Trial Outcomes & Findings for Phase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China (NCT NCT02842749)
NCT ID: NCT02842749
Last Updated: 2025-02-10
Results Overview
Number of participants with treatment emergent adverse events (any AE regardless of seriousness), SAEs, AEs and SAEs on grade 3 or 4, and suspected to be related to the study drug.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period of 30 days, up to a maximum duration of approximately 5 years.
Results posted on
2025-02-10
Participant Flow
Participants took part in 5 investigative sites in China.
Participant milestones
| Measure |
Everolimus
Participants were instructed to take everolimus at a starting dose of 10 mg orally once daily. However, dose adjustments were permitted in order to allow the participant to continue the study treatment.
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China
Baseline characteristics by cohort
| Measure |
Everolimus
n=61 Participants
Participants were instructed to take everolimus at a starting dose of 10 mg orally once daily. However, dose adjustments were permitted in order to allow the participant to continue the study treatment.
|
|---|---|
|
Age, Continuous
|
53.22 years
STANDARD_DEVIATION 14.305 • n=99 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
61 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period of 30 days, up to a maximum duration of approximately 5 years.Population: Safety Analysis Set (SS): including all participants who received at least one study treatment. Participants were analyzed according to the treatment they actually received.
Number of participants with treatment emergent adverse events (any AE regardless of seriousness), SAEs, AEs and SAEs on grade 3 or 4, and suspected to be related to the study drug.
Outcome measures
| Measure |
Everolimus
n=61 Participants
Participants were instructed to take everolimus at a starting dose of 10 mg orally once daily. However, dose adjustments were permitted in order to allow the participant to continue the study treatment.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
60 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs-grade 3/4
|
30 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs Suspected to be related to the study drug
|
58 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs Suspected to be related to the study drug-grade 3/4
|
19 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
17 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs-grade 3/4
|
11 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs Suspected to be related to the study drug
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs Suspected to be related to the study drug-grade 3/4
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 7 years and 6 months.Population: Full Analysis Set (FAS): including all participants who received at least one study treatment. Participants were analyzed according to the treatment they actually received.
Overall Survival is defined as the time from the start of study treatment to death due to any cause. OS was analyzed using the Kaplan-Meier method.
Outcome measures
| Measure |
Everolimus
n=61 Participants
Participants were instructed to take everolimus at a starting dose of 10 mg orally once daily. However, dose adjustments were permitted in order to allow the participant to continue the study treatment.
|
|---|---|
|
Overall Survival (OS)
|
66.56 months
Interval 39.66 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 2 years and 9 monthsPopulation: Full Analysis Set (FAS): including all participants who received at least one study treatment. Participants were analyzed according to the treatment they actually received.
Progression free survival is defined as the time from the initiation of study treatment to disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier estimates.
Outcome measures
| Measure |
Everolimus
n=61 Participants
Participants were instructed to take everolimus at a starting dose of 10 mg orally once daily. However, dose adjustments were permitted in order to allow the participant to continue the study treatment.
|
|---|---|
|
Progression Free Survival (PFS) by Investigator Assessment Per RECIST 1.1
|
16.07 months
Interval 11.04 to 21.52
|
Adverse Events
Everolimus-on Treatment
Serious events: 17 serious events
Other events: 60 other events
Deaths: 6 deaths
Everolimus-Survival Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Everolimus-on Treatment
n=61 participants at risk
AEs collected from randomization up to 30 days post-treatment
|
Everolimus-Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
|
|---|---|---|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Metabolism and nutrition disorders
Cachexia
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Hepatobiliary disorders
Function liver abnormal
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Infections and infestations
Infectious pneumonitis
|
4.9%
3/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Infections and infestations
Anal abscess
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Infections and infestations
Sepsis
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Infections and infestations
Herpes virus infection
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Nervous system disorders
Hemorrhage cerebral
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Nervous system disorders
Hypoglycemic encephalopathy
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Nervous system disorders
Movement disorder
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor rupture
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
General disorders
Asthenia
|
3.3%
2/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
General disorders
Fever
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
General disorders
Death
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Renal and urinary disorders
Renal failure
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
Other adverse events
| Measure |
Everolimus-on Treatment
n=61 participants at risk
AEs collected from randomization up to 30 days post-treatment
|
Everolimus-Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.0%
11/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.8%
9/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.8%
9/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
13.1%
8/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.1%
8/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
11.5%
7/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.5%
7/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.2%
5/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
8.2%
5/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.6%
4/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.6%
4/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
44.3%
27/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Alanine aminotransferase increased
|
29.5%
18/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
White blood cell count decreased
|
26.2%
16/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Neutrophil count decreased
|
24.6%
15/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Platelet count decreased
|
23.0%
14/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Blood glucose increased
|
21.3%
13/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Weight decreased
|
14.8%
9/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.8%
9/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
11.5%
7/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Blood albumin decreased
|
11.5%
7/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
White blood cell count increased
|
9.8%
6/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Lymphocyte count decreased
|
9.8%
6/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Blood cholesterol increased
|
9.8%
6/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Blood lactate dehydrogenase increased
|
9.8%
6/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Low density lipoprotein increased
|
8.2%
5/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Haemoglobin decreased
|
8.2%
5/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Neutrophil count increased
|
8.2%
5/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
6.6%
4/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Protein urine present
|
6.6%
4/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Blood bilirubin increased
|
6.6%
4/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Blood triglycerides increased
|
6.6%
4/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Investigations
Blood creatinine increased
|
6.6%
4/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Infections and infestations
Infectious pneumonitis
|
9.8%
6/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Nervous system disorders
Headache
|
6.6%
4/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.7%
12/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
18.0%
11/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.6%
15/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
6/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
General disorders
Pyrexia
|
21.3%
13/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
General disorders
Oedema peripheral
|
21.3%
13/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
General disorders
Asthenia
|
21.3%
13/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Renal and urinary disorders
Proteinuria
|
14.8%
9/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Gastrointestinal disorders
Mouth ulceration
|
39.3%
24/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
37.7%
23/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
36.1%
22/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.2%
5/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Gastrointestinal disorders
Vomiting
|
8.2%
5/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.6%
4/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.6%
4/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Vascular disorders
Hypertension
|
14.8%
9/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
49.2%
30/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
|
Eye disorders
Eyelid oedema
|
6.6%
4/61 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
—
0/0 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days (on treatment period), up to a maximum duration of approximately 5 years. All cause mortality was reported until end of study, up to approximately 7 years and 6 months (on treatment plus survival follow-up period).
Adverse events were only collected in the on treatment period. Deaths in the post treatment survival follow up period are not considered AEs.
|
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER