Trial Outcomes & Findings for Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer (NCT NCT00719264)
NCT ID: NCT00719264
Last Updated: 2017-03-20
Results Overview
Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
365 participants
Primary outcome timeframe
Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.
Results posted on
2017-03-20
Participant Flow
Participant milestones
| Measure |
Bevacizumab, RAD001 (Everolimus)
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
|
Bevacizumab, Interferon Alfa-2a (IFN)
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
182
|
183
|
|
Overall Study
Full Analysis Set
|
182
|
183
|
|
Overall Study
Safety Set
|
180
|
181
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
182
|
183
|
Reasons for withdrawal
| Measure |
Bevacizumab, RAD001 (Everolimus)
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
|
Bevacizumab, Interferon Alfa-2a (IFN)
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
41
|
49
|
|
Overall Study
Death
|
13
|
10
|
|
Overall Study
Administrative Problems
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
7
|
|
Overall Study
Protocol Deviation
|
1
|
3
|
|
Overall Study
New Cancer Therapy
|
4
|
2
|
|
Overall Study
Disease Progression
|
104
|
107
|
Baseline Characteristics
Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab, RAD001 (Everolimus)
n=182 Participants
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
|
Bevacizumab, Interferon Alfa-2a (IFN)
n=183 Participants
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
|
Total
n=365 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.71 Years
STANDARD_DEVIATION 10.584 • n=5 Participants
|
59.93 Years
STANDARD_DEVIATION 10.272 • n=7 Participants
|
60.32 Years
STANDARD_DEVIATION 10.422 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.Population: Full Analysis Set: This set consists of all randomized participants.
Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.
Outcome measures
| Measure |
Bevacizumab, RAD001 (Everolimus)
n=182 Participants
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
|
Bevacizumab, Interferon Alfa-2a (IFN)
n=183 Participants
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|---|
|
Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
|
9.3 Months
Interval 8.1 to 11.2
|
10.0 Months
Interval 8.3 to 12.9
|
SECONDARY outcome
Timeframe: Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012)Population: Full Analysis Set: This set consists of all randomized participants.
Overall survival (OS) was defined as the time of randomization to the date of death due to any cause.
Outcome measures
| Measure |
Bevacizumab, RAD001 (Everolimus)
n=182 Participants
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
|
Bevacizumab, Interferon Alfa-2a (IFN)
n=183 Participants
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|---|
|
Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
|
27.1 Months
Interval 19.9 to 35.3
|
27.1 Months
Interval 20.4 to 30.8
|
SECONDARY outcome
Timeframe: Time from first participant randomized until 31Dec2011, cutoff date.Population: Full Analysis Set: This set consists of all randomized participants.
Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.
Outcome measures
| Measure |
Bevacizumab, RAD001 (Everolimus)
n=182 Participants
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
|
Bevacizumab, Interferon Alfa-2a (IFN)
n=183 Participants
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|---|
|
Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Complete response (CR)
|
0 Number of participants
|
1 Number of participants
|
|
Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Partial response (PR)
|
49 Number of participants
|
50 Number of participants
|
|
Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Stable disease (SD)
|
90 Number of participants
|
84 Number of participants
|
|
Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Progressive disease (PD)
|
25 Number of participants
|
26 Number of participants
|
|
Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Unknown response
|
18 Number of participants
|
22 Number of participants
|
|
Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Overall objective response (CR+PR)
|
49 Number of participants
|
51 Number of participants
|
SECONDARY outcome
Timeframe: Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date.Population: A subset of participants from the full analysis set were analyzed. The full analysis set consists of all randomized participants. the subset includes participants who were complete responders or partial responders.
The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment.
Outcome measures
| Measure |
Bevacizumab, RAD001 (Everolimus)
n=49 Participants
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
|
Bevacizumab, Interferon Alfa-2a (IFN)
n=51 Participants
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|---|
|
Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
|
13.3 Months
Interval 10.7 to 16.7
|
11.3 Months
Interval 10.4 to
The upper limit was not estimable as it is longer than the estimated time period per data cutoff (31Dec2011).
|
SECONDARY outcome
Timeframe: From the first participant randomized until the last patient discontinued the study treatment + 28 daysPopulation: Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.
Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle.
Outcome measures
| Measure |
Bevacizumab, RAD001 (Everolimus)
n=180 Participants
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
|
Bevacizumab, Interferon Alfa-2a (IFN)
n=181 Participants
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|---|
|
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths
Adverse events (serious and non-serious)
|
179 Participants
|
180 Participants
|
|
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths
Serious adverse events
|
79 Participants
|
76 Participants
|
|
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths
Deaths
|
93 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011Population: Full Analysis Set: This set consists of all randomized participants.
The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration is defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the participant.
Outcome measures
| Measure |
Bevacizumab, RAD001 (Everolimus)
n=182 Participants
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
|
Bevacizumab, Interferon Alfa-2a (IFN)
n=183 Participants
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|---|
|
Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units
|
7.4 Months
Interval 4.7 to 10.8
|
8.0 Months
Interval 3.7 to 11.5
|
SECONDARY outcome
Timeframe: Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011Population: Full Analysis Set: This set consists of all randomized participants.
The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the participant.
Outcome measures
| Measure |
Bevacizumab, RAD001 (Everolimus)
n=182 Participants
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
|
Bevacizumab, Interferon Alfa-2a (IFN)
n=183 Participants
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|---|
|
Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%
Global health status/QoL
|
7.4 Months
Interval 5.3 to 12.0
|
7.8 Months
Interval 5.6 to 10.2
|
|
Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%
Physical functioning
|
8.5 Months
Interval 5.6 to 13.8
|
9.0 Months
Interval 6.5 to 12.9
|
SECONDARY outcome
Timeframe: From the date of the first participant treated until the last patient discontinued the study treatment + 28 daysPopulation: Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.
This outcome measure was assessed continuously.
Outcome measures
| Measure |
Bevacizumab, RAD001 (Everolimus)
n=180 Participants
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
|
Bevacizumab, Interferon Alfa-2a (IFN)
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|---|
|
Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab
|
37.0 weeks
Interval 2.0 to 190.0
|
—
|
Adverse Events
Bevacizumab, RAD001 (Everolimus)
Serious events: 79 serious events
Other events: 173 other events
Deaths: 0 deaths
Bevacizumab, Interferon Alfa-2a (IFN)
Serious events: 76 serious events
Other events: 179 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab, RAD001 (Everolimus)
n=180 participants at risk
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
|
Bevacizumab, Interferon Alfa-2a (IFN)
n=181 participants at risk
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.3%
6/180
|
4.4%
8/181
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.56%
1/180
|
0.00%
0/181
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY MEDIASTINAL
|
0.00%
0/180
|
0.55%
1/181
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
1.1%
2/180
|
0.00%
0/181
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.56%
1/180
|
0.00%
0/181
|
|
Cardiac disorders
CARDIAC ARREST
|
0.56%
1/180
|
1.1%
2/181
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.7%
3/180
|
0.00%
0/181
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.56%
1/180
|
0.00%
0/181
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.7%
3/180
|
0.55%
1/181
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/180
|
0.55%
1/181
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/180
|
0.55%
1/181
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.00%
0/180
|
0.55%
1/181
|
|
Ear and labyrinth disorders
TINNITUS
|
0.56%
1/180
|
0.00%
0/181
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.56%
1/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
4.4%
8/180
|
1.7%
3/181
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/180
|
1.1%
2/181
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
ASCITES
|
1.1%
2/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/180
|
1.1%
2/181
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.8%
5/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
ENTERITIS
|
0.56%
1/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
GASTRIC FISTULA
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.56%
1/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
1.7%
3/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
MOUTH HAEMORRHAGE
|
0.00%
0/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
NAUSEA
|
2.2%
4/180
|
1.1%
2/181
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.56%
1/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
PANCREATITIS CHRONIC
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
PROCTITIS
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
RETROPERITONEUM CYST
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
SIGMOIDITIS
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
STOMATITIS
|
1.7%
3/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.56%
1/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
VOMITING
|
2.2%
4/180
|
1.1%
2/181
|
|
General disorders
ASTHENIA
|
0.56%
1/180
|
1.1%
2/181
|
|
General disorders
DISEASE PROGRESSION
|
0.56%
1/180
|
1.7%
3/181
|
|
General disorders
DRUG INEFFECTIVE
|
0.00%
0/180
|
0.55%
1/181
|
|
General disorders
FATIGUE
|
1.1%
2/180
|
1.7%
3/181
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
1.1%
2/180
|
2.2%
4/181
|
|
General disorders
GENERALISED OEDEMA
|
0.56%
1/180
|
0.00%
0/181
|
|
General disorders
HYPERPYREXIA
|
0.00%
0/180
|
0.55%
1/181
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.00%
0/180
|
0.55%
1/181
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/180
|
1.1%
2/181
|
|
General disorders
OEDEMA PERIPHERAL
|
0.56%
1/180
|
0.00%
0/181
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
0.56%
1/180
|
0.00%
0/181
|
|
General disorders
PYREXIA
|
1.7%
3/180
|
0.00%
0/181
|
|
General disorders
SUDDEN DEATH
|
0.56%
1/180
|
0.00%
0/181
|
|
Hepatobiliary disorders
BILE DUCT OBSTRUCTION
|
0.00%
0/180
|
0.55%
1/181
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/180
|
0.55%
1/181
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/180
|
0.55%
1/181
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.00%
0/180
|
0.55%
1/181
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.56%
1/180
|
0.00%
0/181
|
|
Hepatobiliary disorders
JAUNDICE
|
0.56%
1/180
|
0.00%
0/181
|
|
Infections and infestations
ANAL ABSCESS
|
1.7%
3/180
|
0.00%
0/181
|
|
Infections and infestations
BRONCHITIS
|
0.56%
1/180
|
0.00%
0/181
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.56%
1/180
|
0.55%
1/181
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
INJECTION SITE INFECTION
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
MYELITIS
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
NECROTISING FASCIITIS
|
0.56%
1/180
|
0.00%
0/181
|
|
Infections and infestations
OSTEOMYELITIS
|
0.56%
1/180
|
0.55%
1/181
|
|
Infections and infestations
PHARYNGITIS
|
0.56%
1/180
|
0.00%
0/181
|
|
Infections and infestations
PNEUMONIA
|
3.3%
6/180
|
1.1%
2/181
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
1.1%
2/180
|
0.55%
1/181
|
|
Infections and infestations
SEPSIS
|
2.2%
4/180
|
0.55%
1/181
|
|
Infections and infestations
SEPTIC SHOCK
|
0.56%
1/180
|
0.00%
0/181
|
|
Infections and infestations
SINUSITIS BACTERIAL
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
TONSILLITIS
|
0.56%
1/180
|
0.00%
0/181
|
|
Infections and infestations
TUBERCULOSIS
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.56%
1/180
|
1.7%
3/181
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.56%
1/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
CEMENT EMBOLISM
|
0.56%
1/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
0.56%
1/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/180
|
0.55%
1/181
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.56%
1/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
FRACTURE
|
0.56%
1/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
HEPATIC HAEMATOMA
|
0.00%
0/180
|
0.55%
1/181
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.56%
1/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/180
|
0.55%
1/181
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.56%
1/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.56%
1/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.56%
1/180
|
0.55%
1/181
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.00%
0/180
|
0.55%
1/181
|
|
Investigations
BLOOD CREATINE INCREASED
|
0.56%
1/180
|
0.00%
0/181
|
|
Investigations
BLOOD CREATININE INCREASED
|
1.7%
3/180
|
0.00%
0/181
|
|
Investigations
EJECTION FRACTION DECREASED
|
0.56%
1/180
|
0.00%
0/181
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/180
|
0.55%
1/181
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.56%
1/180
|
0.00%
0/181
|
|
Investigations
WEIGHT DECREASED
|
0.56%
1/180
|
1.1%
2/181
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.56%
1/180
|
0.00%
0/181
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
1.7%
3/180
|
2.2%
4/181
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.7%
3/180
|
1.7%
3/181
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.56%
1/180
|
0.00%
0/181
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
1.7%
3/180
|
0.55%
1/181
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.56%
1/180
|
0.00%
0/181
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.56%
1/180
|
0.55%
1/181
|
|
Metabolism and nutrition disorders
HYPERVOLAEMIA
|
0.00%
0/180
|
0.55%
1/181
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/180
|
0.55%
1/181
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
1.1%
2/180
|
0.00%
0/181
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.56%
1/180
|
0.00%
0/181
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.7%
3/180
|
1.7%
3/181
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.56%
1/180
|
0.00%
0/181
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.56%
1/180
|
2.2%
4/181
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.56%
1/180
|
2.8%
5/181
|
|
Musculoskeletal and connective tissue disorders
BONE LOSS
|
0.56%
1/180
|
0.00%
0/181
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.56%
1/180
|
0.55%
1/181
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.56%
1/180
|
0.00%
0/181
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.56%
1/180
|
0.00%
0/181
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.56%
1/180
|
0.00%
0/181
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/180
|
0.55%
1/181
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/180
|
1.7%
3/181
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.56%
1/180
|
0.00%
0/181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.00%
0/180
|
0.55%
1/181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INTESTINAL ADENOCARCINOMA
|
0.00%
0/180
|
0.55%
1/181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
|
0.00%
0/180
|
0.55%
1/181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
|
0.56%
1/180
|
0.00%
0/181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.56%
1/180
|
0.00%
0/181
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.56%
1/180
|
0.00%
0/181
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/180
|
0.55%
1/181
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/180
|
1.7%
3/181
|
|
Nervous system disorders
COMA
|
0.00%
0/180
|
0.55%
1/181
|
|
Nervous system disorders
CONVULSION
|
0.56%
1/180
|
0.55%
1/181
|
|
Nervous system disorders
DIZZINESS
|
0.56%
1/180
|
0.55%
1/181
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/180
|
0.55%
1/181
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/180
|
1.1%
2/181
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.56%
1/180
|
0.00%
0/181
|
|
Nervous system disorders
HEADACHE
|
1.1%
2/180
|
0.00%
0/181
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.56%
1/180
|
0.55%
1/181
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/180
|
1.1%
2/181
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.00%
0/180
|
0.55%
1/181
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/180
|
0.55%
1/181
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/180
|
1.1%
2/181
|
|
Psychiatric disorders
DELIRIUM
|
0.56%
1/180
|
0.00%
0/181
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/180
|
0.55%
1/181
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/180
|
0.55%
1/181
|
|
Psychiatric disorders
SOPOR
|
0.00%
0/180
|
0.55%
1/181
|
|
Renal and urinary disorders
BLADDER DILATATION
|
0.00%
0/180
|
0.55%
1/181
|
|
Renal and urinary disorders
NEPHROTIC SYNDROME
|
0.56%
1/180
|
0.55%
1/181
|
|
Renal and urinary disorders
OLIGURIA
|
0.56%
1/180
|
0.00%
0/181
|
|
Renal and urinary disorders
PROTEINURIA
|
0.56%
1/180
|
1.1%
2/181
|
|
Renal and urinary disorders
RENAL COLIC
|
0.56%
1/180
|
0.00%
0/181
|
|
Renal and urinary disorders
RENAL FAILURE
|
2.8%
5/180
|
0.55%
1/181
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
1.1%
2/180
|
0.00%
0/181
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/180
|
1.1%
2/181
|
|
Renal and urinary disorders
TUBULOINTERSTITIAL NEPHRITIS
|
0.56%
1/180
|
0.00%
0/181
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.56%
1/180
|
0.00%
0/181
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.56%
1/180
|
0.00%
0/181
|
|
Reproductive system and breast disorders
TESTICULAR PAIN
|
0.56%
1/180
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.56%
1/180
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/180
|
0.55%
1/181
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.56%
1/180
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
1.1%
2/180
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.56%
1/180
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
3.3%
6/180
|
1.7%
3/181
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/180
|
0.55%
1/181
|
|
Respiratory, thoracic and mediastinal disorders
EMPHYSEMA
|
0.00%
0/180
|
0.55%
1/181
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
2.8%
5/180
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
1.1%
2/180
|
1.1%
2/181
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.7%
3/180
|
1.1%
2/181
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.56%
1/180
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.56%
1/180
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.56%
1/180
|
1.1%
2/181
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.56%
1/180
|
0.55%
1/181
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.56%
1/180
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.56%
1/180
|
0.00%
0/181
|
|
Vascular disorders
ACCELERATED HYPERTENSION
|
0.00%
0/180
|
0.55%
1/181
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.56%
1/180
|
0.00%
0/181
|
|
Vascular disorders
HYPERTENSION
|
2.2%
4/180
|
1.7%
3/181
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
1.1%
2/180
|
1.1%
2/181
|
|
Vascular disorders
HYPOTENSION
|
0.56%
1/180
|
0.00%
0/181
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.56%
1/180
|
0.00%
0/181
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/180
|
0.55%
1/181
|
Other adverse events
| Measure |
Bevacizumab, RAD001 (Everolimus)
n=180 participants at risk
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
|
Bevacizumab, Interferon Alfa-2a (IFN)
n=181 participants at risk
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
19.4%
35/180
|
19.3%
35/181
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
2.2%
4/180
|
6.6%
12/181
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
2.2%
4/180
|
6.1%
11/181
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
3.9%
7/180
|
11.6%
21/181
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
8.9%
16/180
|
16.0%
29/181
|
|
Cardiac disorders
TACHYCARDIA
|
5.0%
9/180
|
1.1%
2/181
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
10.0%
18/180
|
10.5%
19/181
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.6%
10/180
|
5.0%
9/181
|
|
Gastrointestinal disorders
CONSTIPATION
|
16.7%
30/180
|
14.4%
26/181
|
|
Gastrointestinal disorders
DIARRHOEA
|
39.4%
71/180
|
26.0%
47/181
|
|
Gastrointestinal disorders
DRY MOUTH
|
1.7%
3/180
|
6.1%
11/181
|
|
Gastrointestinal disorders
DYSPEPSIA
|
4.4%
8/180
|
6.1%
11/181
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
1.7%
3/180
|
6.1%
11/181
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
7.2%
13/180
|
1.7%
3/181
|
|
Gastrointestinal disorders
NAUSEA
|
21.1%
38/180
|
27.6%
50/181
|
|
Gastrointestinal disorders
STOMATITIS
|
61.7%
111/180
|
23.2%
42/181
|
|
Gastrointestinal disorders
TOOTHACHE
|
8.9%
16/180
|
6.6%
12/181
|
|
Gastrointestinal disorders
VOMITING
|
13.9%
25/180
|
14.4%
26/181
|
|
General disorders
ASTHENIA
|
21.7%
39/180
|
34.3%
62/181
|
|
General disorders
CHILLS
|
2.2%
4/180
|
11.6%
21/181
|
|
General disorders
FATIGUE
|
31.7%
57/180
|
41.4%
75/181
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
2.8%
5/180
|
17.7%
32/181
|
|
General disorders
MALAISE
|
1.1%
2/180
|
6.1%
11/181
|
|
General disorders
OEDEMA PERIPHERAL
|
24.4%
44/180
|
9.9%
18/181
|
|
General disorders
PYREXIA
|
13.3%
24/180
|
34.8%
63/181
|
|
Infections and infestations
GINGIVITIS
|
5.6%
10/180
|
3.9%
7/181
|
|
Infections and infestations
INFLUENZA
|
5.6%
10/180
|
2.8%
5/181
|
|
Infections and infestations
SINUSITIS
|
5.6%
10/180
|
3.3%
6/181
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
10.0%
18/180
|
3.9%
7/181
|
|
Infections and infestations
URINARY TRACT INFECTION
|
8.9%
16/180
|
8.8%
16/181
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
5.0%
9/180
|
2.2%
4/181
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.6%
10/180
|
2.8%
5/181
|
|
Investigations
BLOOD CREATININE INCREASED
|
11.1%
20/180
|
3.9%
7/181
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
5.6%
10/180
|
7.2%
13/181
|
|
Investigations
WEIGHT DECREASED
|
28.3%
51/180
|
32.0%
58/181
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
26.7%
48/180
|
44.2%
80/181
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
22.2%
40/180
|
4.4%
8/181
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
10.0%
18/180
|
2.8%
5/181
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
2.8%
5/180
|
6.1%
11/181
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
13.3%
24/180
|
9.4%
17/181
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
1.7%
3/180
|
7.7%
14/181
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
18.3%
33/180
|
20.4%
37/181
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
12.2%
22/180
|
14.4%
26/181
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
4.4%
8/180
|
5.5%
10/181
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
5.0%
9/180
|
6.1%
11/181
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.1%
11/180
|
18.8%
34/181
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
13.9%
25/180
|
9.4%
17/181
|
|
Nervous system disorders
DIZZINESS
|
6.1%
11/180
|
6.6%
12/181
|
|
Nervous system disorders
DYSGEUSIA
|
11.7%
21/180
|
3.9%
7/181
|
|
Nervous system disorders
HEADACHE
|
20.0%
36/180
|
21.0%
38/181
|
|
Psychiatric disorders
DEPRESSION
|
4.4%
8/180
|
13.8%
25/181
|
|
Psychiatric disorders
INSOMNIA
|
12.8%
23/180
|
13.8%
25/181
|
|
Renal and urinary disorders
DYSURIA
|
5.6%
10/180
|
5.5%
10/181
|
|
Renal and urinary disorders
PROTEINURIA
|
50.0%
90/180
|
37.6%
68/181
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
30.0%
54/180
|
18.8%
34/181
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
6.1%
11/180
|
5.0%
9/181
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
15.6%
28/180
|
17.7%
32/181
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
34.4%
62/180
|
21.0%
38/181
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
10.0%
18/180
|
3.9%
7/181
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
6.7%
12/180
|
0.55%
1/181
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
7.2%
13/180
|
5.0%
9/181
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
7.2%
13/180
|
1.1%
2/181
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
5.0%
9/180
|
0.55%
1/181
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
12.2%
22/180
|
8.8%
16/181
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
17.2%
31/180
|
12.2%
22/181
|
|
Skin and subcutaneous tissue disorders
RASH
|
23.3%
42/180
|
11.0%
20/181
|
|
Vascular disorders
HYPERTENSION
|
37.2%
67/180
|
21.5%
39/181
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER