Trial Outcomes & Findings for A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer (NCT NCT00636610)
NCT ID: NCT00636610
Last Updated: 2017-06-08
Results Overview
Progression-free survival (PFS) was defined as the time from randomization to the earlier of documented disease progression (PD) or death from any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. For patients without measurable disease, PD was defined as an increase in the size of a lesion to one that is measurable or unequivocal progression of a non-target lesion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
199 participants
Primary outcome timeframe
From first treatment through the data cut-off date of March 15, 2010, up to 90 weeks
Results posted on
2017-06-08
Participant Flow
Participant milestones
| Measure |
Vismodegib 150 mg
Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
|
Placebo to Vismodegib
Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
101
|
|
Overall Study
COMPLETED
|
6
|
18
|
|
Overall Study
NOT COMPLETED
|
92
|
83
|
Reasons for withdrawal
| Measure |
Vismodegib 150 mg
Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
|
Placebo to Vismodegib
Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Death
|
6
|
3
|
|
Overall Study
Physician decision to withdraw patient
|
15
|
9
|
|
Overall Study
Subject decision to withdraw
|
15
|
11
|
|
Overall Study
Disease progression - radiographic
|
41
|
51
|
|
Overall Study
Disease progression - clinical
|
8
|
3
|
|
Overall Study
Reason for discontinuation not available
|
3
|
2
|
Baseline Characteristics
A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Vismodegib 150 mg
n=98 Participants
Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
|
Placebo to Vismodegib
n=101 Participants
Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first treatment through the data cut-off date of March 15, 2010, up to 90 weeksPopulation: Intent-to-treat patient population: All randomized patients.
Progression-free survival (PFS) was defined as the time from randomization to the earlier of documented disease progression (PD) or death from any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. For patients without measurable disease, PD was defined as an increase in the size of a lesion to one that is measurable or unequivocal progression of a non-target lesion.
Outcome measures
| Measure |
Vismodegib 150 mg
n=98 Participants
Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
|
Placebo to Vismodegib
n=101 Participants
Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
9.3 Months
Interval 7.98 to 10.51
|
10.1 Months
Interval 9.43 to 11.33
|
SECONDARY outcome
Timeframe: From first treatment through the data cut-off date of March 15, 2010, up to 90 weeksPopulation: Intent-to-treat patient population: All randomized patients. Tissue for evaluation was only available for 64 patients in the vismodegib group and 75 patients in the placebo group.
Indian + Sonic Hedgehog antigen expression was measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from archival tumor tissue taken from each patient prior to enrollment in the study. Results are reported in 3 categories; the 33% of patients with the lowest level of expression, the 35% of patients with a middle level of expression, and the 32% of patients with the highest level of expression. PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason.
Outcome measures
| Measure |
Vismodegib 150 mg
n=64 Participants
Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
|
Placebo to Vismodegib
n=75 Participants
Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
|
|---|---|---|
|
Progression-free Survival (PFS) in Patients With Various Degrees of Hedgehog Antigen Tumor Expression
≤ 33%, n=(16,30)
|
9.2 Months
Interval 3.6 to 15.9
|
9.4 Months
Interval 7.0 to 11.3
|
|
Progression-free Survival (PFS) in Patients With Various Degrees of Hedgehog Antigen Tumor Expression
33% - 67%, n=(18,28)
|
7.4 Months
Interval 5.8 to 8.2
|
11.3 Months
Interval 7.1 to 15.8
|
|
Progression-free Survival (PFS) in Patients With Various Degrees of Hedgehog Antigen Tumor Expression
> 67%, n=(30,17)
|
10.7 Months
Interval 7.9 to 11.5
|
14.4 Months
Interval 5.3 to
The upper limit of the confidence interval could not be estimated due to sparse data above the median.
|
Adverse Events
Placebo With FOLFOX+Bevacizumab
Serious events: 21 serious events
Other events: 62 other events
Deaths: 0 deaths
Vismodegib (GDC-0449) With FOLFOX+Bevacizumab
Serious events: 29 serious events
Other events: 61 other events
Deaths: 0 deaths
Placebo With FOLFIRI+Bevacizumab
Serious events: 9 serious events
Other events: 36 other events
Deaths: 0 deaths
Vismodegib (GDC-0449) With FOLFIRI+Bevacizumab
Serious events: 18 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo With FOLFOX+Bevacizumab
n=62 participants at risk
Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
|
Vismodegib (GDC-0449) With FOLFOX+Bevacizumab
n=61 participants at risk
GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
|
Placebo With FOLFIRI+Bevacizumab
n=36 participants at risk
Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
|
Vismodegib (GDC-0449) With FOLFIRI+Bevacizumab
n=37 participants at risk
GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Small Intestinal Perforation
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
4.9%
3/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
3.2%
2/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Colonic Obstruction
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Erosive Oesophagitis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Oesophageal Ulcer
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Anal Fissure
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
4.9%
3/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Asthenia
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Chest Pain
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Pain
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Pyrexia
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Sudden Death
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Breast Infection
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Abdominal Abscess
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Appendicitis Perforated
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Catheter Site Infection
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Gastroenteritis Viral
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Perirectal Abscess
|
3.2%
2/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
3.2%
2/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Investigations
Weight Decreased
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
2/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.5%
7/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Nervous system disorders
Reversible Posterior Leukoencephalopathy Syndrome
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
4.9%
3/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Renal and urinary disorders
Ureteric Obstruction
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.2%
5/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.3%
3/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
6.6%
4/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Vascular disorders
Vena Cava Thrombosis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Vascular disorders
Malignant Hypertension
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
Other adverse events
| Measure |
Placebo With FOLFOX+Bevacizumab
n=62 participants at risk
Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
|
Vismodegib (GDC-0449) With FOLFOX+Bevacizumab
n=61 participants at risk
GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
|
Placebo With FOLFIRI+Bevacizumab
n=36 participants at risk
Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
|
Vismodegib (GDC-0449) With FOLFIRI+Bevacizumab
n=37 participants at risk
GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
|
|---|---|---|---|---|
|
Nervous system disorders
Neuropathy Peripheral
|
54.8%
34/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
31.1%
19/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.7%
6/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
41.9%
26/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
31.1%
19/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
36.1%
13/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
37.8%
14/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.9%
21/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
23.0%
14/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
30.6%
11/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.2%
6/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
30.6%
19/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
14.8%
9/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.9%
5/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
17.7%
11/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
9.8%
6/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.7%
6/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
10.8%
4/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.5%
4/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Eye disorders
Lacrimation Increased
|
3.2%
2/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
4.9%
3/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.2%
6/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Nausea
|
64.5%
40/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
62.3%
38/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
58.3%
21/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
62.2%
23/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
58.1%
36/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
49.2%
30/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
80.6%
29/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
59.5%
22/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Vomiting
|
25.8%
16/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
37.7%
23/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
41.7%
15/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
51.4%
19/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Constipation
|
33.9%
21/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
32.8%
20/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
36.1%
13/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
32.4%
12/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
21.0%
13/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
19.7%
12/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
22.2%
8/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.2%
6/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
19.4%
12/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.1%
8/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.3%
3/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
18.9%
7/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.5%
9/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
9.8%
6/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.9%
5/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
21.6%
8/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.2%
2/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.2%
5/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.3%
3/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.1%
3/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
6.6%
4/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.1%
4/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.1%
3/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Oral Pain
|
6.5%
4/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
10.8%
4/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
22.6%
14/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
32.8%
20/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.1%
4/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
6.5%
4/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
6.6%
4/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.3%
3/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
22.2%
8/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.1%
3/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
8.1%
5/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Flatulence
|
6.5%
4/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.1%
4/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Fatigue
|
67.7%
42/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
65.6%
40/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
80.6%
29/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
73.0%
27/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Mucosal Inflammation
|
25.8%
16/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
24.6%
15/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
22.2%
8/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
35.1%
13/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Asthenia
|
9.7%
6/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.4%
10/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.3%
3/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
24.3%
9/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Temperature Intolerance
|
32.3%
20/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
19.7%
12/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Pyrexia
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.5%
7/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.7%
6/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.5%
5/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Chest Pain
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.2%
5/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.6%
2/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
10.8%
4/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Oedema Peripheral
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
9.8%
6/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
19.4%
7/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Pain
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.2%
5/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.3%
3/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
General disorders
Chills
|
6.5%
4/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
4.9%
3/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Immune system disorders
Seasonal Allergy
|
3.2%
2/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.1%
4/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
8.1%
5/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
18.0%
11/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
22.2%
8/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.5%
5/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Sinusitis
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.2%
5/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.3%
3/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
10.8%
4/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.1%
3/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
4.9%
3/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.3%
3/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.7%
6/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
4.9%
3/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.1%
4/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
6.6%
4/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.3%
3/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
2/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.1%
3/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Investigations
Weight Decreased
|
14.5%
9/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
32.8%
20/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.1%
4/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
40.5%
15/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
8.1%
5/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
4.9%
3/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.6%
2/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.1%
3/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
8.1%
5/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.6%
2/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
9.7%
6/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.6%
2/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
22.6%
14/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
50.8%
31/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
27.8%
10/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
48.6%
18/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.7%
6/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
21.3%
13/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.3%
3/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
29.7%
11/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.7%
6/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.4%
10/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.1%
4/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.1%
3/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.1%
5/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.1%
8/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.3%
3/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.9%
8/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.2%
5/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.6%
2/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.5%
7/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
24.3%
9/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.4%
12/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.5%
7/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.1%
4/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.5%
5/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
9.7%
6/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.5%
7/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
19.4%
7/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
10.8%
4/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.7%
6/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
6.6%
4/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.7%
6/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.5%
5/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.2%
5/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.1%
4/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.3%
3/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
10.8%
4/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
6.5%
4/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.6%
2/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.6%
2/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Nervous system disorders
Dysgeusia
|
12.9%
8/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
47.5%
29/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
32.4%
12/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Nervous system disorders
Dizziness
|
16.1%
10/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
23.0%
14/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.6%
2/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.1%
3/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Nervous system disorders
Headache
|
25.8%
16/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
14.8%
9/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.9%
5/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.5%
5/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Nervous system disorders
Syncope
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
6.6%
4/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
3.2%
2/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
6.6%
4/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Psychiatric disorders
Insomnia
|
17.7%
11/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.5%
7/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
25.0%
9/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.5%
5/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Psychiatric disorders
Anxiety
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
6.6%
4/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.7%
6/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
18.9%
7/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Psychiatric disorders
Depression
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
9.8%
6/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.9%
5/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
10.8%
4/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Renal and urinary disorders
Proteinuria
|
14.5%
9/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
9.8%
6/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.7%
6/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.5%
5/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.8%
16/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
26.2%
16/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
47.2%
17/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.2%
6/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.7%
6/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
21.3%
13/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.1%
4/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.2%
6/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.3%
7/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
14.8%
9/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
25.0%
9/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.2%
6/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.2%
5/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.1%
4/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.2%
5/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
4.9%
3/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.3%
3/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.9%
5/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.1%
3/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.1%
5/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
1.6%
1/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.1%
4/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.5%
9/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
18.0%
11/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
25.0%
9/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
21.6%
8/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.9%
8/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
9.8%
6/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.7%
6/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.7%
1/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
6.5%
4/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
9.8%
6/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
16.7%
6/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
0.00%
0/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.8%
3/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.9%
5/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
8.1%
3/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.6%
1/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
4.9%
3/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
2.8%
1/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.5%
4/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
3.3%
2/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
11.1%
4/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Vascular disorders
Hypertension
|
17.7%
11/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
9.8%
6/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.9%
5/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.5%
5/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/62 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
9.8%
6/61 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
13.9%
5/36 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
5.4%
2/37 • Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
|
Additional Information
Medical Communications
Genentech, Inc.
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER