Trial Outcomes & Findings for Docetaxel With or Without AZD6244 in Melanoma (NCT NCT01256359)
NCT ID: NCT01256359
Last Updated: 2024-08-15
Results Overview
This is defined as time from date of randomisation to the first of date of progression (using CT scan, x-ray, MRI scan and clinical examination) using modified RECIST (v1.1) criteria or date of death (events). For patients without an event, the time from date of randomisation to date last known alive will be the censored PFS time.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.
Results posted on
2024-08-15
Participant Flow
Recruitment of 83 participants from 16 centres (hospitals) took place between October 2010 and May 2012. Participants attended clinic visits according to the protocol.
Participant milestones
| Measure |
Docetaxel and AZD6244
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
|
Overall Study
COMPLETED
|
38
|
41
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Docetaxel and AZD6244
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Overall Study
Randomised, later found to be ineligible and did not start treatment
|
1
|
1
|
|
Overall Study
Randomised and found to be too unwell to start treatment
|
2
|
0
|
Baseline Characteristics
Not all patients were evaluated for each abnormality
Baseline characteristics by cohort
| Measure |
Docetaxel and AZD6244
n=41 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=42 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 12.0 • n=41 Participants
|
59.2 years
STANDARD_DEVIATION 13.3 • n=42 Participants
|
59.3 years
STANDARD_DEVIATION 12.6 • n=83 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=41 Participants
|
15 Participants
n=42 Participants
|
25 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=41 Participants
|
27 Participants
n=42 Participants
|
58 Participants
n=83 Participants
|
|
Region of Enrollment
United Kingdom
|
41 Participants
n=41 Participants
|
42 Participants
n=42 Participants
|
83 Participants
n=83 Participants
|
|
Stage
M1c
|
33 Participants
n=41 Participants
|
32 Participants
n=42 Participants
|
65 Participants
n=83 Participants
|
|
Stage
M0 or M1a or M1b
|
8 Participants
n=41 Participants
|
10 Participants
n=42 Participants
|
18 Participants
n=83 Participants
|
|
ECOG Performance Score
0
|
28 Participants
n=41 Participants
|
34 Participants
n=42 Participants
|
62 Participants
n=83 Participants
|
|
ECOG Performance Score
1
|
13 Participants
n=41 Participants
|
8 Participants
n=42 Participants
|
21 Participants
n=83 Participants
|
|
Smoking status
Yes
|
4 Participants
n=41 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=83 Participants
|
|
Smoking status
No, but smoked in the past
|
22 Participants
n=41 Participants
|
27 Participants
n=42 Participants
|
49 Participants
n=83 Participants
|
|
Smoking status
Never smoked
|
15 Participants
n=41 Participants
|
12 Participants
n=42 Participants
|
27 Participants
n=83 Participants
|
|
Physical examination
General appearance
|
0 Participants
n=39 Participants • Not all patients were evaluated for each abnormality
|
1 Participants
n=42 Participants • Not all patients were evaluated for each abnormality
|
1 Participants
n=81 Participants • Not all patients were evaluated for each abnormality
|
|
Physical examination
Skin
|
21 Participants
n=41 Participants • Not all patients were evaluated for each abnormality
|
13 Participants
n=42 Participants • Not all patients were evaluated for each abnormality
|
34 Participants
n=83 Participants • Not all patients were evaluated for each abnormality
|
|
Physical examination
HEENT
|
1 Participants
n=36 Participants • Not all patients were evaluated for each abnormality
|
4 Participants
n=40 Participants • Not all patients were evaluated for each abnormality
|
5 Participants
n=76 Participants • Not all patients were evaluated for each abnormality
|
|
Physical examination
Chest
|
4 Participants
n=39 Participants • Not all patients were evaluated for each abnormality
|
5 Participants
n=42 Participants • Not all patients were evaluated for each abnormality
|
9 Participants
n=81 Participants • Not all patients were evaluated for each abnormality
|
|
Physical examination
Cardiovascular
|
0 Participants
n=39 Participants • Not all patients were evaluated for each abnormality
|
0 Participants
n=42 Participants • Not all patients were evaluated for each abnormality
|
0 Participants
n=81 Participants • Not all patients were evaluated for each abnormality
|
|
Physical examination
Abdomen
|
5 Participants
n=39 Participants • Not all patients were evaluated for each abnormality
|
2 Participants
n=42 Participants • Not all patients were evaluated for each abnormality
|
7 Participants
n=81 Participants • Not all patients were evaluated for each abnormality
|
|
Physical examination
Lymph nodes
|
7 Participants
n=37 Participants • Not all patients were evaluated for each abnormality
|
8 Participants
n=41 Participants • Not all patients were evaluated for each abnormality
|
15 Participants
n=78 Participants • Not all patients were evaluated for each abnormality
|
|
Physical examination
Extremities/back
|
7 Participants
n=39 Participants • Not all patients were evaluated for each abnormality
|
7 Participants
n=41 Participants • Not all patients were evaluated for each abnormality
|
14 Participants
n=80 Participants • Not all patients were evaluated for each abnormality
|
|
Physical examination
Musculoskeletal
|
2 Participants
n=34 Participants • Not all patients were evaluated for each abnormality
|
4 Participants
n=40 Participants • Not all patients were evaluated for each abnormality
|
6 Participants
n=74 Participants • Not all patients were evaluated for each abnormality
|
|
Physical examination
Neurological
|
1 Participants
n=34 Participants • Not all patients were evaluated for each abnormality
|
2 Participants
n=40 Participants • Not all patients were evaluated for each abnormality
|
3 Participants
n=74 Participants • Not all patients were evaluated for each abnormality
|
|
Physical examination
Other body system
|
2 Participants
n=37 Participants • Not all patients were evaluated for each abnormality
|
4 Participants
n=40 Participants • Not all patients were evaluated for each abnormality
|
6 Participants
n=77 Participants • Not all patients were evaluated for each abnormality
|
|
Vital Signs: temperature
|
36.2 degrees C
n=40 Participants • Totals are patients with available data
|
36.5 degrees C
n=40 Participants • Totals are patients with available data
|
36.4 degrees C
n=80 Participants • Totals are patients with available data
|
|
Height
|
1.74 meters
STANDARD_DEVIATION 0.1 • n=41 Participants
|
1.70 meters
STANDARD_DEVIATION 0.1 • n=42 Participants
|
1.72 meters
STANDARD_DEVIATION 0.1 • n=83 Participants
|
|
Weight
|
88.4 kg
STANDARD_DEVIATION 19.0 • n=41 Participants
|
83.0 kg
STANDARD_DEVIATION 19.5 • n=42 Participants
|
85.7 kg
STANDARD_DEVIATION 19.3 • n=83 Participants
|
|
Body Surface Area (BSA)
|
2.022 m^2
STANDARD_DEVIATION 0.232 • n=41 Participants
|
1.939 m^2
STANDARD_DEVIATION 0.260 • n=42 Participants
|
1.980 m^2
STANDARD_DEVIATION 0.249 • n=83 Participants
|
|
Biochemistry
ALT
|
26 U/L
n=41 Participants • Numbers analysed are available data
|
22 U/L
n=41 Participants • Numbers analysed are available data
|
24 U/L
n=82 Participants • Numbers analysed are available data
|
|
Biochemistry
AST
|
24 U/L
n=37 Participants • Numbers analysed are available data
|
22 U/L
n=38 Participants • Numbers analysed are available data
|
23 U/L
n=75 Participants • Numbers analysed are available data
|
|
LDH
Above Upper limit normal
|
20 Participants
n=41 Participants
|
27 Participants
n=42 Participants
|
47 Participants
n=83 Participants
|
|
LDH
Below Upper limit normal
|
21 Participants
n=41 Participants
|
15 Participants
n=42 Participants
|
36 Participants
n=83 Participants
|
|
Haematology
White cell count
|
8 cells x 10^9/L
n=41 Participants • Numbers analysed are those with available data
|
7 cells x 10^9/L
n=41 Participants • Numbers analysed are those with available data
|
8 cells x 10^9/L
n=82 Participants • Numbers analysed are those with available data
|
|
Haematology
Neutrophils
|
5 cells x 10^9/L
n=41 Participants • Numbers analysed are those with available data
|
5 cells x 10^9/L
n=41 Participants • Numbers analysed are those with available data
|
5 cells x 10^9/L
n=82 Participants • Numbers analysed are those with available data
|
|
Haematology
Platelets
|
259 cells x 10^9/L
n=41 Participants • Numbers analysed are those with available data
|
255 cells x 10^9/L
n=41 Participants • Numbers analysed are those with available data
|
259 cells x 10^9/L
n=82 Participants • Numbers analysed are those with available data
|
|
Abnormal ECG
|
4 Participants
n=41 Participants • Number Analyzed represents the number of participants evaluated for this Baseline Measure
|
4 Participants
n=41 Participants • Number Analyzed represents the number of participants evaluated for this Baseline Measure
|
8 Participants
n=82 Participants • Number Analyzed represents the number of participants evaluated for this Baseline Measure
|
|
Abnormal Urinalysis
|
9 Participants
n=39 Participants • Number Analyzed represents the number of participants evaluated for this Baseline Measure
|
8 Participants
n=38 Participants • Number Analyzed represents the number of participants evaluated for this Baseline Measure
|
17 Participants
n=77 Participants • Number Analyzed represents the number of participants evaluated for this Baseline Measure
|
|
Conmeds
|
35 Participants
n=41 Participants
|
33 Participants
n=42 Participants
|
68 Participants
n=83 Participants
|
|
Target lesion Sum LD
|
98 mm
n=41 Participants
|
56 mm
n=42 Participants
|
71 mm
n=83 Participants
|
|
Vital Signs: Pulse rate
|
70 Beats per minutes
n=41 Participants • Totals are patients with available data
|
72 Beats per minutes
n=41 Participants • Totals are patients with available data
|
71.5 Beats per minutes
n=82 Participants • Totals are patients with available data
|
|
Vital Signs: Systolic blood pressure
|
137 mmHg
n=41 Participants • Totals are patients with available data
|
136 mmHg
n=41 Participants • Totals are patients with available data
|
137 mmHg
n=82 Participants • Totals are patients with available data
|
|
Diastolic BP
|
85 mmHg
n=41 Participants • Totals are patients with available data
|
82 mmHg
n=41 Participants • Totals are patients with available data
|
83.5 mmHg
n=82 Participants • Totals are patients with available data
|
|
Biochemistry: Bilirubin
|
10 µmol/L
n=41 Participants • Numbers analysed are available data
|
8 µmol/L
n=41 Participants • Numbers analysed are available data
|
9 µmol/L
n=82 Participants • Numbers analysed are available data
|
|
Biochemistry: Creatine clearance
|
111 ml/min
n=40 Participants • Numbers analysed are available data
|
94 ml/min
n=41 Participants • Numbers analysed are available data
|
98 ml/min
n=81 Participants • Numbers analysed are available data
|
|
Haematology: Haemoglobin
|
14 g/dL
n=41 Participants • Numbers analysed are those with available data
|
14 g/dL
n=41 Participants • Numbers analysed are those with available data
|
14 g/dL
n=82 Participants • Numbers analysed are those with available data
|
PRIMARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.Population: The primary analysis was intention to treat and involved all patients who were randomly assigned.
This is defined as time from date of randomisation to the first of date of progression (using CT scan, x-ray, MRI scan and clinical examination) using modified RECIST (v1.1) criteria or date of death (events). For patients without an event, the time from date of randomisation to date last known alive will be the censored PFS time.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=41 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=42 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Progression Free Survival
|
4.23 months
Interval 3.63 to 6.9
|
3.93 months
Interval 2.07 to 4.16
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.Population: Intention to treat i.e. all randomised patients
PFS at 6 months is defined as the percentage progression free survival at 6 months from the PFS Kaplan Meier graph. This would allow all patients randomised to be included. progression was diagnosed using CT scan, x-ray, MRI scan and clinical examination using modified RECIST(v1.1) criteria.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=41 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=42 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Progression Free Survival Rate at 6 Months
|
40 percentage of participants
Interval 27.0 to 53.0
|
26 percentage of participants
Interval 15.0 to 38.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.This is defined as the time from randomisation to death (event) or time from randomisation to date last known alive (censored time).
Outcome measures
| Measure |
Docetaxel and AZD6244
n=41 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=42 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Overall Survival
|
9.5 months
Interval 8.467 to 12.9
|
11.367 months
Interval 7.467 to 18.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.Population: intention to treat
Objective response rate calculated as number of patients with Complete Response (CR) or Partial response (PR) over all patients randomised. The numerator of the objective response rate is the number of patients achieving a CR or PR. The denominator is all patients randomised. RECIST(v1.1) criteria was used for assessment.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=41 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=42 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Objective Response Rate
Complete response
|
1 Participants
|
0 Participants
|
|
Objective Response Rate
Partial response
|
12 Participants
|
6 Participants
|
|
Objective Response Rate
Stable disease
|
14 Participants
|
15 Participants
|
|
Objective Response Rate
Progressive disease
|
5 Participants
|
19 Participants
|
|
Objective Response Rate
Not applicable
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.Population: Intention to treat
OS analysis was carried out at the final analysis time point on data taken on 01Oct2012. Another data extraction was taken on 05Mar2013 in order to carry out posthoc analyses, OS was analysed again on this data. OS is time from randomisation to death (event) or time from randomisation to date last known alive (censored time).
Outcome measures
| Measure |
Docetaxel and AZD6244
n=41 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=42 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Overall Survival Results - Post Final Analysis
|
9.5 months
Interval 8.47 to 12.53
|
11.37 months
Interval 8.67 to 16.03
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Vital signs - temperature.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=361 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=371 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Vital Signs - Temperature
|
36.2 Degree celsius
Interval 35.9 to 36.6
|
36.3 Degree celsius
Interval 35.9 to 36.7
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Vital signs - pulse rate.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=374 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=377 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Vital Signs - Pulse Rate
|
78 Beats per minute
Interval 69.0 to 88.0
|
84 Beats per minute
Interval 72.0 to 96.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Whole study
Vital signs - systolic blood pressure.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=375 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=379 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Vital Signs - Systolic Blood Pressure
|
131 Mg mercury
Interval 121.0 to 144.0
|
130 Mg mercury
Interval 120.0 to 140.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Vital signs - diastolic blood pressure.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=375 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=378 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Vital Signs - Diastolic Blood Pressure
|
82 Mg mercury
Interval 73.0 to 90.0
|
79 Mg mercury
Interval 71.0 to 85.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Weight.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=320 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=317 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Weight
|
90.425 Kg
Interval 80.95 to 99.1
|
83.45 Kg
Interval 68.2 to 96.7
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Whole study
Haematology - haemoglobin.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=385 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=400 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Haematology - Haemoglobin
|
12.5 grams per litre
Interval 11.6 to 13.6
|
12.9 grams per litre
Interval 11.7 to 13.9
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are median values across all time-points for all patients in that arm.Population: Intention to treat
Haematology - white cell count.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=386 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=400 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Haematology - White Cell Count
|
7.75 10^9 cells litre
Interval 5.1 to 11.2
|
8.405 10^9 cells litre
Interval 4.84 to 13.295
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Haematology - neutrophils.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=385 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=400 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Haematology - Neutrophils
|
5.4 10^9 cells litre
Interval 2.64 to 8.82
|
5.7 10^9 cells litre
Interval 2.85 to 11.46
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Haematology - platelets.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=385 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=400 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Haematology - Platelets
|
267 10^9 cells litre
Interval 223.0 to 324.0
|
290.5 10^9 cells litre
Interval 229.5 to 363.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - phosphate.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=350 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=346 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - Phosphate
|
1.245 mmol per litre
Interval 1.08 to 1.43
|
1 mmol per litre
Interval 0.86 to 1.16
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - calcium.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=373 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=384 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - Calcium
|
2.28 mmol per litre
Interval 2.2 to 2.36
|
2.34 mmol per litre
Interval 2.26 to 2.43
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - sodium.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=383 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=396 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - Sodium
|
139 mmol per litre
Interval 137.0 to 141.0
|
139 mmol per litre
Interval 137.0 to 140.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - potassium.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=379 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=389 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - Potassium
|
4.3 mmol per litre
Interval 4.0 to 4.54
|
4.3 mmol per litre
Interval 4.0 to 4.6
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - urea.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=383 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=393 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - Urea
|
5.7 mmol per litre
Interval 4.7 to 6.6
|
5.2 mmol per litre
Interval 4.1 to 6.4
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - bilirubin.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=380 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=391 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - Bilirubin
|
7 umol per litre
Interval 5.0 to 10.0
|
7 umol per litre
Interval 5.0 to 10.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - alkaline phosphatase.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=383 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=394 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - Alkaline Phosphatase
|
93 IU per litre
Interval 72.0 to 147.0
|
85 IU per litre
Interval 64.0 to 153.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - ALT.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=380 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=390 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - ALT
|
32 IU per litre
Interval 23.0 to 47.0
|
21 IU per litre
Interval 16.0 to 31.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - AST.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=308 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=351 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - AST
|
32 IU per litre
Interval 25.0 to 41.0
|
20 IU per litre
Interval 17.0 to 26.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - albumin.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=383 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=394 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - Albumin
|
37 grams per litre
Interval 34.0 to 41.0
|
40 grams per litre
Interval 37.0 to 43.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - GGT.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=354 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=357 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - GGT
|
41 grams per litre
Interval 26.0 to 73.0
|
30 grams per litre
Interval 20.0 to 52.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - total protein.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=377 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=378 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - Total Protein
|
66 grams per litre
Interval 62.0 to 71.0
|
67 grams per litre
Interval 63.0 to 71.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - LDH.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=339 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=326 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - LDH
|
305 Units per litre
Interval 243.0 to 491.0
|
386.5 Units per litre
Interval 233.0 to 499.0
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported value for each arm is median value across all time-points for all patients in that arm.Population: Intention to treat
Biochemistry - creatinine.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=334 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=346 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Biochemistry - Creatinine
|
113.6 milligrams per decalitre
Interval 94.0 to 139.26
|
98.3 milligrams per decalitre
Interval 83.5 to 119.18
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
Physical assessment - general appearance.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=234 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=198 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Physical Assessment - General Appearance
Normal
|
181 Data points
|
162 Data points
|
|
Physical Assessment - General Appearance
Abnormal
|
35 Data points
|
24 Data points
|
|
Physical Assessment - General Appearance
Not evaluated
|
18 Data points
|
12 Data points
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
Physical exam - skin.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=234 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=197 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Physical Exam - Skin
Normal
|
56 Data points
|
86 Data points
|
|
Physical Exam - Skin
Abnormal
|
155 Data points
|
99 Data points
|
|
Physical Exam - Skin
Not evaluated
|
23 Data points
|
12 Data points
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
Physical exam - head and neck.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=234 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=197 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Physical Exam - Head and Neck
Normal
|
139 Data points
|
146 Data points
|
|
Physical Exam - Head and Neck
Abnormal
|
61 Data points
|
23 Data points
|
|
Physical Exam - Head and Neck
Not evaluated
|
34 Data points
|
28 Data points
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
Physical exam - chest.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=234 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=197 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Physical Exam - Chest
Normal
|
187 Data points
|
170 Data points
|
|
Physical Exam - Chest
Abnormal
|
29 Data points
|
16 Data points
|
|
Physical Exam - Chest
Not evaluated
|
18 Data points
|
11 Data points
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
Physical exam - cardiovascular.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=234 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=197 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Physical Exam - Cardiovascular
Normal
|
204 Data points
|
180 Data points
|
|
Physical Exam - Cardiovascular
Abnormal
|
7 Data points
|
6 Data points
|
|
Physical Exam - Cardiovascular
Not evaluated
|
23 Data points
|
11 Data points
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
Physical exam - abdomen.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=234 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=197 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Physical Exam - Abdomen
Normal
|
205 Data points
|
163 Data points
|
|
Physical Exam - Abdomen
Abnormal
|
5 Data points
|
24 Data points
|
|
Physical Exam - Abdomen
Not evaluated
|
24 Data points
|
10 Data points
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
Physical exam - lymph nodes.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=234 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=197 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Physical Exam - Lymph Nodes
Normal
|
162 Data points
|
148 Data points
|
|
Physical Exam - Lymph Nodes
Abnormal
|
19 Data points
|
27 Data points
|
|
Physical Exam - Lymph Nodes
Not evaluated
|
53 Data points
|
22 Data points
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
Physical exam - extremities.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=234 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=197 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Physical Exam - Extremities
Normal
|
114 Data points
|
139 Data points
|
|
Physical Exam - Extremities
Abnormal
|
83 Data points
|
37 Data points
|
|
Physical Exam - Extremities
Not evaluated
|
37 Data points
|
21 Data points
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
Physical exam - musculoskeletal.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=234 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=197 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Physical Exam - Musculoskeletal
Normal
|
156 Data points
|
149 Data points
|
|
Physical Exam - Musculoskeletal
Abnormal
|
19 Data points
|
13 Data points
|
|
Physical Exam - Musculoskeletal
Not evaluated
|
59 Data points
|
35 Data points
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
Physical exam - neurological.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=234 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=197 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Physical Exam - Neurological
Normal
|
149 Data points
|
129 Data points
|
|
Physical Exam - Neurological
Abnormal
|
7 Data points
|
19 Data points
|
|
Physical Exam - Neurological
Not evaluated
|
78 Data points
|
49 Data points
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
Physical exam - other.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=52 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=47 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Physical Exam - Other
Normal
|
4 Data points
|
4 Data points
|
|
Physical Exam - Other
Abnormal
|
40 Data points
|
31 Data points
|
|
Physical Exam - Other
Not evaluated
|
8 Data points
|
12 Data points
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
ECG - pre-dose.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=67 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=122 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
ECG - Pre-dose
Normal
|
39 Data points
|
39 Data points
|
|
ECG - Pre-dose
Abnormal
|
5 Data points
|
6 Data points
|
|
ECG - Pre-dose
Not evalauated
|
23 Data points
|
77 Data points
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
ECG - post-dose.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=68 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=127 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
ECG - Post-dose
Normal
|
32 Data points
|
34 Data points
|
|
ECG - Post-dose
Abnormal
|
5 Data points
|
6 Data points
|
|
ECG - Post-dose
Not evaluated
|
31 Data points
|
87 Data points
|
SECONDARY outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months. Reported values for each arm are total counts across all time-points for all patients in that arm.Population: Intention to treat
Urinalysis.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=372 Data points
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=365 Data points
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Urinalysis
Normal
|
205 Data points
|
229 Data points
|
|
Urinalysis
Abnormal
|
130 Data points
|
117 Data points
|
|
Urinalysis
Not evaluated
|
37 Data points
|
19 Data points
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.Population: This is a sensitivity analysis of the primary outcome and includes randomised patients that had CT scans as per protocol.
Same as for primary analysis. This is defined as time from date of randomisation to the first of date of progression (using CT scan, x-ray, MRI scan and clinical examination) using modified RECIST v1.1 criteria or date of death (events). For patients without an event, the time from date of randomisation to date last known alive will be the censored PFS time.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=28 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=33 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Progression Free Survival: Sensitivity Analysis 1
|
4.1 months
Interval 2.1 to 4.233
|
3.333 months
Interval 2.067 to 4.167
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.Population: Per-protocol population, this is the primary analysis population excluding four patients who did not start treatment and two patients who were later found to be ineligible.
Same as for primary analysis. This is defined as time from date of randomisation to the first of date of progression (using CT scan, x-ray, MRI scan and clinical examination) using modified RECIST v1.1. criteria or date of death (events). For patients without an event, the time from date of randomisation to date last known alive will be the censored PFS time.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=37 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=40 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Progression Free Survival- Per Protocol Analysis
|
4.3 months
Interval 4.1 to 7.033
|
4.067 months
Interval 2.1 to 4.2
|
POST_HOC outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.Population: per protocol population and only those with NRAS status
Outcome is time from randomisation to progression or death in subset of patients with NRAS mutational data available and in the per-protocol population. progression was diagnosed using CT scan, x-ray, MRI scan and clinical examination using modified RECIST(v1.1) criteria. NRAS mutational analysis (wild type or mutated) for all patients was derived from archival melanoma tumour tissue samples.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=29 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=31 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Progression Free Survival: in Patients With NRAS Data
|
4.4 months
Interval 3.4 to 7.13
|
4.1 months
Interval 2.07 to 4.2
|
POST_HOC outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.Population: Per protocol population and only those with NRAS data
Outcome is time from randomisation to death in subset of patients with NRAS mutational data available and in the per-protocol population. NRAS mutational analysis (wild type or mutated) for all patients was derived from archival melanoma tumour tissue samples.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=29 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=31 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Overall Survival in Patients With NRAS Data
|
12.07 months
Interval 8.47 to 12.9
|
11.9 months
Interval 9.3 to 18.0
|
POST_HOC outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.Population: Per protocol population and only those with NRAS status- wild type
Best overall response as reported for evaluable/measurable scans including target, non-target and new lesions. Response assessed using RECIST(v1.1) criteria. Data from Mar2013 which was post final data lock
Outcome measures
| Measure |
Docetaxel and AZD6244
n=9 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=14 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Objective Response Rate in Patients With WT NRAS
Stable disease
|
4 Participants
|
4 Participants
|
|
Objective Response Rate in Patients With WT NRAS
Complete response
|
0 Participants
|
0 Participants
|
|
Objective Response Rate in Patients With WT NRAS
Partial response
|
2 Participants
|
2 Participants
|
|
Objective Response Rate in Patients With WT NRAS
Progressive disease
|
3 Participants
|
8 Participants
|
|
Objective Response Rate in Patients With WT NRAS
Not applicable
|
0 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.Population: Per protocol population.
OS analysis was carried out at the final analysis time point on data taken on 01Oct2012. Another data extraction was taken on 05Mar2013 in order to carry out posthoc analyses, OS was analysed again on this data. OS is time from randomisation to death (event) or time from randomisation to date last known alive (censored time).
Outcome measures
| Measure |
Docetaxel and AZD6244
n=37 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=40 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Overall Survival Results - Post Final Analysis- Per-protocol
|
10.9 months
Interval 8.53 to 12.53
|
11.77 months
Interval 8.67 to 16.03
|
POST_HOC outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.Population: per-protocol population and only patients with NRAS mutational data and excluding patients found to have BRAF mutation on retesting
Outcome is time from randomisation to progression or death in subset of patients with NRAS mutational data available and in the per-protocol population and excluding patients found to have BRAF mutation on retesting (the inclusion criteria for the trial is those with wildtype BRAF). progression was diagnosed using CT scan, x-ray, MRI scan and clinical examination using modified RECIST(v1.1) criteria. NRAS mutational analysis (wild type or mutated) for all patients was derived from archival melanoma tumour tissue samples.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=28 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=30 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Progression Free Survival: in Patients With NRAS Data- Sensitivity
|
4.4 months
Interval 3.4 to 7.27
|
4.1 months
Interval 2.07 to 4.27
|
POST_HOC outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.Population: Per-protocol population, including only patients with NRAS data and excluding patients found to have BRAF mutation on retesting
Outcome is time from randomisation to death in subset of patients with NRAS mutational data available and in the per-protocol population and excluding patients found to have BRAF mutation on retesting (the inclusion criteria for the trial is those with wildtype BRAF). NRAS mutational analysis (wild type or mutated) for all patients was derived from archival melanoma tumour tissue samples.
Outcome measures
| Measure |
Docetaxel and AZD6244
n=28 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=30 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Overall Survival in Patients With NRAS Data- Sensitivity
|
12.07 months
Interval 8.47 to 12.9
|
11.9 months
Interval 10.43 to 18.0
|
POST_HOC outcome
Timeframe: From randomisation date to date of PFS event, if they did not have an event by the end of trial datalock (01Oct2012), an average of 9.3 months.Population: Per protocol population and only those with NRAS status=mutated
Best overall response as reported for evaluable/measurable scans including target, non-target and new lesions. Response assessed using RECIST(v1.1) criteria. Data from Mar2013 which was post final data lock
Outcome measures
| Measure |
Docetaxel and AZD6244
n=20 Participants
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=17 Participants
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Objective Response Rate in Patients With Mutated NRAS
Complete response
|
1 Participants
|
0 Participants
|
|
Objective Response Rate in Patients With Mutated NRAS
Partial response
|
6 Participants
|
2 Participants
|
|
Objective Response Rate in Patients With Mutated NRAS
Stable disease
|
7 Participants
|
9 Participants
|
|
Objective Response Rate in Patients With Mutated NRAS
Progressive disease
|
2 Participants
|
6 Participants
|
|
Objective Response Rate in Patients With Mutated NRAS
Not applicable
|
4 Participants
|
0 Participants
|
Adverse Events
Docetaxel and AZD6244
Serious events: 29 serious events
Other events: 35 other events
Deaths: 26 deaths
Docetaxel and Placebo
Serious events: 20 serious events
Other events: 40 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Docetaxel and AZD6244
n=41 participants at risk
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=42 participants at risk
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
48.8%
20/41 • Number of events 25 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
31.0%
13/42 • Number of events 16 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Cardiac disorders
Cardiac Arrest
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Eye disorders
Retinal Vascular Disorder
|
100.0%
1/1 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
—
0/0 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
100.0%
2/2 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
100.0%
1/1 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
2/2 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
General disorders
Fever
|
12.2%
5/41 • Number of events 6 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
4.8%
2/42 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Immune system disorders
Allergic Reaction
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Other - Source Unknown
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Enterocolitis Infectious
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Skin Infection
|
4.9%
2/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Lung Infection
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
4.8%
2/42 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Upper Respiratory Infection
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Sepsis
|
4.9%
2/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Investigations
Neutrophil Count Decreased
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
Other adverse events
| Measure |
Docetaxel and AZD6244
n=41 participants at risk
Docetaxel with AZD6244
Docetaxel and AZD6244: Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
|
Docetaxel and Placebo
n=42 participants at risk
Docetaxel without AZD6244
Docetaxel and placebo: Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
7.3%
3/41 • Number of events 3 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Diverticular Perforation
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Dysphagia
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
4.8%
2/42 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Renal and urinary disorders
Dysuria
|
4.9%
2/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
General disorders
Extravasation
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Investigations
Gamma-Glutamyltransferase
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Blood and lymphatic system disorders
Anaemia
|
4.9%
2/41 • Number of events 6 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
9.5%
4/42 • Number of events 5 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
19.5%
8/41 • Number of events 11 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
11.9%
5/42 • Number of events 6 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Eye disorders
Blurred Vision
|
9.8%
4/41 • Number of events 5 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Eye disorders
Dry Eye
|
4.9%
2/41 • Number of events 3 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Eye disorders
Floaters
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Eye disorders
Watering Eyes
|
12.2%
5/41 • Number of events 7 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
11.9%
5/42 • Number of events 5 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Nausea
|
46.3%
19/41 • Number of events 30 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
35.7%
15/42 • Number of events 18 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Constipation
|
26.8%
11/41 • Number of events 13 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
26.2%
11/42 • Number of events 15 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
1/41 • Number of events 3 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Dyspepsia
|
12.2%
5/41 • Number of events 8 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
23.8%
10/42 • Number of events 13 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
78.0%
32/41 • Number of events 81 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
47.6%
20/42 • Number of events 29 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Dry Mouth
|
14.6%
6/41 • Number of events 9 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
7.1%
3/42 • Number of events 3 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Vomiting
|
26.8%
11/41 • Number of events 15 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
19.0%
8/42 • Number of events 9 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.9%
2/41 • Number of events 3 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
4.8%
2/42 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Mucositis Oral
|
48.8%
20/41 • Number of events 35 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
40.5%
17/42 • Number of events 27 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
General disorders
Localized Edema
|
36.6%
15/41 • Number of events 22 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
19.0%
8/42 • Number of events 12 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
General disorders
Fatigue
|
68.3%
28/41 • Number of events 58 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
76.2%
32/42 • Number of events 60 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
General disorders
Fever
|
17.1%
7/41 • Number of events 9 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
7.1%
3/42 • Number of events 3 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Immune system disorders
Allergic Reaction
|
9.8%
4/41 • Number of events 5 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
11.9%
5/42 • Number of events 7 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Nail Infection
|
4.9%
2/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Upper Respiratory Infection
|
9.8%
4/41 • Number of events 4 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Mucosal Infection
|
4.9%
2/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
11.9%
5/42 • Number of events 6 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Bronchial Infection
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
9.5%
4/42 • Number of events 4 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Wound Infection
|
4.9%
2/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Urinary Tract Infection
|
4.9%
2/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Other Infection
|
7.3%
3/41 • Number of events 6 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Skin Infection
|
12.2%
5/41 • Number of events 7 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
7.1%
3/42 • Number of events 4 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Investigations
Neutrophil Count Decreased
|
9.8%
4/41 • Number of events 6 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
31.0%
13/42 • Number of events 15 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 3 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Metabolism and nutrition disorders
Anorexia
|
22.0%
9/41 • Number of events 12 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
19.0%
8/42 • Number of events 11 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
4/41 • Number of events 7 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
23.8%
10/42 • Number of events 13 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.2%
5/41 • Number of events 7 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
19.0%
8/42 • Number of events 11 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Musculoskeletal and connective tissue disorders
Pain - Other
|
41.5%
17/41 • Number of events 43 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
26.2%
11/42 • Number of events 18 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
22.0%
9/41 • Number of events 11 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
31.0%
13/42 • Number of events 16 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Nervous system disorders
Dizziness
|
12.2%
5/41 • Number of events 11 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
9.5%
4/42 • Number of events 4 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Nervous system disorders
Dysgeusia
|
34.1%
14/41 • Number of events 19 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
31.0%
13/42 • Number of events 18 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Nervous system disorders
Headache
|
7.3%
3/41 • Number of events 3 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
7.1%
3/42 • Number of events 4 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Psychiatric disorders
Depression
|
14.6%
6/41 • Number of events 8 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
9.5%
4/42 • Number of events 6 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.3%
3/41 • Number of events 3 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
14.3%
6/42 • Number of events 6 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
22.0%
9/41 • Number of events 13 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
9.5%
4/42 • Number of events 7 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
2/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
7.1%
3/42 • Number of events 5 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Other Rash
|
4.9%
2/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
17.1%
7/41 • Number of events 8 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
21.4%
9/42 • Number of events 12 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
70.7%
29/41 • Number of events 54 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
47.6%
20/42 • Number of events 26 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
14.6%
6/41 • Number of events 8 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
46.3%
19/41 • Number of events 20 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
47.6%
20/42 • Number of events 21 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
12.2%
5/41 • Number of events 6 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Periorbital Edema
|
14.6%
6/41 • Number of events 7 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Vascular disorders
Flushing
|
7.3%
3/41 • Number of events 3 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
14.3%
6/42 • Number of events 7 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Vascular disorders
Thromboembolic Event
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Metabolism and nutrition disorders
Blood Potassium
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
General disorders
Chest Discomfort
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
General disorders
Chills
|
7.3%
3/41 • Number of events 3 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Psychiatric disorders
Confusional State
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
4.8%
2/42 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Eye disorders
Conjunctivitis
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Nervous system disorders
Convulsion
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Cystitis
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Gastrooeophageal Reflux Disease
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
4.8%
2/42 • Number of events 3 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
4.8%
2/42 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Vascular disorders
Hypertension
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
4.8%
2/42 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Vascular disorders
Hypotension
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Influenza Like Illness
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Nervous system disorders
Memory Impairment
|
2.4%
1/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Renal and urinary disorders
Nocturia
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Reproductive system and breast disorders
Postmenopausal Haemorrhage
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.9%
2/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
7.3%
3/41 • Number of events 3 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Rhinitis
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Scab
|
4.9%
2/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic Keratosis
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
2.4%
1/41 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Skin and subcutaneous tissue disorders
Skin Nodule
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Nervous system disorders
Syncope
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Tongue Coated
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Tooth Discolouration
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Gastrointestinal disorders
Tooth Loss
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Nervous system disorders
Tremor
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
2.4%
1/41 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
0.00%
0/42 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
2.4%
1/42 • Number of events 1 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
|
Investigations
Weight Decreased
|
0.00%
0/41 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
4.8%
2/42 • Number of events 2 • 170 days
Adverse event monitoring starts from the time the patient receives any of the research procedures until 30 days post treatment (treatment was 6 3-week cycles, 126 days) and the first trial research procedure was up to 14 days prior to starting treatment. Total safety assessment time frame was a maximum of 170 days and minimum of 157 days, dependent on when the patient had their first research procedure prior to starting treatment (1-14 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place