Trial Outcomes & Findings for Schedules of Nab-Paclitaxel in Metastatic Breast Cancer (NCT NCT01746225)
NCT ID: NCT01746225
Last Updated: 2023-06-01
Results Overview
Time from randomization until objective disease progression \[progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions\] or death, whichever occurs first. For patients without progression, follow-up was censored at the date of last disease assessment without progression, unless death occurred within a short period of time (12 weeks) following the date last known progression-free, in which case the death was counted as a PFS event.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
258 participants
Primary outcome timeframe
Reported after 18.2 months median follow-up since randomization
Results posted on
2023-06-01
Participant Flow
255 patients were randomized between 16April2013 and 7August2015 at 35 centers in 5 countries.
Participant milestones
| Measure |
B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15
Arm B: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Arm C: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
A: Nab-Paclitaxel 150 mg/m2 Days 1,15
Arm A: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
|---|---|---|---|
|
Overall Study
STARTED
|
86
|
86
|
83
|
|
Overall Study
COMPLETED
|
40
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
46
|
43
|
40
|
Reasons for withdrawal
| Measure |
B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15
Arm B: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Arm C: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
A: Nab-Paclitaxel 150 mg/m2 Days 1,15
Arm A: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
15
|
19
|
5
|
|
Overall Study
Physician Decision
|
11
|
3
|
14
|
|
Overall Study
Adverse Event
|
12
|
17
|
15
|
|
Overall Study
Continuing Treatment
|
8
|
3
|
5
|
Baseline Characteristics
Schedules of Nab-Paclitaxel in Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
A: Nab-Paclitaxel 150 mg/m2 Days 1,15
n=83 Participants
Arm A: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
|
B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15
n=86 Participants
Arm B: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
|
C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
n=86 Participants
Arm C: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
56 years
n=7 Participants
|
60 years
n=5 Participants
|
58 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
255 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
83 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Region of Enrollment
Ireland
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
18 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
12 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Region of Enrollment
Slovenia
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
Switzerland
|
20 participants
n=5 Participants
|
25 participants
n=7 Participants
|
29 participants
n=5 Participants
|
75 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
17 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
ER Status
Positive
|
72 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
210 Participants
n=4 Participants
|
|
ER Status
Negative
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Prior Taxanes
Yes
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Prior Taxanes
No
|
57 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Type of Radiologically Evaluable Disease
Measurable
|
68 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
210 Participants
n=4 Participants
|
|
Type of Radiologically Evaluable Disease
Non-measurable only
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Reported after 18.2 months median follow-up since randomizationPopulation: Intention-to-treat population
Time from randomization until objective disease progression \[progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions\] or death, whichever occurs first. For patients without progression, follow-up was censored at the date of last disease assessment without progression, unless death occurred within a short period of time (12 weeks) following the date last known progression-free, in which case the death was counted as a PFS event.
Outcome measures
| Measure |
A: Nab-Paclitaxel 150 mg/m2 Days 1,15
n=83 Participants
Arm A: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15
n=86 Participants
Arm B: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
n=86 Participants
Arm C: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
|---|---|---|---|
|
Progression-free Survival
|
7.9 months
Interval 6.8 to 8.4
|
9.0 months
Interval 8.1 to 10.9
|
8.5 months
Interval 6.7 to 9.5
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks follow-upPopulation: Intention to treat population
Whether or not the patient completed treatment according to the protocol for at least 24 weeks. Patients who progressed within 24 weeks were considered as not completing.
Outcome measures
| Measure |
A: Nab-Paclitaxel 150 mg/m2 Days 1,15
n=83 Participants
Arm A: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15
n=86 Participants
Arm B: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
n=86 Participants
Arm C: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
|---|---|---|---|
|
Feasibility of Treatment: Number of Participants Completed Treatment According to the Protocol for at Least 24 Weeks
|
40 Participants
|
43 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 monthsPopulation: Intention to treat population
Overall response of stable disease (or non-CR/non-PD for patients with non-measurable disease) for a duration of ≥24 weeks, or better (i.e., partial or complete response) according to RECIST criteria \[Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.\]
Outcome measures
| Measure |
A: Nab-Paclitaxel 150 mg/m2 Days 1,15
n=83 Participants
Arm A: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15
n=86 Participants
Arm B: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
n=86 Participants
Arm C: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
|---|---|---|---|
|
Disease Control: Overall Response of Stable Disease for a Duration of ≥24 Weeks
|
54 Participants
|
59 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 monthsPopulation: Intention to treat population
Best response according to RECIST 1.1 criteria \[assessed by MRI\] recorded from the start of treatment across all time points until end of study treatment. Confirmation of partial or complete response by an additional scan was not requested in this trial.
Outcome measures
| Measure |
A: Nab-Paclitaxel 150 mg/m2 Days 1,15
n=83 Participants
Arm A: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15
n=86 Participants
Arm B: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
n=86 Participants
Arm C: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
|---|---|---|---|
|
Best Overall Response
Complete Response (CR)
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Best Overall Response
Partial Response (PR)
|
34 Participants
|
41 Participants
|
35 Participants
|
|
Best Overall Response
Stable Disease (SD)/Non-CR/Non-PD
|
39 Participants
|
33 Participants
|
31 Participants
|
|
Best Overall Response
Progressive Disease (PD)
|
3 Participants
|
5 Participants
|
11 Participants
|
|
Best Overall Response
Not Evaluable (NE)
|
2 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Reported after 18.2 months median follow-up since randomizationPopulation: Intention to treat population
Time from randomization until death from any cause, or censored at date last known alive
Outcome measures
| Measure |
A: Nab-Paclitaxel 150 mg/m2 Days 1,15
n=83 Participants
Arm A: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15
n=86 Participants
Arm B: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
n=86 Participants
Arm C: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
|---|---|---|---|
|
Overall Survival
|
25.8 months
Interval 16.9 to
Not reported, insufficient number of participants with events.
|
26.2 months
Interval 21.0 to
Not reported, insufficient number of participants with events.
|
25.5 months
Interval 22.7 to
Not reported, insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Assessed from day 1 of cycle 4 through day 1 of cycle 12Population: Patients who started the maintenance phase of treatment (cycle 4)
Primary quality of life=physical well being; endpoint based on the GLQ 8. The indicator was in Linear Analogue Self-Assessment (LASA) format ranging 0-100 (0=as bad as it can be, 100=as good as it can be).
Outcome measures
| Measure |
A: Nab-Paclitaxel 150 mg/m2 Days 1,15
n=66 Participants
Arm A: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15
n=72 Participants
Arm B: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
n=61 Participants
Arm C: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
|---|---|---|---|
|
Changes in Physical Well-being (Change From Day 1 of Cycle 4 to Day 1 of Cycle 6)
|
-2 units on a scale
Interval -9.0 to 5.0
|
1 units on a scale
Interval -6.0 to 7.0
|
4 units on a scale
Interval -4.0 to 11.0
|
Adverse Events
A: Nab-Paclitaxel 150 mg/m2 Days 1,15
Serious events: 51 serious events
Other events: 78 other events
Deaths: 0 deaths
B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15
Serious events: 43 serious events
Other events: 83 other events
Deaths: 0 deaths
C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Serious events: 57 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A: Nab-Paclitaxel 150 mg/m2 Days 1,15
n=83 participants at risk
Arm A: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15
n=86 participants at risk
Arm B: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
n=86 participants at risk
Arm C: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.0%
5/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
2.3%
2/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.4%
2/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
2.3%
2/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Eye disorders
Cataract
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Eye disorders
Dry eye
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Ascites
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Diarrhea
|
8.4%
7/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
3.5%
3/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
2.3%
2/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Ileal obstruction
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.4%
2/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
2/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Stomach pain
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
3.5%
3/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
General disorders
Edema limbs
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
General disorders
Fatigue
|
4.8%
4/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
4.7%
4/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
10.5%
9/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
General disorders
Fever
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
General disorders
Multi-organ failure
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
General disorders
Pain
|
3.6%
3/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
2.3%
2/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Infections and infestations
Appendicitis
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
2.3%
2/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Infections and infestations
Lung infection
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Infections and infestations
Nail infection
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Infections and infestations
Paronychia
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Infections and infestations
Rhinitis infective
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Infections and infestations
Sepsis
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
2.3%
2/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Infections and infestations
Skin infection
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Infections and infestations
Wound infection
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Investigations
Neutrophil count decreased
|
21.7%
18/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
27.9%
24/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
24.4%
21/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Investigations
Platelet count decreased
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Investigations
Alanine aminotransferase increased
|
3.6%
3/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Investigations
Alkaline phosphatase increased
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Investigations
Aspartate aminotransferase increased
|
3.6%
3/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Investigations
Creatinine increased
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Investigations
GGT increased
|
3.6%
3/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
2.3%
2/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Investigations
Weight gain
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Investigations
White blood cell decreased
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
3/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
2.3%
2/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective - Other
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
8.4%
7/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
4.7%
4/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
5.8%
5/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Nervous system disorders
Seizure
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Nervous system disorders
Spasticity
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Nervous system disorders
Syncope
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Psychiatric disorders
Depression
|
2.4%
2/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Reproductive system and breast disorders
Reproductive system and breast
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Reproductive system and breast disorders
Breast pain
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
2.3%
2/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory thoracic mediastinal - Other,10038738
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Vascular disorders
Hypertension
|
1.2%
1/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
5.8%
5/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
4.7%
4/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Vascular disorders
Thromboembolic event
|
3.6%
3/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
3.5%
3/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
4.7%
4/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
Other adverse events
| Measure |
A: Nab-Paclitaxel 150 mg/m2 Days 1,15
n=83 participants at risk
Arm A: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15
n=86 participants at risk
Arm B: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
n=86 participants at risk
Arm C: Induction\* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
\*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².
|
|---|---|---|---|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
61.4%
51/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
67.4%
58/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
64.0%
55/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Nervous system disorders
Recurrent Laryngeal nerve Palsy
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
1.2%
1/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Investigations
Neutrophil count decreased
|
33.7%
28/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
40.7%
35/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
48.8%
42/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Investigations
Platelet count decreased
|
9.6%
8/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
9.3%
8/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
4.7%
4/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Blood and lymphatic system disorders
Anemia
|
55.4%
46/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
64.0%
55/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
64.0%
55/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Nausea
|
38.6%
32/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
36.0%
31/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
46.5%
40/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
10/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
12.8%
11/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
19.8%
17/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Gastrointestinal disorders
Diarrhea
|
25.3%
21/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
32.6%
28/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
31.4%
27/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
0.00%
0/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
3.5%
3/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Cardiac disorders
Sinus Tachycardia
|
2.4%
2/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
4.7%
4/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
3.5%
3/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Immune system disorders
Allergic Reaction
|
9.6%
8/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
4.7%
4/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
4.7%
4/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
2/83 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
2.3%
2/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
4.7%
4/86 • Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
|
Additional Information
Heidi Roschitzki-Voser
International Breast Cancer Study Group (IBCSG)
Phone: +41 31 511 94 18
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place