Trial Outcomes & Findings for Everolimus Post Pazopanib Treatment in Metastatic or Advanced Renal Cell Carcinoma (NCT NCT01545817)
NCT ID: NCT01545817
Last Updated: 2019-10-09
Results Overview
Time between the date of first everolimus dose and date of disease progression or death (whichever comes first) in patients treated initially with pazopanib. Disease progression is measured by RECIST (Response Evaluation Criteria in Solid Tumors), which is at least a 20% increase in the sum of the target lesion longest diameters (LDs).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
Throughout the study period, up to 4 years
Results posted on
2019-10-09
Participant Flow
A total of 74 patients were enrolled, all started first-line pazopanib treatment. Of these, 51 discontinued pazopanib and 38 continued to second-line everolimus treatment
Participant milestones
| Measure |
Pazopanib
All patients were assigned to first-line treatment with pazopanib once daily. Pazopanib was supplied as 200 mg and 400 mg tablets. Pazopanib was administered once daily at the approved recommended dose of 800 mg/day (two 400 mg tablets, treatment taken once daily). The 200 mg tablets were provided to patients who needed dose adjustment.
|
Everolimus
Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment. Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments.
|
|---|---|---|
|
Pazopanib
STARTED
|
74
|
0
|
|
Pazopanib
COMPLETED
|
0
|
0
|
|
Pazopanib
NOT COMPLETED
|
74
|
0
|
|
Everolimus
STARTED
|
0
|
38
|
|
Everolimus
COMPLETED
|
0
|
0
|
|
Everolimus
NOT COMPLETED
|
0
|
38
|
Reasons for withdrawal
| Measure |
Pazopanib
All patients were assigned to first-line treatment with pazopanib once daily. Pazopanib was supplied as 200 mg and 400 mg tablets. Pazopanib was administered once daily at the approved recommended dose of 800 mg/day (two 400 mg tablets, treatment taken once daily). The 200 mg tablets were provided to patients who needed dose adjustment.
|
Everolimus
Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment. Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments.
|
|---|---|---|
|
Pazopanib
Disease progression
|
51
|
0
|
|
Pazopanib
Adverse Event
|
19
|
0
|
|
Pazopanib
Other reason
|
4
|
0
|
|
Everolimus
Other reason
|
0
|
7
|
|
Everolimus
Disease progression
|
0
|
25
|
|
Everolimus
Adverse Event
|
0
|
6
|
Baseline Characteristics
Everolimus Post Pazopanib Treatment in Metastatic or Advanced Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
All Patients
n=74 Participants
All patients were assigned to first-line treatment with pazopanib once daily. Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily as second-line treatment.
|
|---|---|
|
Age, Continuous
|
66.0 Years
STANDARD_DEVIATION 10.68 • n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Throughout the study period, up to 4 yearsPopulation: Intent to treat (ITT) population included all patients who received at least one dose of pazopanib and at least one dose of everolimus.
Time between the date of first everolimus dose and date of disease progression or death (whichever comes first) in patients treated initially with pazopanib. Disease progression is measured by RECIST (Response Evaluation Criteria in Solid Tumors), which is at least a 20% increase in the sum of the target lesion longest diameters (LDs).
Outcome measures
| Measure |
Everolimus
n=38 Participants
Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment. Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments.
|
|---|---|
|
Progression Free Survival (PFS) for the Everolimus Treatment Period Using RECIST
|
5.1 months
Interval 3.4 to 6.8
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsPopulation: Intent to treat (ITT) population included all patients who received at least one dose of pazopanib and at least one dose of everolimus.
PFS rates 3 and 6 months after date of first dose of second-line everolimus treatment.
Outcome measures
| Measure |
Everolimus
n=38 Participants
Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment. Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments.
|
|---|---|
|
Progression Free Survival (PFS) Rates
3 months
|
0.737 Survival probability
Interval 0.554 to 0.854
|
|
Progression Free Survival (PFS) Rates
6 months
|
0.355 Survival probability
Interval 0.196 to 0.517
|
SECONDARY outcome
Timeframe: Throughout the study, up to 4 yearsPopulation: Intent to treat (ITT) population included all patients who received at least one dose of pazopanib and at least one dose of everolimus.
Percentage of patients with Complete or Partial Response at any time following the start of second-line everolimus treatment as per RECIST. RECIST Complete Response is defined to be a disappearance of all target lesion(s). RECIST Partial Response is defined to be at least a 30% decrease in the sum of the target lesion LDs.
Outcome measures
| Measure |
Everolimus
n=38 Participants
Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment. Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments.
|
|---|---|
|
Objective Response Rate (ORR) for the Everolimus Treatment Period Using RECIST
Complete response
|
0.0 Percentages of Participants
Interval 0.0 to 9.3
|
|
Objective Response Rate (ORR) for the Everolimus Treatment Period Using RECIST
Partial response
|
7.9 Percentages of Participants
Interval 1.7 to 21.4
|
SECONDARY outcome
Timeframe: Throughout the study period, up to 4 yearsPopulation: Intent to treat (ITT) population included all patients who received at least one dose of pazopanib and at least one dose of everolimus.
Percentage of patients with Complete or Partial Response at any time following the start of first-line pazopanib treatment. RECIST Complete Response is defined to be a disappearance of all target lesion(s). RECIST Partial Response is defined to be at least a 30% decrease in the sum of the target lesion LDs.
Outcome measures
| Measure |
Everolimus
n=74 Participants
Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment. Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments.
|
|---|---|
|
Objective Response Rate (ORR) for the Pazopanib Treatment Period Using RECIST
Complete response
|
6.8 Percentages of participants
Interval 2.2 to 15.1
|
|
Objective Response Rate (ORR) for the Pazopanib Treatment Period Using RECIST
Partial response
|
39.2 Percentages of participants
Interval 28.0 to 51.2
|
SECONDARY outcome
Timeframe: Throughout the study period, up to 4 yearsPopulation: ITT
Time from first everolimus dose until death due to any cause
Outcome measures
| Measure |
Everolimus
n=38 Participants
Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment. Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments.
|
|---|---|
|
Overall Survival of Everolimus (OSE)
|
15.6 months
Interval 9.9 to 25.3
|
SECONDARY outcome
Timeframe: Throughout the study, up to 4 yearsPopulation: ATS
Time from first pazopanib dose until death due to any cause in patients who received at least one dose of pazopanib followed by everolimus
Outcome measures
| Measure |
Everolimus
n=74 Participants
Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment. Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments.
|
|---|---|
|
Overall Survival From the Start (OSS) of Study Treatment
|
35.7 Months
Interval 26.7 to
not reached due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Throughout the study period, up to 4 yearsPopulation: ATS
Time from first pazopanib dose until disease progression or death from any cause (whichever occurred earlier), provided this occurred prior to the start of everolimus and within 6 months of last dose of pazopanib
Outcome measures
| Measure |
Everolimus
n=74 Participants
Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment. Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments.
|
|---|---|
|
PFS for the Pazopanib Treatment Period Using RECIST
|
11.0 Months
Interval 7.2 to 14.8
|
Adverse Events
Pazopanib
Serious events: 47 serious events
Other events: 73 other events
Deaths: 5 deaths
Everolimus
Serious events: 16 serious events
Other events: 34 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Pazopanib
n=74 participants at risk
All patients were assigned to first-line treatment with pazopanib once daily. Pazopanib was supplied as 200 mg and 400 mg tablets. Pazopanib was administered once daily at the approved recommended dose of 800 mg/day (two 400 mg tablets, treatment taken once daily). The 200 mg tablets were provided to patients who needed dose adjustment.
|
Everolimus
n=38 participants at risk
Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment.
Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Cardiac disorders
Cardiac Arrest
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Cardiac disorders
Myocardial Infarction
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Eye disorders
Retinal Detachment
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Enteritis
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Haematochezia
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Pancreatic Pseudocyst
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Volvulus
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
2/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Fatigue
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Incarcerated Hernia
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Malaise
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Oedema Peripheral
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Pain
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Hepatobiliary disorders
Liver Injury
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Immune system disorders
Anaphylactic Reaction
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Abscess Neck
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Anal Abscess
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Cellulitis
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Diverticulitis
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Gastroenteritis
|
2.7%
2/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Herpes Zoster
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Otitis Externa
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Pancreas Infection
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Pneumonia
|
2.7%
2/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
10.5%
4/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Pulmonary Sepsis
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Rectal Abscess
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Septic Shock
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Urinary Tract Infection
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Wound Infection
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Investigations
Alanine Aminotransferase Increased
|
8.1%
6/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Investigations
Liver Function Test Abnormal
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.7%
2/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Aphasia
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Ataxia
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Sciatica
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Seizure
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Spinal Cord Compression
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Syncope
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Vagus Nerve Paralysis
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Psychiatric disorders
Delirium
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Renal and urinary disorders
Azotaemia
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Renal and urinary disorders
Dysuria
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Renal and urinary disorders
Haematuria
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
2/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.7%
2/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Vascular disorders
Hypertension
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
Other adverse events
| Measure |
Pazopanib
n=74 participants at risk
All patients were assigned to first-line treatment with pazopanib once daily. Pazopanib was supplied as 200 mg and 400 mg tablets. Pazopanib was administered once daily at the approved recommended dose of 800 mg/day (two 400 mg tablets, treatment taken once daily). The 200 mg tablets were provided to patients who needed dose adjustment.
|
Everolimus
n=38 participants at risk
Patients who progressed during or within 6 months after stopping pazopanib treatment were eligible to then receive everolimus once daily (10 mg) as second-line treatment.
Everolimus was supplied to the study sites as 5 mg and 10 mg tablets. The 5 mg tablets were provided to patients who needed dose adjustments.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.1%
3/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
23.7%
9/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Cardiac disorders
Palpitations
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Endocrine disorders
Hypothyroidism
|
10.8%
8/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.3%
15/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Constipation
|
16.2%
12/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
10.5%
4/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
60.8%
45/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
18.9%
14/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Dysphagia
|
2.7%
2/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
12.2%
9/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
4.1%
3/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
10.5%
4/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
37/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
15.8%
6/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Stomatitis
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
18.4%
7/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Gastrointestinal disorders
Vomiting
|
23.0%
17/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
13.2%
5/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Asthenia
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Chest Pain
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Fatigue
|
59.5%
44/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
10.5%
4/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Gait Disturbance
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
7.9%
3/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Influenza Like Illness
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Mucosal Inflammation
|
10.8%
8/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
15.8%
6/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Oedema Peripheral
|
9.5%
7/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
18.4%
7/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Peripheral Swelling
|
6.8%
5/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
General disorders
Pyrexia
|
9.5%
7/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
7.9%
3/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
13.5%
10/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Infections and infestations
Urinary Tract Infection
|
12.2%
9/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
7.9%
3/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
7.9%
3/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Investigations
Alanine Aminotransferase Increased
|
8.1%
6/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.8%
5/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Investigations
Blood Creatinine Increased
|
2.7%
2/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Investigations
Weight Decreased
|
16.2%
12/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
27.0%
20/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
13.2%
5/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.7%
2/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
18.4%
7/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
7.9%
3/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypophagia
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.3%
15/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
10.5%
4/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.3%
15/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
2.7%
2/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
10.5%
4/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
9.5%
7/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
8.1%
6/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
10.8%
8/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
8.1%
6/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
9.5%
7/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Balance Disorder
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Dizziness
|
6.8%
5/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Dysgeusia
|
24.3%
18/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Headache
|
17.6%
13/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
7.9%
3/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Lethargy
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Presyncope
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Nervous system disorders
Tremor
|
6.8%
5/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Psychiatric disorders
Depression
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Psychiatric disorders
Insomnia
|
9.5%
7/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.6%
16/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
18.4%
7/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.8%
5/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.6%
13/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
7.9%
3/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
8.1%
6/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
7.9%
3/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.8%
8/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
21.1%
8/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.4%
4/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.8%
5/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
10.5%
4/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
9.5%
7/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.1%
6/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
9.5%
7/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
2.6%
1/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Hair Colour Changes
|
23.0%
17/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
13.5%
10/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
1/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
7.9%
3/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.9%
14/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
21.1%
8/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
6.8%
5/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
5.3%
2/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Vascular disorders
Hypertension
|
32.4%
24/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
|
Vascular disorders
Hypotension
|
6.8%
5/74 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
0.00%
0/38 • Adverse events for each intervention were assessed from the time of first dose of treatment to approximately one month after discontinuation of the last dose of treatment, up to 4 years.
|
Additional Information
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER