Trial Outcomes & Findings for S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells for Metastatic Breast Cancer Treated With Chemo (NCT NCT00382018)
NCT ID: NCT00382018
Last Updated: 2017-11-06
Results Overview
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
624 participants
Primary outcome timeframe
Every 3 months until progression then every 6 months for 5 years or until death
Results posted on
2017-11-06
Participant Flow
624 patients were registered for screening. 29 patients were excluded due to initial CTC test not completed(17) and ineligible(12). 276 did not have increased CTC levels (Arm A). 319 patients had increased CTC levels. Additional 31 patients were excluded from 319 due to no CTC values on Day 21. Thus total 288 patients in ArmB, ArmC2 and ArmC2.
Participant milestones
| Measure |
Arm A (Baseline CTCs < 5, Low Risk)
Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
|
Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but \< 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
|
Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
|
Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and \>= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
276
|
165
|
64
|
59
|
|
Overall Study
COMPLETED
|
276
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
165
|
64
|
59
|
Reasons for withdrawal
| Measure |
Arm A (Baseline CTCs < 5, Low Risk)
Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
|
Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but \< 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
|
Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
|
Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and \>= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
|
|---|---|---|---|---|
|
Overall Study
Progression
|
0
|
136
|
51
|
43
|
|
Overall Study
Death
|
0
|
9
|
7
|
11
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
3
|
4
|
|
Overall Study
Other, not protocol specified
|
0
|
16
|
3
|
1
|
Baseline Characteristics
Only patients classified by disease subtype category will be included in the analysis.
Baseline characteristics by cohort
| Measure |
Arm A (Baseline CTCs < 5, Low Risk)
n=276 Participants
Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
|
Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)
n=165 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but \< 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
|
Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=64 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
|
Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=59 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and \>= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
|
Total
n=564 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age 55 years or older
|
163 Participants
n=276 Participants
|
94 Participants
n=165 Participants
|
38 Participants
n=64 Participants
|
39 Participants
n=59 Participants
|
334 Participants
n=564 Participants
|
|
Sex: Female, Male
Female
|
276 Participants
n=276 Participants
|
165 Participants
n=165 Participants
|
64 Participants
n=64 Participants
|
59 Participants
n=59 Participants
|
564 Participants
n=564 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=276 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=564 Participants
|
|
Black Race
|
50 Participants
n=276 Participants
|
23 Participants
n=165 Participants
|
15 Participants
n=64 Participants
|
7 Participants
n=59 Participants
|
95 Participants
n=564 Participants
|
|
Measurable disease
|
221 Participants
n=276 Participants
|
137 Participants
n=165 Participants
|
47 Participants
n=64 Participants
|
50 Participants
n=59 Participants
|
455 Participants
n=564 Participants
|
|
No. of patients classified by disease subtype
|
275 Participants
n=276 Participants
|
162 Participants
n=165 Participants
|
64 Participants
n=64 Participants
|
59 Participants
n=59 Participants
|
560 Participants
n=564 Participants
|
|
Homo receptor positive, HER2 negative
|
148 Participants
n=275 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
93 Participants
n=162 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
50 Participants
n=64 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
39 Participants
n=59 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
330 Participants
n=560 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
|
Triple negative
|
74 Participants
n=275 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
33 Participants
n=162 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
11 Participants
n=64 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
16 Participants
n=59 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
134 Participants
n=560 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
|
HER2 positive
|
53 Participants
n=275 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
36 Participants
n=162 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
3 Participants
n=64 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
4 Participants
n=59 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
96 Participants
n=560 Participants • Only patients classified by disease subtype category will be included in the analysis.
|
PRIMARY outcome
Timeframe: Every 3 months until progression then every 6 months for 5 years or until deathFrom date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=64 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
|
Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=59 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and \>= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
|
Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
|
|---|---|---|---|
|
Overall Survival
|
10.7 months
Interval 9.1 to 14.8
|
12.5 months
Interval 8.4 to 16.3
|
—
|
PRIMARY outcome
Timeframe: every 3 months until progression. From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first, assessed up to five years.Population: Three patients in Arm C2 were judged as progression on day 22 and were excluded from the PFS analysis but were included in the OS analysis.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=64 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
|
Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=56 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and \>= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
|
Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
|
|---|---|---|---|
|
Progression-free Survival
|
3.5 months
Interval 2.1 to 4.7
|
4.6 months
Interval 3.1 to 6.7
|
—
|
PRIMARY outcome
Timeframe: Every 3 months until progression then every 6 months for 5 years or until deathFrom date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=276 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
|
Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=165 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and \>= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
|
Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=123 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
|
|---|---|---|---|
|
Overall Survival
|
35 months
Interval 29.0 to 38.5
|
23 months
Interval 19.0 to 28.3
|
13 months
Interval 10.2 to 15.0
|
PRIMARY outcome
Timeframe: every 3 months until progressionPopulation: Three patients in Arm C were judged as progressing on day 22 and were excluded from the PFS analysis but were included in the OS analysis.
From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first. Patients last known to be alive and progression-free are censored at date of last contact.
Outcome measures
| Measure |
Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=276 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
|
Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=165 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and \>= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
|
Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=120 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
|
|---|---|---|---|
|
Progression Free Survival
|
11.1 months
Interval 9.5 to 12.5
|
8.9 months
Interval 8.1 to 10.8
|
4.9 months
Interval 3.8 to 5.7
|
SECONDARY outcome
Timeframe: Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progressionPopulation: Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. And only patients who were evaluable for Adverse Event Assessment were included in the following analysis results.
Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=161 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
|
Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=64 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and \>= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
|
Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=56 Participants
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
|
|---|---|---|---|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Insomnia
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
ALT, SGPT (serum glutamic pyruvic transaminase)
|
8 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
AST, SGOT
|
10 Participants
|
1 Participants
|
6 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Albumin, serum-low (hypoalbuminemia)
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Alkaline phosphatase
|
7 Participants
|
5 Participants
|
8 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Allergic reaction/hypersensitivity
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Allergic rhinitis
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Allergy/Immunology-Other (Specify)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Anorexia
|
16 Participants
|
5 Participants
|
9 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Ascites (non-malignant)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Auditory/Ear-Other (Specify)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Bilirubin (hyperbilirubinemia)
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Blood/Bone Marrow-Other (Specify)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
CNS cerebrovascular ischemia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Calcium, serum-high (hypercalcemia)
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Calcium, serum-low (hypocalcemia)
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Confusion
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Constipation
|
12 Participants
|
5 Participants
|
6 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Constitutional Symptoms-Other (Specify)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Cough
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Creatinine
|
15 Participants
|
5 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Dehydration
|
17 Participants
|
6 Participants
|
7 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Dermatology/Skin-Other (Specify)
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Diarrhea
|
55 Participants
|
10 Participants
|
15 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Distention/bloating, abdominal
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Dizziness
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Dry eye syndrome
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Dry mouth/salivary gland (xerostomia)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Dry skin
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Dyspnea (shortness of breath)
|
18 Participants
|
9 Participants
|
9 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Edema: head and neck
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Edema: limb
|
3 Participants
|
0 Participants
|
6 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Fatigue (asthenia, lethargy, malaise)
|
103 Participants
|
36 Participants
|
36 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
6 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Flatulence
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Flushing
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Gastrointestinal-Other (Specify)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Glucose, serum-high (hyperglycemia)
|
13 Participants
|
4 Participants
|
7 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Glucose, serum-low (hypoglycemia)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Hair loss/Alopecia (scalp or body)
|
20 Participants
|
5 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Heartburn/dyspepsia
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Hemoglobin
|
100 Participants
|
32 Participants
|
38 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Hemorrhage, Respiratory tract NOS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Hemorrhage, GI - Stomach
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Hemorrhage, GU - Uterus
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Hemorrhage, pulmonary/upper respiratory - Nose
|
7 Participants
|
4 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Hot flashes/flushes
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Hyperpigmentation
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Hypertension
|
6 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Hypotension
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Ileus, GI (functional obstruction of bowel)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Induration/fibrosis (skin and subcutaneous tissue)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - UTI
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Nose
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Sinus
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Skin (cellulitis)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Urinary tract NOS
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Infection-Other (Specify)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Injection site reaction/extravasation changes
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Left ventricular systolic dysfunction
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Leukocytes (total WBC)
|
28 Participants
|
11 Participants
|
10 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Lymphopenia
|
8 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Magnesium, serum-low (hypomagnesemia)
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Memory impairment
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Metabolic/Laboratory-Other (Specify)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Mood alteration - anxiety
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Mood alteration - depression
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (clinical exam) - Oral cavity
|
10 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (functional/symp) - Oral cav
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Muscle weakness, not d/t neuropathy - Extrem-lower
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Muscle weakness, not d/t neuropathy - Extrem-upper
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Muscle weakness, not d/t neuropathy - body/general
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Musculoskeletal/Soft Tissue-Other (Specify)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Nail changes
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Nasal cavity/paranasal sinus reactions
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Nausea
|
27 Participants
|
10 Participants
|
10 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Neuropathy: motor
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Neuropathy: sensory
|
23 Participants
|
3 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Neutrophils/granulocytes (ANC/AGC)
|
71 Participants
|
23 Participants
|
25 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Ocular/Visual-Other (Specify)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Osteonecrosis (avascular necrosis)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Abdomen NOS
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Back
|
6 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Bladder
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Bone
|
27 Participants
|
8 Participants
|
9 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Breast
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Chest wall
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Chest/thorax NOS
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Extremity-limb
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Face
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Head/headache
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Joint
|
8 Participants
|
1 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Muscle
|
10 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Neck
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Neuralgia/peripheral nerve
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Oral cavity
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Oral-gums
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Pain NOS
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Pelvis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Rectum
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Scalp
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Stomach
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Throat/pharynx/larynx
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain - Vagina
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pain-Other (Specify)
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Phosphate, serum-low (hypophosphatemia)
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Platelets
|
42 Participants
|
16 Participants
|
23 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pleural effusion (non-malignant)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pneumonitis/pulmonary infiltrates
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Potassium, serum-high (hyperkalemia)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Potassium, serum-low (hypokalemia)
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Proteinuria
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pruritus/itching
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Pulmonary/Upper Respiratory-Other (Specify)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Rash/desquamation
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Rash: acne/acneiform
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Rash: hand-foot skin reaction
|
10 Participants
|
4 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Renal/Genitourinary-Other (Specify)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Restrictive cardiomyopathy
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Retinopathy
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Rigors/chills
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
SVT and nodal arrhythmia - Atrial tachycardia/PAT
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
SVT and nodal arrhythmia - Sinus tachycardia
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Sodium, serum-high (hypernatremia)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Sodium, serum-low (hyponatremia)
|
6 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Sweating (diaphoresis)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Syndromes-Other (Specify)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Taste alteration (dysgeusia)
|
6 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Thrombosis/thrombus/embolism
|
5 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Thyroid function, high
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Triglyceride, serum-high (hypertriglyceridemia)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Urinary frequency/urgency
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Vaginal dryness
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Vision-blurred vision
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Vomiting
|
38 Participants
|
10 Participants
|
14 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Watery eye (epiphora, tearing)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Related to Study Drugs
Weight loss
|
8 Participants
|
2 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Weeks 4, 8, 13, 25, 37 and at progressionOutcome measures
Outcome data not reported
Adverse Events
Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)
Serious events: 0 serious events
Other events: 152 other events
Deaths: 0 deaths
Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Serious events: 1 serious events
Other events: 57 other events
Deaths: 0 deaths
Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)
n=161 participants at risk
|
Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=64 participants at risk
|
Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=56 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
0.00%
0/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
1.6%
1/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
0.00%
0/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
1.6%
1/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
0.00%
0/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Renal and urinary disorders
Renal/Genitourinary-Other
|
0.00%
0/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
1.6%
1/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
0.00%
0/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
Other adverse events
| Measure |
Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)
n=161 participants at risk
|
Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=64 participants at risk
|
Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
n=56 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
69.6%
112/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
54.7%
35/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
76.8%
43/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Gastrointestinal disorders
Constipation
|
12.4%
20/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
12.5%
8/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
14.3%
8/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Gastrointestinal disorders
Diarrhea
|
41.0%
66/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
23.4%
15/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
28.6%
16/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
6.8%
11/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
0.00%
0/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
3.6%
2/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Gastrointestinal disorders
Nausea
|
18.6%
30/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
15.6%
10/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
19.6%
11/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
2.5%
4/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
7.8%
5/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
3.6%
2/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Gastrointestinal disorders
Vomiting
|
32.3%
52/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
26.6%
17/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
30.4%
17/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
General disorders
Edema: limb
|
9.3%
15/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
3.1%
2/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
14.3%
8/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
69.6%
112/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
62.5%
40/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
75.0%
42/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
4.3%
7/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
6.2%
4/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
3.6%
2/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
General disorders
Pain - Pain NOS
|
1.9%
3/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
1.6%
1/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
General disorders
Pain-Other
|
3.1%
5/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
6.2%
4/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
7.1%
4/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
1.2%
2/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
1.6%
1/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
8.1%
13/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
7.8%
5/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Investigations
AST, SGOT
|
10.6%
17/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
7.8%
5/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
17.9%
10/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Investigations
Alkaline phosphatase
|
8.7%
14/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
10.9%
7/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
17.9%
10/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
6.8%
11/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
4.7%
3/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
12.5%
7/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Investigations
Creatinine
|
14.9%
24/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
12.5%
8/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
12.5%
7/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Investigations
Leukocytes (total WBC)
|
18.0%
29/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
17.2%
11/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
17.9%
10/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Investigations
Lymphopenia
|
5.6%
9/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
3.1%
2/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Investigations
Metabolic/Laboratory-Other
|
1.9%
3/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
1.6%
1/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
47.8%
77/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
37.5%
24/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
50.0%
28/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Investigations
Platelets
|
30.4%
49/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
29.7%
19/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
44.6%
25/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Investigations
Weight loss
|
6.2%
10/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
6.2%
4/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
5.0%
8/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
4.7%
3/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
10.7%
6/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.8%
19/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
7.8%
5/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
19.6%
11/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
2.5%
4/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
1.6%
1/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
5.6%
9/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
6.2%
4/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
12.5%
7/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.8%
27/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
12.5%
8/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
17.9%
10/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
13.7%
22/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
10.9%
7/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
12.5%
7/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
3.7%
6/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
6.2%
4/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
7.1%
4/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
5.0%
8/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
1.6%
1/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
7.1%
4/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
1.2%
2/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
1.6%
1/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
10.7%
6/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
12.4%
20/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
6.2%
4/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
10.7%
6/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
39.8%
64/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
32.8%
21/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
35.7%
20/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
4.3%
7/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
1.6%
1/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
11.2%
18/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
6.2%
4/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
12.5%
7/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
8.7%
14/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
4.7%
3/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Nervous system disorders
Dizziness
|
3.7%
6/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
3.1%
2/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Nervous system disorders
Neuropathy: sensory
|
17.4%
28/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
6.2%
4/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
12.5%
7/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Nervous system disorders
Pain - Head/headache
|
5.0%
8/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
7.8%
5/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
8.9%
5/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Psychiatric disorders
Mood alteration - anxiety
|
2.5%
4/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
3.1%
2/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
14/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
7.8%
5/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
7.1%
4/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
32.9%
53/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
28.1%
18/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
35.7%
20/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
4.3%
7/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
6.2%
4/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
0.00%
0/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
0.00%
0/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
12.4%
20/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
7.8%
5/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
10.7%
6/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
1.2%
2/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
1.6%
1/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
7.1%
4/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.5%
4/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
0.00%
0/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
6.2%
10/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
6.2%
4/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
5.4%
3/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
|
Vascular disorders
Hot flashes/flushes
|
2.5%
4/161 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
1.6%
1/64 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
7.1%
4/56 • Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60