Trial Outcomes & Findings for Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC (NCT NCT00880334)
NCT ID: NCT00880334
Last Updated: 2018-09-18
Results Overview
PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1.0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
COMPLETED
PHASE2
149 participants
Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment and every 3 months in follow-up. Participants were followed until PD, death or lost to follow-up. Median survival follow-up was 12 months (range 1-26).
2018-09-18
Participant Flow
Patients enrolled from February 2007 through May 2010.
There were 7 cancelled patients who were randomized but did not receive treatment.
Participant milestones
| Measure |
Vandetanib and Docetaxel
Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
|
Placebo and Docetaxel
Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
Eligible participants were allowed to crossover to single agent vandetanib.
|
|---|---|---|
|
Randomized Phase
STARTED
|
74
|
75
|
|
Randomized Phase
Eligible & Treated
|
70
|
72
|
|
Randomized Phase
COMPLETED
|
70
|
35
|
|
Randomized Phase
NOT COMPLETED
|
4
|
40
|
|
Crossover Phase
STARTED
|
0
|
37
|
|
Crossover Phase
COMPLETED
|
0
|
37
|
|
Crossover Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Vandetanib and Docetaxel
Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
|
Placebo and Docetaxel
Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
Eligible participants were allowed to crossover to single agent vandetanib.
|
|---|---|---|
|
Randomized Phase
Physician Decision
|
1
|
0
|
|
Randomized Phase
Withdrawal by Subject
|
2
|
1
|
|
Randomized Phase
Inadequate Labs
|
1
|
1
|
|
Randomized Phase
Brain Metastasis
|
0
|
1
|
|
Randomized Phase
Crossover Participants
|
0
|
37
|
Baseline Characteristics
Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC
Baseline characteristics by cohort
| Measure |
Vandetanib & Docetaxel
n=70 Participants
Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
|
Placebo and Docetaxel
n=72 Participants
Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment and every 3 months in follow-up. Participants were followed until PD, death or lost to follow-up. Median survival follow-up was 12 months (range 1-26).Population: The analysis dataset is comprised of all eligible and treated patients.
PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1.0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Vandetanib and Docetaxel
n=70 Participants
Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Vandetanib: taken orally once a day, every day
|
Placebo and Docetaxel
n=72 Participants
Placebo orally and docetaxel intravenously
Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Placebo: Taken orally once a day every day
|
|---|---|---|
|
Median Progression-Free Survival (PFS)
|
2.56 months
Interval 1.81 to 3.06
|
1.58 months
Interval 1.48 to 3.09
|
SECONDARY outcome
Timeframe: Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).Population: The analysis dataset is comprised of all eligible and treated patients.
Grade 3-5 toxicity rate is the percentage of participants experiencing maximum grade of all toxicity types of grade 3-5 with any attribution on treatment during the randomized phase.
Outcome measures
| Measure |
Vandetanib and Docetaxel
n=70 Participants
Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Vandetanib: taken orally once a day, every day
|
Placebo and Docetaxel
n=72 Participants
Placebo orally and docetaxel intravenously
Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Placebo: Taken orally once a day every day
|
|---|---|---|
|
Grade 3-5 Toxicity Rate
|
73 percentage of participants
Interval 61.0 to 83.0
|
57 percentage of participants
Interval 45.0 to 69.0
|
SECONDARY outcome
Timeframe: Off treatment, patients were followed for survival information every 6 months (±1 month) until death,up to 2 years after discontinuing therapy, or until lost to follow-up. Median survival follow-up for the study cohort was 12 months (95% CI: 9-18 months).Population: The analysis dataset is comprised of all eligible and treated patients.
Overall survival is defined from date of randomization to date of death or censored at the date the patient was last known alive.
Outcome measures
| Measure |
Vandetanib and Docetaxel
n=70 Participants
Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Vandetanib: taken orally once a day, every day
|
Placebo and Docetaxel
n=72 Participants
Placebo orally and docetaxel intravenously
Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Placebo: Taken orally once a day every day
|
|---|---|---|
|
Median Overall Survival
|
5.85 months
Interval 5.22 to 7.0
|
7.03 months
Interval 5.19 to 10.41
|
SECONDARY outcome
Timeframe: Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).Population: The analysis dataset is comprised of all eligible and treated patients.
Objective response rate is defined as the percentage of participants who achieved a confirmed overall partial response (PR) or complete response (CR) using RECIST criteria on treatment during the randomized phase. Patients without measurable disease only at baseline are included, based on status of non-target lesions.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. To be assigned a status of 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.
Outcome measures
| Measure |
Vandetanib and Docetaxel
n=70 Participants
Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Vandetanib: taken orally once a day, every day
|
Placebo and Docetaxel
n=72 Participants
Placebo orally and docetaxel intravenously
Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Placebo: Taken orally once a day every day
|
|---|---|---|
|
Objective Response Rate
|
7.1 percentage of participants
Interval 2.4 to 15.9
|
11.1 percentage of participants
Interval 4.9 to 20.8
|
POST_HOC outcome
Timeframe: Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).Disease control rate is defined as the percentage of participants with confirmed overall Stable Disease (SD) or better using RECIST 1.0 criteria which parallels absence of disease progression (PD) on treatment during the randomized phase. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients without measurable disease only at baseline are included, based on status of non-target lesions.
Outcome measures
| Measure |
Vandetanib and Docetaxel
n=70 Participants
Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Vandetanib: taken orally once a day, every day
|
Placebo and Docetaxel
n=72 Participants
Placebo orally and docetaxel intravenously
Docetaxel: Given intravenously on Day 1 of each 21-day cycle
Placebo: Taken orally once a day every day
|
|---|---|---|
|
Disease Control Rate
|
51 percentage of participants
Interval 39.0 to 64.0
|
42 percentage of participants
Interval 30.0 to 54.0
|
Adverse Events
Vandetanib and Docetaxel
Placebo and Docetaxel
Placebo and Docetaxel-Crossover
Serious adverse events
| Measure |
Vandetanib and Docetaxel
n=70 participants at risk
Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
|
Placebo and Docetaxel
n=72 participants at risk
Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
|
Placebo and Docetaxel-Crossover
n=37 participants at risk
Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
|
|---|---|---|---|
|
Immune system disorders
Allergic reaction
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Creatinine
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Depression
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
7.1%
5/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
5.4%
2/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fatigue
|
8.6%
6/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
5.6%
4/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
5.4%
2/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.8%
2/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
GI-other
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.3%
3/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypertension
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.1%
5/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
4.2%
3/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, bladder
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr 0-2 neut, blood
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ gr 3-4 neut, blood
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ gr3-4 neut, lung
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC bladder
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC peritoneal cavity
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Leukocytes
|
7.1%
5/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
9.7%
7/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Lymphopenia
|
5.7%
4/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neuropathy-sensory
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophils
|
14.3%
10/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
13.9%
10/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
4.3%
3/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
PTT
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
QTc interval
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.1%
5/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Syncope
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary retention
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Vascular access,Thrombosis/embolism
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Nausea
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary hemorrhage NOS
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
Other adverse events
| Measure |
Vandetanib and Docetaxel
n=70 participants at risk
Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
|
Placebo and Docetaxel
n=72 participants at risk
Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
|
Placebo and Docetaxel-Crossover
n=37 participants at risk
Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdomen, pain
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
3/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.3%
3/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Atrial flutter
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Bilirubin
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary, hemorrhage
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Constitutional, other
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
8.6%
6/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Dizziness
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Dry eye syndrome
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema head and neck
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema limb
|
4.3%
3/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema trunk/genital
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fatigue
|
12.9%
9/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
8.3%
6/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
8.1%
3/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fever w/o neutropenia
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Flatulence
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Flushing
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
GI-other
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Head/headache
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Hematologic-other
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypertension
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.7%
4/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, oral cavity
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ gr3-4 neut, bladder
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC skin (cellulitis)
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Insomnia
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Leukocytes
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Lymphopenia
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, stomach
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
4/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
4.2%
3/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neurologic-other
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neuropathy-motor
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neuropathy-sensory
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.8%
2/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Palpitations
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Pelvic, pain
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage NOS
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Rigors/chills
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Taste disturbance
|
4.3%
3/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
1.4%
1/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Tremor
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary hemorrhage NOS
|
2.9%
2/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Vision-blurred
|
1.4%
1/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
AST, SGOT
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
ALT, SGPT
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hemorrhage-other
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
0.00%
0/70 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/72 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Assessed each cycle throughout treatment on the randomized and crossover phases from time of first dose and up to day 30 post-treatment. Median treatment duration for the randomized study cohort was 2 cycles (range 1-31 cycles). Median treatment duration for the crossover study cohort was 2 cycles (range 1-23 cycles).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with vandetanib treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with vandetanib treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place