Trial Outcomes & Findings for Avastin +/- Erlotinib Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Advanced Ovarian, Fallopian Tube, Primary Peritoneal Cancer & Papillary Serous or Clear Cell Mullerian Tumors (NCT NCT00520013)
NCT ID: NCT00520013
Last Updated: 2018-07-27
Results Overview
Consolidation PFS based on the Kaplan-Meier method was defined as the time from the first day of consolidation therapy to documented disease progression (PD) or disease-specific death. Based on RECIST 1.1, radiographic PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning consolidation, the appearence of one or more new lesions and/or unequivocal progression of existing non-target lesions. Based on Rustin criteria, serlogic PD was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to \>/= 2xULN with either event documented on 2 occasions. Patients who were event-free were censored at the date of their last disease evaluation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year and upon treatment discontinuation were followed for another year.
Results posted on
2018-07-27
Participant Flow
Sixty patients were enrolled between Aug 3, 2007 and Jan 6, 2010.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Participant milestones
| Measure |
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.
|
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.
|
Carboplatin/Paclitaxel/Bevacizumab
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation: None
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
25
|
11
|
|
Overall Study
Treated
|
23
|
25
|
11
|
|
Overall Study
COMPLETED
|
11
|
10
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
11
|
Reasons for withdrawal
| Measure |
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.
|
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.
|
Carboplatin/Paclitaxel/Bevacizumab
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation: None
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
2
|
10
|
7
|
|
Overall Study
Progressive Disease
|
7
|
3
|
0
|
|
Overall Study
Clinical Progression
|
3
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
3
|
Baseline Characteristics
Avastin +/- Erlotinib Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Advanced Ovarian, Fallopian Tube, Primary Peritoneal Cancer & Papillary Serous or Clear Cell Mullerian Tumors
Baseline characteristics by cohort
| Measure |
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab
n=23 Participants
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.
bevacizumab
paclitaxel
carboplatin
|
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
n=25 Participants
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.
bevacizumab
erlotinib
paclitaxel
carboplatin
|
Carboplatin/Paclitaxel/Bevacizumab
n=11 Participants
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation: None
bevacizumab
paclitaxel
carboplatin
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58 years
n=99 Participants
|
56 years
n=107 Participants
|
54 years
n=206 Participants
|
57 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
25 participants
n=107 Participants
|
11 participants
n=206 Participants
|
59 participants
n=7 Participants
|
|
Cancer Type
Primary peritoneal
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Cancer Type
Fallopian tube
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
1 participants
n=206 Participants
|
10 participants
n=7 Participants
|
|
Cancer Type
Epithelial ovarian
|
10 participants
n=99 Participants
|
17 participants
n=107 Participants
|
8 participants
n=206 Participants
|
35 participants
n=7 Participants
|
|
Cancer Type
Uterine papillary serous
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Cancer Type
Other (mixed, carcinosarcoma)
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
4 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year and upon treatment discontinuation were followed for another year.Population: The analysis dataset is comprised of patients randomized to consolidation treatment.
Consolidation PFS based on the Kaplan-Meier method was defined as the time from the first day of consolidation therapy to documented disease progression (PD) or disease-specific death. Based on RECIST 1.1, radiographic PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning consolidation, the appearence of one or more new lesions and/or unequivocal progression of existing non-target lesions. Based on Rustin criteria, serlogic PD was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to \>/= 2xULN with either event documented on 2 occasions. Patients who were event-free were censored at the date of their last disease evaluation.
Outcome measures
| Measure |
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab
n=23 Participants
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.
|
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
n=25 Participants
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.
|
|---|---|---|
|
Consolidation Progression-Free Survival
|
13.3 months
Interval 10.1 to
PFS data was not mature enough to provide an upper bound on 95% CI. Also note per design each arm was separately compared to a historical control \[PMID:7494563\].
|
18.9 months
Interval 15.4 to
PFS data was not mature enough to provide an upper bound on 95% CI. Also note per design each arm was separately compared to a historical control \[PMID:7494563\].
|
PRIMARY outcome
Timeframe: Assessed every cycle during consolidation treatment and up to 30 days post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.Population: The analysis dataset is comprised of patients who were randomized to consolidation treatment.
Consolidation treatment-related toxicity rates based on CTCAEv3 were defined as rates of maximum grade 3 or higher toxicity events with attribution possible, probable or definite occurring during consolidation treatment and up to 30 days post-treatment.
Outcome measures
| Measure |
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab
n=23 Participants
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.
|
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
n=25 Participants
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.
|
|---|---|---|
|
Consolidation Treatment-related Toxicity Rate
|
30.4 percentage of participants
Interval 13.2 to 52.9
|
72.0 percentage of participants
Interval 50.6 to 88.0
|
SECONDARY outcome
Timeframe: Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year.Population: The analysis dataset is comprised of all patient who started consolidation treatment.
Consolidation objective response (OR) was based on RECIST 1.0 criteria with OR defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. If CA125 disease then OR based on Rustin criteria is a 50% decrease in serum CA125 level from two initially elevated samples confirmed by a 4th sample.
Outcome measures
| Measure |
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab
n=23 Participants
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.
|
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
n=25 Participants
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.
|
|---|---|---|
|
Consolidation Objective Response Rate
|
0.65 proportion of patients
Interval 0.43 to 0.84
|
.60 proportion of patients
Interval 0.39 to 0.79
|
Adverse Events
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab
Serious events: 7 serious events
Other events: 23 other events
Deaths: 0 deaths
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
Serious events: 18 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab
n=23 participants at risk
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.
|
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
n=25 participants at risk
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
20.0%
5/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
General disorders
Fatigue
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Infections and infestations
Infection-other
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Injury, poisoning and procedural complications
Wound - non-infectious
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Reproductive system and breast disorders
Irregular menses
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
12.0%
3/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Vascular disorders
Hypertension
|
26.1%
6/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
16.0%
4/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Vascular disorders
Hemorrhage-other
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
Other adverse events
| Measure |
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab
n=23 participants at risk
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.
|
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
n=25 participants at risk
Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.
Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.
|
|---|---|---|
|
Gastrointestinal disorders
Abdomen, pain
|
13.0%
3/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
8.0%
2/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
52.2%
12/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
44.0%
11/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Investigations
ALT, SGPT
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.7%
2/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
20.0%
5/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Psychiatric disorders
Anxiety
|
21.7%
5/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
8.0%
2/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Investigations
AST, SGOT
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
8.0%
2/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Metabolism and nutrition disorders
Bicarbonate
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Investigations
Bilirubin
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Renal and urinary disorders
Bladder, pain
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Injury, poisoning and procedural complications
Chemoradiation dermatitis
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
General disorders
Chest/thoracic pain NOS
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Constipation
|
21.7%
5/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
24.0%
6/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
General disorders
Constitutional, other
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Cardiac disorders
C-P arrest, non-fatal, cause unk
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Dental/teeth/peridontal
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Psychiatric disorders
Depression
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
21.7%
5/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
72.0%
18/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
44.0%
11/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.0%
3/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.7%
2/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
General disorders
Edema limb
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
12.0%
3/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
8.7%
2/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
20.0%
5/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
General disorders
Face, pain
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
General disorders
Fatigue
|
78.3%
18/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
84.0%
21/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
General disorders
Fever w/o neutropenia
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
8.0%
2/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
GI-other
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
12.0%
3/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Nervous system disorders
Head/headache
|
26.1%
6/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
16.0%
4/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
34.8%
8/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
32.0%
8/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Vascular disorders
Hemorrhage-other
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
12.0%
3/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.4%
4/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
8.0%
2/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Vascular disorders
Hypertension
|
39.1%
9/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
36.0%
9/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
30.4%
7/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
32.0%
8/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.7%
2/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
12.0%
3/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Vascular disorders
Hypotension
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Infections and infestations
Infection Gr0-2 neut, lip/perioral
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Infections and infestations
Infection Gr0-2 neut, meninges
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Infections and infestations
Infection Gr0-2 neut, wound
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Infections and infestations
Infection w/ gr3-4 neut, anal/perianal
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Infections and infestations
Infection w/ gr3-4 neut, skin
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Infections and infestations
Infection w/ unk ANC ungual (nails)
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
8.0%
2/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Infections and infestations
Infection-other
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Psychiatric disorders
Insomnia
|
8.7%
2/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Intestine, pain
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
52.2%
12/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
28.0%
7/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
12.0%
3/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Investigations
Leukocytes
|
13.0%
3/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
20.0%
5/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Psychiatric disorders
Libido
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Lip, pain
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Blood and lymphatic system disorders
Lymphatics-other
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Investigations
Metabolic/Laboratory-other
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
16.0%
4/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) stomach
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
8.0%
2/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
26.1%
6/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
16.0%
4/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
8.0%
2/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
12.0%
3/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Nausea
|
21.7%
5/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
36.0%
9/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Musculoskeletal and connective tissue disorders
Neck, pain
|
8.7%
2/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Nervous system disorders
Neurologic-other
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Nervous system disorders
Neuropathy-motor
|
8.7%
2/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
12.0%
3/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Nervous system disorders
Neuropathy-sensory
|
60.9%
14/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
48.0%
12/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Investigations
Neutrophils
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
20.0%
5/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic upper extr muscle weak
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
8.0%
2/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
56.5%
13/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
28.0%
7/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Oral cavity, hemorrhage
|
13.0%
3/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Oral cavity, pain
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
12.0%
3/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Oral gums, pain
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
General disorders
Pain-other
|
8.7%
2/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Investigations
Platelets
|
21.7%
5/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Renal and urinary disorders
Proteinuria
|
17.4%
4/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
8.0%
2/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
20.0%
5/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
32.0%
8/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
64.0%
16/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Rectum, hemorrhage
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Renal and urinary disorders
Renal/GU-other
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
General disorders
Rigors/chills
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
8.0%
2/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Salivary
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Skin, pain
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
16.0%
4/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Nervous system disorders
Sinus, pain
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Nervous system disorders
Taste disturbance
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
12.0%
3/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynax, pain
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Renal and urinary disorders
Urinary hemorrhage NOS
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.3%
1/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Reproductive system and breast disorders
Vagina, hemorrhage
|
8.7%
2/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
8.7%
2/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
12.0%
3/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Eye disorders
Vision-blurred
|
8.7%
2/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
0.00%
0/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
|
Investigations
Weight loss
|
0.00%
0/23 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
4.0%
1/25 • Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place