|
Distributions of Sites of First Recurrence on the Three Arms.
Contralateral only
|
17 Participants
|
18 Participants
|
17 Participants
|
|
Distributions of Sites of First Recurrence on the Three Arms.
Distant recurrence
|
218 Participants
|
207 Participants
|
146 Participants
|
|
Distributions of Sites of First Recurrence on the Three Arms.
Unknown location of recurrence
|
10 Participants
|
15 Participants
|
10 Participants
|
|
Distributions of Sites of First Recurrence on the Three Arms.
Bone as 1st site of distant recurrence
|
110 Participants
|
108 Participants
|
82 Participants
|
|
Distributions of Sites of First Recurrence on the Three Arms.
Bone only
|
62 Participants
|
48 Participants
|
44 Participants
|
|
Distributions of Sites of First Recurrence on the Three Arms.
Bone and nodes only
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Distributions of Sites of First Recurrence on the Three Arms.
Bone and other distant sites (beside nodes)
|
46 Participants
|
58 Participants
|
36 Participants
|
|
Distributions of Sites of First Recurrence on the Three Arms.
Liver/lung/other visceral without bone recurrence
|
57 Participants
|
67 Participants
|
40 Participants
|
|
Distributions of Sites of First Recurrence on the Three Arms.
Brain/other CNS (+/- any other site)
|
31 Participants
|
24 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.Population: Patients who received at least one dose of protocol treatment.
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Arm I Zoledronate
n=2113 Participants
Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
zoledronic acid: Given IV
|
Arm II Clodronate
n=2169 Participants
Patients receive oral clodronate once daily for 35 months.
clodronate disodium: Given orally
|
Arm III Ibandronate
n=1518 Participants
Patients receive oral ibandronate once daily for 35 months.
ibandronate sodium: Given orally
|
|---|---|---|---|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Allergic reaction/hypersensitivity
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Auditory/Ear-Other (Specify)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
CNS cerebrovascular ischemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Calcium, serum-low (hypocalcemia)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Confusion
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea (shortness of breath)
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Flu-like syndrome
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Left ventricular systolic dysfunction
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukocytes (total WBC)
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Memory impairment
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Metabolic/Laboratory-Other (Specify)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mood alteration - depression
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mood alteration - euphoria
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (clinical exam) - Oral cavity
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Muscle weakness, not d/t neuropathy - Extrem-upper
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Muscle weakness, not d/t neuropathy - body/general
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophils/granulocytes (ANC/AGC)
|
6 Participants
|
5 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Opportunistic inf associated w/gt=Gr 2 lymphopenia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Bone
|
47 Participants
|
19 Participants
|
19 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Chest wall
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Extremity-limb
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Head/headache
|
8 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Joint
|
39 Participants
|
35 Participants
|
42 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Oral cavity
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Pain NOS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Stomach
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Throat/pharynx/larynx
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Vagina
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pancreatitis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Secondary Malignancy-poss rel to cancer Tx
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syncope (fainting)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thrombosis/embolism (vascular access-related)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight gain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight loss
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
ALT, SGPT (serum glutamic pyruvic transaminase)
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
AST, SGOT
|
1 Participants
|
5 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alkaline phosphatase
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthritis (non-septic)
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bilirubin (hyperbilirubinemia)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blood/Bone Marrow-Other (Specify)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac General-Other (Specify)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Constipation
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Creatinine
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dental: periodontal disease
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dental: teeth
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
2 Participants
|
11 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Distention/bloating, abdominal
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dizziness
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dysphagia (difficulty swallowing)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Edema: limb
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Endocrine-Other (Specify)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Esophagitis
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Extremity-upper (function)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue (asthenia, lethargy, malaise)
|
11 Participants
|
10 Participants
|
7 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fracture
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastritis (including bile reflux gastritis)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Glucose, serum-high (hyperglycemia)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Heartburn/dyspepsia
|
2 Participants
|
22 Participants
|
22 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemoglobin
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage, GI - Rectum
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage, GI - Stomach
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hot flashes/flushes
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
INR (of prothrombin time)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Incontinence, urinary
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Bone
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Dental
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Appendix
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Liver
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Skin (cellulitis)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Insomnia
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Irregular menses (change from baseline)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Irritability (children lt3 years of age)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Joint-function
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphopenia
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Magnesium, serum-high (hypermagnesemia)
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Magnesium, serum-low (hypomagnesemia)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Masculinization of female
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mood alteration - anxiety
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Muscle weakness, not d/t neuropathy - Extrem-lower
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neuropathy: motor
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neuropathy: sensory
|
0 Participants
|
6 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Obesity
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Osteonecrosis (avascular necrosis)
|
6 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Abdomen NOS
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Back
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Chest/thorax NOS
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Muscle
|
23 Participants
|
5 Participants
|
16 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Neck
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Neuralgia/peripheral nerve
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain-Other (Specify)
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Perforation, GI - Duodenum
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Phosphate, serum-low (hypophosphatemia)
|
19 Participants
|
6 Participants
|
8 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Platelets
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Potassium, serum-high (hyperkalemia)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Potassium, serum-low (hypokalemia)
|
1 Participants
|
5 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Proteinuria
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pruritus/itching
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash/desquamation
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Renal failure
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Renal/Genitourinary-Other (Specify)
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Retinal detachment
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rigors/chills
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sexual/Reproductive Function-Other (Specify)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sodium, serum-low (hyponatremia)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Soft tissue necrosis - Head
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thrombosis/thrombus/embolism
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Tinnitus
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urticaria (hives, welts, wheals)
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Arm I Zoledronic Acid
Serious events: 21 serious events
Other events: 1854 other events
Deaths: 238 deaths
Arm II Clodronate
Serious events: 190 serious events
Other events: 1942 other events
Deaths: 263 deaths
Arm III Ibandronate
Serious events: 141 serious events
Other events: 1366 other events
Deaths: 182 deaths
Serious adverse events
| Measure |
Arm I Zoledronic Acid
n=2125 participants at risk
Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
zoledronic acid: Given IV
|
Arm II Clodronate
n=2186 participants at risk
Patients receive oral clodronate once daily for 35 months.
clodronate disodium: Given orally
|
Arm III Ibandronate
n=1530 participants at risk
Patients receive oral ibandronate once daily for 35 months.
ibandronate sodium: Given orally
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.39%
6/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
Cardiac General-Other
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
0.05%
1/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.26%
4/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
Conduction abnorm/AV block - Sick sinus syndrome
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.26%
4/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
Pain - Cardiac/heart
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial fibrillation
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.18%
4/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial tachycardia/PAT
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
SVT and nodal arrhythmia - SVT tachycardia
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus bradycardia
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus tachycardia
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
Valvular heart disease
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
Ventricular arrhythmia - PVCs
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Cardiac disorders
Ventricular arrhythmia - Ventricular fibrillation
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Endocrine disorders
Endocrine-Other
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Eye disorders
Ocular/Visual-Other
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Dental: periodontal disease
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.18%
4/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Fistula, GI - Colon/cecum/appendix
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Cecum/appendix
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Esophagus
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Stomach
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Varices (rectal)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.33%
5/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Obstruction, GI - Cecum
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Obstruction, GI - Small bowel NOS
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.23%
5/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Obstruction, GI - Stomach
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.46%
10/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Perforation, GI - Duodenum
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Ulcer, GI - Stomach
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.20%
3/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Edema: head and neck
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Edema: limb
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.18%
4/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Pain - Chest/thorax NOS
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.20%
3/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Pain - Pain NOS
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Pain-Other
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Sudden death
|
0.05%
1/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Syndromes-Other
|
0.05%
1/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.18%
4/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.46%
7/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Hepatobiliary disorders
Pain - Liver
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.18%
4/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
0.05%
1/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Colon
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Kidney
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.18%
4/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.20%
3/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lymphatic
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.73%
16/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.78%
12/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Wound
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils-Foreign bod
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutroph
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with unknown ANC - Appendix
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with unknown ANC - Blood
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with unknown ANC - Bronchus
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with unknown ANC - Catheter-related
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with unknown ANC - Duodenum
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with unknown ANC - Foreign body (e.g., g
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with unknown ANC - Heart (endocarditis)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.20%
3/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with unknown ANC - Skin (cellulitis)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.46%
10/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.20%
3/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with unknown ANC - Soft tissue NOS
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with unknown ANC - Upper airway NOS
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection with unknown ANC - Wound
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.32%
7/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Infections and infestations
Infection-Other
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.20%
3/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.50%
11/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.65%
10/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Injury, poisoning and procedural complications
Intra-operative Injury-Other
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Injury, poisoning and procedural complications
Intra-operative injury - Ovary
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Injury, poisoning and procedural complications
Leak (including anastomotic), GI - Leak NOS
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated w/radiation
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access-related)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Injury, poisoning and procedural complications
Vessel injury-artery - Carotid
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.23%
5/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
AST, SGOT
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.18%
4/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Creatinine
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Leukocytes (total WBC)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Lymphopenia
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.23%
5/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.20%
3/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.37%
8/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.26%
4/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Pancreatic endocrine: glucose intolerance
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue-Other
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis)
|
0.61%
13/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.23%
5/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.33%
5/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.20%
3/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
0.05%
1/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - Tumor pain
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy-poss rel to cancer Tx
|
0.09%
2/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Ataxia (incoordination)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.18%
4/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.26%
4/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.23%
5/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Hemorrhage, CNS
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Neurology-Other
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Neuropathy: CN VII Motor-face; Sensory-taste
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Neuropathy: sensory
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Ocular/Visual-Other
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Pain - Head/headache
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.32%
7/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.33%
5/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Vasovagal episode
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Psychiatric disorders
Mood alteration - depression
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Psychiatric disorders
Personality/behavioral
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Renal and urinary disorders
Glomerular filtration rate
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Renal and urinary disorders
Hemorrhage, GU - Ureter
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Renal and urinary disorders
Obstruction, GU - Ureter
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Renal and urinary disorders
Pain - Bladder
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Renal and urinary disorders
Pain - Kidney
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Renal and urinary disorders
Renal/Genitourinary-Other
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Reproductive system and breast disorders
Hemorrhage, GU - Uterus
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function-Other
|
0.05%
1/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.26%
4/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.46%
10/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.59%
9/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Larynx
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.20%
3/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.13%
2/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.14%
3/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Vascular disorders
Hematoma
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.05%
1/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.09%
2/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.00%
0/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.07%
1/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.41%
9/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
0.65%
10/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
Other adverse events
| Measure |
Arm I Zoledronic Acid
n=2125 participants at risk
Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
zoledronic acid: Given IV
|
Arm II Clodronate
n=2186 participants at risk
Patients receive oral clodronate once daily for 35 months.
clodronate disodium: Given orally
|
Arm III Ibandronate
n=1530 participants at risk
Patients receive oral ibandronate once daily for 35 months.
ibandronate sodium: Given orally
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
13.9%
295/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
11.6%
253/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
13.9%
213/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
17.7%
376/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
14.9%
326/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
16.4%
251/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Constipation
|
10.8%
230/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
11.8%
259/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
11.8%
180/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
288/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
20.4%
447/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
14.6%
223/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
6.5%
138/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
15.2%
332/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
18.3%
280/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Nausea
|
21.4%
454/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
25.4%
555/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
20.1%
307/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
6.3%
133/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
6.7%
146/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
6.5%
100/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
158/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
11.1%
243/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
8.0%
123/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Edema: limb
|
11.4%
243/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
9.7%
212/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
10.7%
163/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
40.0%
851/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
34.3%
749/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
36.6%
560/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
12.3%
261/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
3.8%
82/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
4.6%
70/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Flu-like syndrome
|
5.1%
108/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
1.1%
24/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
1.2%
18/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Pain-Other
|
8.7%
185/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
6.8%
149/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
8.0%
122/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
General disorders
Rigors/chills
|
5.1%
109/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
1.2%
27/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
1.2%
18/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated w/radiation
|
5.1%
108/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
4.6%
100/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
4.6%
70/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
13.6%
290/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
24.7%
540/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
11.1%
170/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
AST, SGOT
|
14.5%
308/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
26.6%
581/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
12.4%
190/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Alkaline phosphatase
|
5.4%
114/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
7.6%
166/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
5.0%
77/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Creatinine
|
9.6%
205/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
10.5%
230/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
8.3%
127/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Leukocytes (total WBC)
|
17.2%
366/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
16.9%
370/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
13.4%
205/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Lymphopenia
|
9.8%
209/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
8.3%
181/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
8.2%
125/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Metabolic/Laboratory-Other
|
5.6%
120/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
6.0%
132/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
4.4%
67/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
7.5%
160/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
9.7%
213/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
6.5%
100/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Platelets
|
5.6%
118/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
6.4%
140/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
3.3%
51/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Investigations
Weight gain
|
5.8%
124/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
6.3%
137/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
5.3%
81/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
5.1%
109/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
4.4%
97/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
4.0%
61/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
9.2%
196/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
7.4%
162/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
7.3%
111/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
22.8%
484/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
19.6%
429/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
18.5%
283/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
5.6%
119/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
3.8%
84/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
3.8%
58/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
5.6%
120/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
4.0%
88/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
5.4%
82/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
7.0%
148/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
4.0%
87/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
5.2%
80/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
8.1%
172/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
8.6%
189/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
5.8%
88/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
5.4%
114/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
4.8%
106/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
5.1%
78/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
9.7%
206/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
9.0%
197/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
9.3%
143/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
28.9%
614/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
17.8%
390/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
19.8%
303/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
12.2%
260/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
10.6%
231/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
11.3%
173/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
50.4%
1071/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
44.3%
968/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
49.4%
756/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
23.0%
488/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
15.5%
339/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
19.2%
294/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Dizziness
|
9.2%
196/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
7.2%
157/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
8.8%
134/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Neuropathy: sensory
|
21.8%
464/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
20.4%
447/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
20.3%
311/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Nervous system disorders
Pain - Head/headache
|
14.6%
310/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
12.4%
270/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
13.4%
205/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Psychiatric disorders
Insomnia
|
16.2%
345/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
14.2%
310/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
13.3%
204/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Psychiatric disorders
Mood alteration - anxiety
|
8.4%
178/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
7.3%
159/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
6.9%
106/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Psychiatric disorders
Mood alteration - depression
|
11.1%
236/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
10.4%
227/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
9.9%
151/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Reproductive system and breast disorders
Pain - Breast
|
6.1%
129/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
6.6%
144/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
6.7%
102/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
6.0%
128/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
6.3%
137/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
5.9%
90/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.2%
216/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
9.9%
216/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
9.3%
143/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
8.7%
185/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
6.1%
133/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
7.6%
116/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
6.5%
138/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
5.5%
120/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
5.9%
90/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
14.4%
306/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
14.0%
307/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
12.7%
194/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
4.6%
97/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
4.4%
97/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
5.2%
79/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Vascular disorders
Hot flashes/flushes
|
37.4%
795/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
37.0%
808/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
37.8%
579/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
|
Vascular disorders
Hypertension
|
4.4%
94/2125 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
5.8%
127/2186 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
3.9%
60/1530 • Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
|
Additional Information
SWOG statistician
SWOG Statistics & Data Management Center
Phone: 2066674263
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60