Trial Outcomes & Findings for S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer (NCT NCT02438722)
NCT ID: NCT02438722
Last Updated: 2026-05-18
Results Overview
Percentage of participants still alive 2 years post registration. KM estimate at 2 years is presented, Overall Survival assessed for a total of 3 years in order to calculate value.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
174 participants
Primary outcome timeframe
Up to 3 years post registration
Results posted on
2026-05-18
Participant Flow
174 participants were enrolled, however, 6 were deemed ineligible. Thus, 168 participants were eligible and randomized. 5 participants on arm 1 did not receive protocol therapy.
Participant milestones
| Measure |
Arm I (Afatinib Dimaleate, Cetuximab)
Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Afatinib Dimaleate)
Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
85
|
|
Overall Study
Participants evaluable for Adverse events
|
78
|
85
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
83
|
85
|
Reasons for withdrawal
| Measure |
Arm I (Afatinib Dimaleate, Cetuximab)
Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Afatinib Dimaleate)
Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
9
|
|
Overall Study
Refusal unrelated to AE
|
2
|
5
|
|
Overall Study
Disease progression/relapse
|
46
|
51
|
|
Overall Study
Death
|
0
|
3
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Exceeded protocol-specified maximum treatment delay unrelated to AE
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
On protocol treatment
|
15
|
14
|
|
Overall Study
Did not receive protocol treatment
|
5
|
0
|
Baseline Characteristics
S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Afatinib Dimaleate, Cetuximab)
n=83 Participants
Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Afatinib Dimaleate)
n=85 Participants
Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
n=11 Participants
|
66.3 years
n=9 Participants
|
66.0 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=11 Participants
|
53 Participants
n=9 Participants
|
112 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=11 Participants
|
32 Participants
n=9 Participants
|
56 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=11 Participants
|
10 Participants
n=9 Participants
|
21 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=11 Participants
|
8 Participants
n=9 Participants
|
11 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Native American
|
2 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
White
|
59 Participants
n=11 Participants
|
63 Participants
n=9 Participants
|
122 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
7 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
10 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 Participants
n=11 Participants
|
8 Participants
n=9 Participants
|
17 Participants
n=20 Participants
|
|
Performance status
0
|
38 Participants
n=11 Participants
|
32 Participants
n=9 Participants
|
70 Participants
n=20 Participants
|
|
Performance status
1
|
36 Participants
n=11 Participants
|
47 Participants
n=9 Participants
|
83 Participants
n=20 Participants
|
|
Performance status
2
|
9 Participants
n=11 Participants
|
6 Participants
n=9 Participants
|
15 Participants
n=20 Participants
|
|
EGFR mutation type
Exon 19 deletion
|
53 Participants
n=11 Participants
|
54 Participants
n=9 Participants
|
107 Participants
n=20 Participants
|
|
EGFR mutation type
L858R mutation
|
30 Participants
n=11 Participants
|
31 Participants
n=9 Participants
|
61 Participants
n=20 Participants
|
|
Histology
Adenocarcinoma
|
80 Participants
n=11 Participants
|
81 Participants
n=9 Participants
|
161 Participants
n=20 Participants
|
|
Histology
Large cell
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Histology
Squamous
|
3 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=20 Participants
|
|
Histology
Mixed (>= 50% squamous)
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Histology
Mixed (< 50% squamous)
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Histology
Other non-small cell
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Smoking history
Current smoker
|
8 Participants
n=11 Participants
|
6 Participants
n=9 Participants
|
14 Participants
n=20 Participants
|
|
Smoking history
Former smoker
|
32 Participants
n=11 Participants
|
32 Participants
n=9 Participants
|
64 Participants
n=20 Participants
|
|
Smoking history
Never smoker
|
43 Participants
n=11 Participants
|
47 Participants
n=9 Participants
|
90 Participants
n=20 Participants
|
|
Weight loss in the last 6 months, %
<5
|
57 Participants
n=11 Participants
|
57 Participants
n=9 Participants
|
114 Participants
n=20 Participants
|
|
Weight loss in the last 6 months, %
5-10
|
13 Participants
n=11 Participants
|
15 Participants
n=9 Participants
|
28 Participants
n=20 Participants
|
|
Weight loss in the last 6 months, %
10-20
|
12 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
21 Participants
n=20 Participants
|
|
Weight loss in the last 6 months, %
>=20
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Weight loss in the last 6 months, %
Data Missing
|
1 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=20 Participants
|
|
Brain metastases
|
27 Participants
n=11 Participants
|
21 Participants
n=9 Participants
|
48 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years post registrationPopulation: Eligible participants that were randomized to study arms.
Percentage of participants still alive 2 years post registration. KM estimate at 2 years is presented, Overall Survival assessed for a total of 3 years in order to calculate value.
Outcome measures
| Measure |
Arm I (Afatinib Dimaleate, Cetuximab)
n=83 Participants
Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Afatinib Dimaleate)
n=85 Participants
Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
2-year Overall Survival Rate
|
67 percentage of participants
Interval 55.0 to 76.0
|
70 percentage of participants
Interval 58.0 to 79.0
|
PRIMARY outcome
Timeframe: up to 3 years post registrationPopulation: Eligible participants that were randomized to study arms.
From date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration.
Outcome measures
| Measure |
Arm I (Afatinib Dimaleate, Cetuximab)
n=83 Participants
Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Afatinib Dimaleate)
n=85 Participants
Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Progression-Free Survival
|
11.9 months
Interval 9.9 to 17.8
|
13.4 months
Interval 9.3 to 14.9
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Eligible participants that were randomized to study arms and who had baseline measurable disease (153)
Percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of appropriate diameters of all target measurable lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm I (Afatinib Dimaleate, Cetuximab)
n=76 Participants
Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Afatinib Dimaleate)
n=77 Participants
Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Response Rates
|
67 percentage of participants
Interval 55.0 to 77.0
|
74 percentage of participants
Interval 63.0 to 83.0
|
SECONDARY outcome
Timeframe: up to 3 years post-registrationPopulation: Eligible participants who were randomized to study arms.
From date of registration to date of discontinuation of treatment or death due to any cause
Outcome measures
| Measure |
Arm I (Afatinib Dimaleate, Cetuximab)
n=83 Participants
Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Afatinib Dimaleate)
n=85 Participants
Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Time to Treatment Discontinuation
|
12.7 months
Interval 10.8 to 17.6
|
12.2 months
Interval 9.3 to 15.1
|
SECONDARY outcome
Timeframe: assessed up to 3 years post registrationPopulation: Eligible participants who were randomized to study arms.
From date of registration to date of first documentation of progression or symptomatic deterioration, early discontinuation of treatment, or death due to any cause.
Outcome measures
| Measure |
Arm I (Afatinib Dimaleate, Cetuximab)
n=83 Participants
Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Afatinib Dimaleate)
n=85 Participants
Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Time to Treatment Failure
|
10.8 months
Interval 7.7 to 12.9
|
10.0 months
Interval 7.1 to 13.5
|
SECONDARY outcome
Timeframe: Duration of treatment and follow up until death or 3 years post registrationPopulation: Patients who received at least one dose of protocol treatment.
Routine Adverse Events are reported by CTCAE4.0. For serious adverse event reporting, we updated from CTCAE4.0 to CTCAE5.0. . Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Arm I (Afatinib Dimaleate, Cetuximab)
n=78 Participants
Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Afatinib Dimaleate)
n=85 Participants
Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Creatinine increased
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
2 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
12 Participants
|
17 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dry skin
|
3 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anemia
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bullous dermatitis
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Chills
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cough
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Enterocolitis infectious
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Flank pain
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash maculo-papular
|
10 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash pustular
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sepsis
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Skin and subcutaneous tissue disorders - Other
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Skin infection
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thromboembolic event
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urticaria
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight loss
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
General disorders and admin site conditions - Other
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypocalcemia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypokalemia
|
5 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypomagnesemia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypophosphatemia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoxia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis oral
|
6 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
2 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Oral pain
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Palmar-plantar erythrodysesthesia syndrome
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Papulopustular rash
|
2 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Paronychia
|
4 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pneumonitis
|
3 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pruritus
|
3 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash acneiform
|
21 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count increased
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Aspartate aminotransferase increased
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Atrial fibrillation
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Back pain
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspepsia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea
|
2 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Encephalopathy
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infections and infestations - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infusion related reaction
|
2 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lipase increased
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lung infection
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
1 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Abdominal pain
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acidosis
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acute kidney injury
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alanine aminotransferase increased
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alkaline phosphatase increased
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Allergic reaction
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 years (after disease progression)For each of these markers, a one-sample t-test (or Wilcoxon signed-rank test) will be used to test the null hypothesis that the absolute difference between the copy number after progression and the copy number in the pre-treatment specimen (or an appropriate transformation of the difference, determined after exploratory data analysis) is not equal to zero.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 years (at progression)To evaluate if EGFRs/EGFR T790M is lower at progression than in pre-treatment specimens among patients with results available for pre-treatment and progression, a one-sample t-test (or Wilcoxon signed-rank test) will be used to test the null hypothesis that the difference between the progression ratio and the pre-treatment ratio (or an appropriate transformation of the difference, determined after exploratory data analysis) is greater than zero in favor of the alternative that the difference is less than zero.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineTo evaluate the hypothesis that H-score positive status at baseline is associated with absolute difference in PFS (and OS) among patients randomized to receive afatinib dimaleate monotherapy a test of interaction will be performed at the 1-sided 20% level.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsTumor marker levels over time will be evaluated using a linear mixed model for continuous markers and using generalized estimating equations for binary markers. A landmark analysis will be used to evaluate the correlation between post-randomization biomarker values and PFS and OS (from the landmark timepoint) using a Cox proportional hazards model.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineTo evaluate if the presence of de novo T790M mutation is associated with primary resistance to afatinib dimaleate, PFS and OS will be compared between T790M mutation positive and negative patients randomized to the afatinib dimaleate monotherapy arm using a log-rank test..
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsTo evaluate if the ratio of EGFR sensitizing mutation to EGFR T790M mutation (EGFRs/EGFR T790M) among patients with T790M is predictive for afatinib dimaleate monotherapy, analyses will be performed in a similar fashion to the evaluation of T790M among patients with measurable T790M (which defines T790M). Cox regression will be used to assess the predictive association of the ratio in the afatinib dimaleate monotherapy arm with both OS and PFS
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Afatinib Dimaleate, Cetuximab)
Serious events: 29 serious events
Other events: 78 other events
Deaths: 30 deaths
Arm II (Afatinib Dimaleate)
Serious events: 30 serious events
Other events: 84 other events
Deaths: 35 deaths
Serious adverse events
| Measure |
Arm I (Afatinib Dimaleate, Cetuximab)
n=78 participants at risk
Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Afatinib Dimaleate)
n=85 participants at risk
Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Cardiac disorders
Pericardial effusion
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
8.2%
7/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Mucositis oral
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
4.7%
4/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Death NOS
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Multi-organ failure
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Pain
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Immune system disorders
Allergic reaction
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Appendicitis
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Catheter related infection
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Infections and infestations-Other
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Lung infection
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Paronychia
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Sepsis
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Skin infection
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Alkaline phosphatase increased
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Blood bilirubin increased
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Creatinine increased
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Lymphocyte count decreased
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Weight loss
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Acidosis
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
5.9%
5/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Dysarthria
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
4.7%
4/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Headache
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Lethargy
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Nervous system disorders-Other
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Paresthesia
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Seizure
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Stroke
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Psychiatric disorders
Anxiety
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Psychiatric disorders
Depression
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Hematuria
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Vascular disorders
Hypertension
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Vascular disorders
Hypotension
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Vascular disorders
Thromboembolic event
|
6.4%
5/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
Other adverse events
| Measure |
Arm I (Afatinib Dimaleate, Cetuximab)
n=78 participants at risk
Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (Afatinib Dimaleate)
n=85 participants at risk
Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Afatinib Dimaleate: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
35.9%
28/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
37.6%
32/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
5.1%
4/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
4.7%
4/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Cardiac disorders
Cardiac disorders-Other
|
5.1%
4/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Cardiac disorders
Palpitations
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Cardiac disorders
Sinus tachycardia
|
5.1%
4/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
7.1%
6/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders - Other
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders-Other
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Ear and labyrinth disorders
Ear pain
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
5.9%
5/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Ear and labyrinth disorders
External ear inflammation
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Endocrine disorders
Endocrine disorders-Other
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Eye disorders
Blurred vision
|
14.1%
11/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
10.6%
9/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Eye disorders
Cataract
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Eye disorders
Conjunctivitis
|
16.7%
13/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
8.2%
7/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Eye disorders
Corneal ulcer
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Eye disorders
Dry eye
|
24.4%
19/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
17.6%
15/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Eye disorders
Eye disorders-Other
|
11.5%
9/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
11.8%
10/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Eye disorders
Eye pain
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Eye disorders
Eyelid function disorder
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Eye disorders
Floaters
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Eye disorders
Keratitis
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Eye disorders
Photophobia
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Eye disorders
Watering eyes
|
11.5%
9/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
10.6%
9/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
13/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
10.6%
9/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Bloating
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Cheilitis
|
7.7%
6/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
9.4%
8/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Constipation
|
39.7%
31/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
20.0%
17/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
93.6%
73/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
91.8%
78/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Dry mouth
|
12.8%
10/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
16.5%
14/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.3%
8/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
9.4%
8/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
9.4%
8/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Esophageal pain
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Esophagitis
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Flatulence
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.3%
8/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
9.4%
8/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
10.3%
8/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
11.8%
10/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Gingival pain
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Mucositis oral
|
48.7%
38/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
45.9%
39/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Nausea
|
56.4%
44/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
40.0%
34/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Oral pain
|
5.1%
4/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Periodontal disease
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Stomach pain
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
4.7%
4/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Tooth discoloration
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Toothache
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Gastrointestinal disorders
Vomiting
|
39.7%
31/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
24.7%
21/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Chills
|
14.1%
11/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
4.7%
4/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Edema face
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Edema limbs
|
19.2%
15/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
20.0%
17/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Fatigue
|
74.4%
58/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
57.6%
49/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Fever
|
12.8%
10/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
9.4%
8/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Flu like symptoms
|
9.0%
7/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
9.4%
8/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Gait disturbance
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
General disorders and admin site conditions - Other
|
14.1%
11/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
10.6%
9/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Infusion related reaction
|
9.0%
7/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Infusion site extravasation
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Irritability
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Localized edema
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Malaise
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Neck edema
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Non-cardiac chest pain
|
9.0%
7/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
8.2%
7/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
General disorders
Pain
|
25.6%
20/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
16.5%
14/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Hepatobiliary disorders
Hepatobiliary disorders-Other
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Immune system disorders
Allergic reaction
|
6.4%
5/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Immune system disorders
Immune system disorders-Other
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Bronchial infection
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Conjunctivitis infective
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Enterocolitis infectious
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Eye infection
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Infections and infestations-Other
|
14.1%
11/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
20.0%
17/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Laryngitis
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Lung infection
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Mucosal infection
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Nail infection
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Otitis media
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Papulopustular rash
|
9.0%
7/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
5.9%
5/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Paronychia
|
50.0%
39/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
40.0%
34/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Pelvic infection
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Rash pustular
|
5.1%
4/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Rhinitis infective
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Sinusitis
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
8.2%
7/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Skin infection
|
12.8%
10/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
9.4%
8/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Upper respiratory infection
|
9.0%
7/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
7.1%
6/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Urinary tract infection
|
12.8%
10/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
18.8%
16/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Vaginal infection
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Infections and infestations
Wound infection
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Fall
|
6.4%
5/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Injury, poison and procedural complications - Other
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Alanine aminotransferase increased
|
26.9%
21/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
28.2%
24/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Alkaline phosphatase increased
|
28.2%
22/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
27.1%
23/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Aspartate aminotransferase increased
|
34.6%
27/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
27.1%
23/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Blood bilirubin increased
|
11.5%
9/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
10.6%
9/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Cholesterol high
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Creatinine increased
|
17.9%
14/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
24.7%
21/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
INR increased
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Investigations-Other
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
10.6%
9/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Lipase increased
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Lymphocyte count decreased
|
23.1%
18/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
16.5%
14/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Lymphocyte count increased
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Neutrophil count decreased
|
5.1%
4/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
5.9%
5/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Platelet count decreased
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
7.1%
6/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Weight gain
|
7.7%
6/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
5.9%
5/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
Weight loss
|
28.2%
22/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
34.1%
29/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Investigations
White blood cell decreased
|
16.7%
13/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
11.8%
10/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Anorexia
|
38.5%
30/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
36.5%
31/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
6/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
4.7%
4/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.8%
17/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
23.5%
20/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.0%
7/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
5.9%
5/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
9.0%
7/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
32.1%
25/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
22.4%
19/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
26.9%
21/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
14.1%
12/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.1%
4/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
39.7%
31/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
23.5%
20/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
53.8%
42/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
21.2%
18/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.4%
12/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
21.2%
18/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.1%
4/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
7.7%
6/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
6/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
5.9%
5/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
29.5%
23/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
16.5%
14/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
6/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
4.7%
4/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.7%
6/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
4.7%
4/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
6/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
10.6%
9/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.1%
4/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
12.8%
10/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
17.6%
15/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
8/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
9.4%
8/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.0%
7/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.9%
21/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
21.2%
18/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
5.9%
5/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Ataxia
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Cognitive disturbance
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Concentration impairment
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Dizziness
|
23.1%
18/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
15.3%
13/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Dysgeusia
|
21.8%
17/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
23.5%
20/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Headache
|
29.5%
23/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
25.9%
22/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Memory impairment
|
9.0%
7/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Nervous system disorders-Other
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Paresthesia
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.3%
8/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
10.6%
9/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Presyncope
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Spasticity
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Nervous system disorders
Tremor
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Psychiatric disorders
Agitation
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Psychiatric disorders
Anxiety
|
17.9%
14/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
7.1%
6/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Psychiatric disorders
Confusion
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
5.9%
5/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Psychiatric disorders
Depression
|
12.8%
10/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
4.7%
4/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Psychiatric disorders
Insomnia
|
16.7%
13/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
11.8%
10/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Psychiatric disorders
Libido decreased
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Psychiatric disorders
Psychiatric disorders-Other
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Psychiatric disorders
Restlessness
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Psychiatric disorders
Suicide attempt
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Bladder spasm
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Hematuria
|
6.4%
5/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Proteinuria
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
5.1%
4/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Renal calculi
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Renal colic
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Urinary frequency
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Urinary tract pain
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Renal and urinary disorders
Urinary urgency
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
20.5%
16/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
10.6%
9/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
46.2%
36/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
42.4%
36/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
26/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
27.1%
23/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
28.2%
22/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
23.5%
20/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
13/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
9.4%
8/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.4%
5/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
7.1%
6/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.3%
8/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
5.9%
5/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
12.8%
10/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
14.1%
11/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
14.1%
12/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.3%
8/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
13/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
15.3%
13/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
61.5%
48/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
43.5%
37/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
4.7%
4/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
10.3%
8/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
6.4%
5/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
9.4%
8/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
9.0%
7/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
7.1%
6/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
10.3%
8/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
11.8%
10/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
17.9%
14/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
10.6%
9/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
41.0%
32/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
30.6%
26/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
79.5%
62/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
58.8%
50/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
46.2%
36/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
37.6%
32/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
43.6%
34/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
24.7%
21/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.1%
4/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Surgical and medical procedures
Surgical and medical procedures-Other
|
3.8%
3/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
2.4%
2/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Vascular disorders
Flushing
|
2.6%
2/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Vascular disorders
Hypertension
|
24.4%
19/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
31.8%
27/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Vascular disorders
Hypotension
|
10.3%
8/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
1.2%
1/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Vascular disorders
Thromboembolic event
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
3.5%
3/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
|
Vascular disorders
Vascular disorders-Other
|
1.3%
1/78 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
0.00%
0/85 • Duration of treatment and follow up until death or 3 years post registration
Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
|
Additional Information
Lung Committee Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place