Trial Outcomes & Findings for Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma (NCT NCT01108445)
NCT ID: NCT01108445
Last Updated: 2018-01-16
Results Overview
The primary objective will be to compare the anti-tumor activity of everolimus and sunitinib in subjects with mRCC with non-clear cell pathology, as measured by progression-free survival (PFS) following treatment initiation according to RECIST 1.1 criteria. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
24 Months
Results posted on
2018-01-16
Participant Flow
131 participants signed consent. 22 were screen failures. 1 withdrew consent prior to being randomized. 108 participant were randomized.
Participant milestones
| Measure |
RAD001
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
51
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
56
|
49
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
RAD001
n=57 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 11.85 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 13.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 MonthsThe primary objective will be to compare the anti-tumor activity of everolimus and sunitinib in subjects with mRCC with non-clear cell pathology, as measured by progression-free survival (PFS) following treatment initiation according to RECIST 1.1 criteria. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
RAD001
n=57 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Anti-tumor Activity as Measured by Median Progression Free Survival Time
|
5.6 Months
Interval 5.5 to 6.0
|
8.3 Months
Interval 5.8 to 11.4
|
SECONDARY outcome
Timeframe: 6, 12 and 24 months6-, 12-, and 24-month rates of PFS in each arm will be compared for each treatment arm. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
RAD001
n=57 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Progression Free Survival Rates
6 Months
|
40.3 percentage of participants
Interval 27.3 to 52.8
|
55.0 percentage of participants
Interval 40.1 to 67.7
|
|
Progression Free Survival Rates
12 Months
|
17.0 percentage of participants
Interval 8.4 to 28.3
|
37.7 percentage of participants
Interval 24.1 to 51.2
|
|
Progression Free Survival Rates
24 Months
|
9.3 percentage of participants
Interval 3.0 to 20.2
|
22.8 percentage of participants
Interval 11.7 to 36.1
|
SECONDARY outcome
Timeframe: 24 monthsProgression-free survival (PFS) expressed in months as compared to an historic control (interferon-treated clear cell RCC control arm from the sunitinib phase III study). Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
RAD001
n=57 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
PFS Expressed in Months
|
5.6 Months
Interval 4.4 to 6.1
|
8.3 Months
Interval 5.6 to 13.0
|
SECONDARY outcome
Timeframe: 24 monthsDefined as complete response \[CR\] and partial response \[PR\] by RECIST 1.1 criteria in each treatment arm.Overall Response Rate (ORR) = CR + PR. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
RAD001
n=57 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Overall Response Rate
|
8.8 percentage of participants
Interval 1.4 to 16.1
|
17.6 percentage of participants
Interval 7.2 to 28.1
|
SECONDARY outcome
Timeframe: Baseline to 36 monthsPercentage of participants with stable disease during treatment is defined as stable disease \[SD\] by RECIST 1.1 criteria as calculated in each treatment arm. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
RAD001
n=57 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Percentage of Participants With Stable Disease (SD)
|
59.6 percentage of participants
Interval 46.9 to 72.4
|
64.7 percentage of participants
Interval 51.6 to 77.8
|
SECONDARY outcome
Timeframe: Baseline to 36 monthsRate of complete or partial response or stable disease by the RECIST 1.1 criteria lasting ≥ 12 weeks prior to progression. Benefit rate is defined as complete response \[CR\] and partial response \[PR\] and stable disease \[SD\] by RECIST 1.1 criteria in each treatment arm. Benefit rate = CR + PR + SD. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
RAD001
n=57 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
12 Week Clinical Benefit Rate as Percentage
|
24.6 percentage of particpants
Interval 13.4 to 35.7
|
41.2 percentage of particpants
Interval 27.7 to 54.7
|
SECONDARY outcome
Timeframe: 6, 12, 24, 36 monthsTo compare overall survival (OS) rates at 6, 12, 24, and 36 months and over time in each treatment arm.
Outcome measures
| Measure |
RAD001
n=57 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Overall Survival Rates
6 months
|
83.5 percentage probability
Interval 70.7 to 91.1
|
85.4 percentage probability
Interval 71.8 to 92.8
|
|
Overall Survival Rates
12 months
|
57.7 percentage probability
Interval 43.0 to 69.8
|
74.7 percentage probability
Interval 59.7 to 84.8
|
|
Overall Survival Rates
24 months
|
40.8 percentage probability
Interval 26.4 to 54.6
|
51.3 percentage probability
Interval 35.1 to 65.3
|
|
Overall Survival Rates
36 months
|
35.7 percentage probability
Interval 20.6 to 51.0
|
46.2 percentage probability
Interval 29.0 to 61.7
|
SECONDARY outcome
Timeframe: 24 monthsTo compare the best tumor shrinkage as a percentile in each treatment arm. The percentile change at each follow up visit is calculated by measuring the percentage change in the Sum of lesion measurement from baseline. The best tumor shrinkage is lowest percentile change. A decrease is indicated by a negative percentage.
Outcome measures
| Measure |
RAD001
n=57 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Best Tumor Shrinkage as a Percentile in Each Arm
|
-2.1 percentile decrease
Interval -14.5 to 5.8
|
-10.7 percentile decrease
Interval -24.1 to 7.1
|
SECONDARY outcome
Timeframe: 24 monthsTo compare the median duration of response (CR, PR, and SD) in each treatment arm. According to RECIST 1.1, Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
RAD001
n=57 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Median Duration of Response (CR, PR, and SD)
|
3.9 months
Interval 2.8 to 9.1
|
8.3 months
Interval 3.1 to 17.2
|
SECONDARY outcome
Timeframe: Up to 40 monthsTo compare the median OS in each treatment arm.
Outcome measures
| Measure |
RAD001
n=57 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Median OS
|
13.2 months
Interval 9.7 to 37.9
|
31.5 months
Interval 14.8 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
SECONDARY outcome
Timeframe: 36 monthsTo compare the time-to-new metastatic disease in each treatment arm, defined from the date of first study agent administration to the onset of a new evaluable site of disease, excluding the primary site and all sites documented at baseline
Outcome measures
| Measure |
RAD001
n=57 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Time-to-new Metastatic Disease in Each Treatment Arm
|
19.4 months
Interval 8.2 to 36.0
|
36 months
Interval 11.4 to 36.0
|
SECONDARY outcome
Timeframe: 24 monthsTo assess toxicities associated with everolimus or sunitinib using NCI CTC version 4.0 criteria
Outcome measures
| Measure |
RAD001
n=57 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
63.2 percentage of participants
Interval 50.6 to 75.7
|
80.4 percentage of participants
Interval 69.5 to 91.3
|
SECONDARY outcome
Timeframe: baseline, cycle 3 day 1Population: All participants who completed the cycle 3 day 1 visit.
To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and cycle 3 day 1 per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.
Outcome measures
| Measure |
RAD001
n=30 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=31 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Change in Quality-of-life
|
-3.5 units on a scale
Standard Deviation 9.61
|
-0.9 units on a scale
Standard Deviation 7.19
|
SECONDARY outcome
Timeframe: baseline, cycle 6 day 1Population: All participants who completed the cycle 6 day 1 visit.
To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and cycle 6 day1 per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.
Outcome measures
| Measure |
RAD001
n=13 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=17 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Change in Quality-of-life
|
-4.4 units on a scale
Standard Deviation 6.37
|
-2.1 units on a scale
Standard Deviation 6.69
|
SECONDARY outcome
Timeframe: baseline, up to 40 monthsPopulation: All participants who completed the End of treatment visit.
To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and end of treatment per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.
Outcome measures
| Measure |
RAD001
n=32 Participants
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=30 Participants
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Change in Quality-of-life
|
-6.6 units on a scale
Standard Deviation 7.83
|
-6.4 units on a scale
Standard Deviation 10.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 monthsTo correlate clinical measures of response and PFS with baseline and time-dependent levels of biomarkers. These biomarkers include plasma angiokine levels, tissue immunohistochemical and genomic profiles, copy number as assessed by array-based comparative genomic hybridization (CGH), and known mutations in non-clear cell RCC
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 monthsTo evaluate in an exploratory fashion changes in copy number, RNA expression, and immunohistochemical profiles by microarray between primary non-clear cell RCC tumors and metastatic samples
Outcome measures
Outcome data not reported
Adverse Events
RAD001
Serious events: 36 serious events
Other events: 57 other events
Deaths: 0 deaths
Sunitinib
Serious events: 41 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RAD001
n=57 participants at risk
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 participants at risk
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.5%
2/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Ascites
|
3.5%
2/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
2/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.5%
2/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
General disorders
Disease progression
|
3.5%
2/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
General disorders
Mucosal inflammation
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
General disorders
Multi-organ failure
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
General disorders
Pain
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
General disorders
Pyrexia
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Clostridium difficile colitis
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Infections and infestations
Gastroenteritis
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Infections and infestations
Lung infection
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Infections and infestations
Pneumonia
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Anal abscess
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Haemoglobin decreased
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.5%
2/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Nervous system disorders
Haemorrhagic stroke
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Nervous system disorders
Spinal cord compression
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Psychiatric disorders
Confusional state
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Nephropathy toxic
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Renal failure acute
|
3.5%
2/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Renal impairment
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
3/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.8%
5/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Vascular disorders
Embolism venous
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
Other adverse events
| Measure |
RAD001
n=57 participants at risk
Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
|
Sunitinib
n=51 participants at risk
Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.1%
16/57 • Baseline to 40 months
|
27.5%
14/51 • Baseline to 40 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.5%
2/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
1/57 • Baseline to 40 months
|
9.8%
5/51 • Baseline to 40 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.3%
7/57 • Baseline to 40 months
|
23.5%
12/51 • Baseline to 40 months
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Cardiac disorders
Palpitations
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Cardiac disorders
Tachycardia
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Ear and labyrinth disorders
Ear disorder
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Ear and labyrinth disorders
Ear pain
|
3.5%
2/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Ear and labyrinth disorders
Ear pruritus
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Ear and labyrinth disorders
Otorrhoea
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Eye disorders
Cataract
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Eye disorders
Conjunctivitis
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Eye disorders
Dry eye
|
3.5%
2/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Eye disorders
Eye discharge
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Eye disorders
Eye irritation
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Eye disorders
Eye pain
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Eye disorders
Periorbital oedema
|
3.5%
2/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Eye disorders
Vision blurred
|
3.5%
2/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Eye disorders
Conjunctival pallor
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Eye disorders
Eye swelling
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Eye disorders
Glaucoma
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Eye disorders
Photopsia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Abdominal distension
|
3.5%
2/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Abdominal pain
|
12.3%
7/57 • Baseline to 40 months
|
13.7%
7/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.8%
1/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
3/57 • Baseline to 40 months
|
9.8%
5/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Ascites
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Cheilitis
|
7.0%
4/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Constipation
|
17.5%
10/57 • Baseline to 40 months
|
29.4%
15/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Diarrhoea
|
26.3%
15/57 • Baseline to 40 months
|
66.7%
34/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Dry mouth
|
7.0%
4/57 • Baseline to 40 months
|
9.8%
5/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Dyspepsia
|
8.8%
5/57 • Baseline to 40 months
|
21.6%
11/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Dysphagia
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Faeces discoloured
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
1/57 • Baseline to 40 months
|
11.8%
6/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.8%
1/57 • Baseline to 40 months
|
15.7%
8/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Gingival pain
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Lip swelling
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
8.8%
5/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Nausea
|
45.6%
26/57 • Baseline to 40 months
|
70.6%
36/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Oral pain
|
3.5%
2/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Stomatitis
|
47.4%
27/57 • Baseline to 40 months
|
27.5%
14/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Tongue blistering
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Vomiting
|
22.8%
13/57 • Baseline to 40 months
|
33.3%
17/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
General disorders
Asthenia
|
1.8%
1/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
General disorders
Chest pain
|
3.5%
2/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
General disorders
Chills
|
7.0%
4/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
General disorders
Fatigue
|
57.9%
33/57 • Baseline to 40 months
|
60.8%
31/51 • Baseline to 40 months
|
|
General disorders
Hernia
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
General disorders
Influenza like illness
|
5.3%
3/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
General disorders
Irritability
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
General disorders
Local swelling
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
General disorders
Mucosal inflammation
|
22.8%
13/57 • Baseline to 40 months
|
23.5%
12/51 • Baseline to 40 months
|
|
General disorders
Non-cardiac chest pain
|
5.3%
3/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
General disorders
Oedema
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
General disorders
Oedema peripheral
|
26.3%
15/57 • Baseline to 40 months
|
15.7%
8/51 • Baseline to 40 months
|
|
General disorders
Pain
|
7.0%
4/57 • Baseline to 40 months
|
9.8%
5/51 • Baseline to 40 months
|
|
General disorders
Pyrexia
|
14.0%
8/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
General disorders
Chest discomfort
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
General disorders
Early satiety
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
General disorders
Impaired healing
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Blister infected
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Infections and infestations
Cellulitis
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Cystitis
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Infections and infestations
Ear infection
|
7.0%
4/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Folliculitis
|
1.8%
1/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Infections and infestations
Furuncle
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Hepatitis B
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Infections and infestations
Infection
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Infections and infestations
Influenza
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Localised infection
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Infections and infestations
Lower respiratory tract infection
|
3.5%
2/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Lung infection
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Infections and infestations
Lymph gland infection
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
3/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Infections and infestations
Paronychia
|
3.5%
2/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Pneumonia
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Rash pustular
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Respiratory tract infection
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Rhinitis
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Infections and infestations
Sinusitis
|
3.5%
2/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Soft tissue infection
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Infections and infestations
Urinary tract infection
|
3.5%
2/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
Infections and infestations
Candidiasis
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Infections and infestations
Viral infection
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Injury, poisoning and procedural complications
Contusion
|
1.8%
1/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.5%
2/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Injury, poisoning and procedural complications
Heart injury
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Alanine aminotransferase increased
|
3.5%
2/57 • Baseline to 40 months
|
9.8%
5/51 • Baseline to 40 months
|
|
Investigations
Aspartate aminotransferase increased
|
12.3%
7/57 • Baseline to 40 months
|
19.6%
10/51 • Baseline to 40 months
|
|
Investigations
Blood alkaline phosphatase increased
|
5.3%
3/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Investigations
Blood cholesterol increased
|
12.3%
7/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Blood creatine increased
|
3.5%
2/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Investigations
Blood creatinine increased
|
10.5%
6/57 • Baseline to 40 months
|
17.6%
9/51 • Baseline to 40 months
|
|
Investigations
Blood glucose increased
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Investigations
Blood magnesium decreased
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Investigations
Blood phosphorus decreased
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Investigations
Blood potassium decreased
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Blood triglycerides increased
|
5.3%
3/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Investigations
Blood urea increased
|
1.8%
1/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Investigations
Chest X-ray abnormal
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Investigations
Glomerular filtration rate decreased
|
1.8%
1/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
Investigations
Haemoglobin decreased
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Liver function test abnormal
|
3.5%
2/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Investigations
Low density lipoprotein increased
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Investigations
Platelet count decreased
|
5.3%
3/57 • Baseline to 40 months
|
15.7%
8/51 • Baseline to 40 months
|
|
Investigations
Weight decreased
|
17.5%
10/57 • Baseline to 40 months
|
13.7%
7/51 • Baseline to 40 months
|
|
Investigations
Weight increased
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Investigations
Bacterial test positive
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Blood albumin decreased
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Investigations
Blood calcium decreased
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Blood ketone body increased
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Blood pressure increased
|
0.00%
0/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Clostridium test positive
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Haptoglobin decreased
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Lipase increased
|
0.00%
0/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Mean cell haemoglobin increased
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/57 • Baseline to 40 months
|
15.7%
8/51 • Baseline to 40 months
|
|
Investigations
Protein total decreased
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Protein total increased
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Transaminases increased
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
Urine output decreased
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Investigations
White blood cell count decreased
|
0.00%
0/57 • Baseline to 40 months
|
15.7%
8/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.3%
15/57 • Baseline to 40 months
|
58.8%
30/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.5%
2/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Gout
|
3.5%
2/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.3%
7/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.3%
3/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
1.8%
1/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
14.0%
8/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.5%
2/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.8%
1/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.5%
2/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.8%
5/57 • Baseline to 40 months
|
13.7%
7/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.3%
3/57 • Baseline to 40 months
|
9.8%
5/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/57 • Baseline to 40 months
|
9.8%
5/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.3%
7/57 • Baseline to 40 months
|
23.5%
12/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
6/57 • Baseline to 40 months
|
29.4%
15/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.3%
3/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.8%
5/57 • Baseline to 40 months
|
13.7%
7/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.8%
1/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Muscle mass
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.5%
2/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.5%
6/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.0%
4/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.5%
2/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.8%
1/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.8%
5/57 • Baseline to 40 months
|
13.7%
7/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Nervous system disorders
Ageusia
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Nervous system disorders
Dizziness
|
5.3%
3/57 • Baseline to 40 months
|
11.8%
6/51 • Baseline to 40 months
|
|
Nervous system disorders
Dysgeusia
|
31.6%
18/57 • Baseline to 40 months
|
49.0%
25/51 • Baseline to 40 months
|
|
Nervous system disorders
Headache
|
10.5%
6/57 • Baseline to 40 months
|
9.8%
5/51 • Baseline to 40 months
|
|
Nervous system disorders
Lethargy
|
15.8%
9/57 • Baseline to 40 months
|
19.6%
10/51 • Baseline to 40 months
|
|
Nervous system disorders
Loss of consciousness
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Nervous system disorders
Migraine
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Nervous system disorders
Neuropathy peripheral
|
5.3%
3/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Nervous system disorders
Paraesthesia
|
3.5%
2/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Nervous system disorders
Asterixis
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Nervous system disorders
Encephalomalacia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Nervous system disorders
Parosmia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Psychiatric disorders
Depressed mood
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Psychiatric disorders
Depression
|
3.5%
2/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Psychiatric disorders
Insomnia
|
10.5%
6/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Psychiatric disorders
Mental status changes
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Psychiatric disorders
Mood altered
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Psychiatric disorders
Sleep disorder
|
3.5%
2/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/57 • Baseline to 40 months
|
15.7%
8/51 • Baseline to 40 months
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Bladder hypertrophy
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Bladder spasm
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Dysuria
|
3.5%
2/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Haematuria
|
5.3%
3/57 • Baseline to 40 months
|
9.8%
5/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Micturition urgency
|
3.5%
2/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Nocturia
|
3.5%
2/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Pollakiuria
|
10.5%
6/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Proteinuria
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Renal failure acute
|
1.8%
1/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Urinary tract pain
|
3.5%
2/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Reproductive system and breast disorders
Oedema genital
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Reproductive system and breast disorders
Perineal pain
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Reproductive system and breast disorders
Scrotal swelling
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
43.9%
25/57 • Baseline to 40 months
|
15.7%
8/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
36.8%
21/57 • Baseline to 40 months
|
17.6%
9/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.0%
4/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.3%
11/57 • Baseline to 40 months
|
13.7%
7/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.8%
1/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.8%
1/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.8%
5/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.8%
5/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.3%
3/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.5%
2/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.5%
2/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.8%
1/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
19.3%
11/57 • Baseline to 40 months
|
13.7%
7/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
3/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
1.8%
1/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
14.0%
8/57 • Baseline to 40 months
|
41.2%
21/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.8%
9/57 • Baseline to 40 months
|
13.7%
7/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
31.6%
18/57 • Baseline to 40 months
|
21.6%
11/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.5%
6/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
1.8%
1/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Plantar erythema
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/57 • Baseline to 40 months
|
3.9%
2/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
0.00%
0/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
1/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Vascular disorders
Flushing
|
5.3%
3/57 • Baseline to 40 months
|
2.0%
1/51 • Baseline to 40 months
|
|
Vascular disorders
Hot flush
|
3.5%
2/57 • Baseline to 40 months
|
5.9%
3/51 • Baseline to 40 months
|
|
Vascular disorders
Hypertension
|
10.5%
6/57 • Baseline to 40 months
|
45.1%
23/51 • Baseline to 40 months
|
|
Vascular disorders
Hypotension
|
1.8%
1/57 • Baseline to 40 months
|
7.8%
4/51 • Baseline to 40 months
|
|
Vascular disorders
Thrombophlebitis superficial
|
1.8%
1/57 • Baseline to 40 months
|
0.00%
0/51 • Baseline to 40 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60