Trial Outcomes & Findings for BGJ398 for Patients With Tumors With FGFR Genetic Alterations (NCT NCT02160041)
NCT ID: NCT02160041
Last Updated: 2019-06-18
Results Overview
Tumor Response: Overall response rate (ORR) and clinical benefit rate (CBR) for solid tumor (non-lymphoma) which excludes 3 TIO and 1 Lymphoma patients (hence 80 patients and not 84) Clinical benefit rate for patients with solid tumors were assessed using RECIST 1.1 and include responses of CR or PR or SD. For hematologic tumors other appropriate hematological response criteria may apply Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
16 weeks
Results posted on
2019-06-18
Participant Flow
Participant milestones
| Measure |
BGJ398
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
|
|---|---|
|
Overall Study
STARTED
|
84
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
84
|
Reasons for withdrawal
| Measure |
BGJ398
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Death
|
2
|
|
Overall Study
disease progression
|
57
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
non-compliance with study
|
1
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
study terminated by by sponsor
|
1
|
Baseline Characteristics
BGJ398 for Patients With Tumors With FGFR Genetic Alterations
Baseline characteristics by cohort
| Measure |
BGJ398
n=84 Participants
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
|
|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 12.08 • n=5 Participants
|
|
Age, Customized
<65 years
|
54 Participants
n=5 Participants
|
|
Age, Customized
>=65-<75 years
|
21 Participants
n=5 Participants
|
|
Age, Customized
>=75 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Full Analysis Set (FAS): The FAS included all enrolled patients who received at least 1 dose of study drug. The FAS was the primary set for efficacy analyses.
Tumor Response: Overall response rate (ORR) and clinical benefit rate (CBR) for solid tumor (non-lymphoma) which excludes 3 TIO and 1 Lymphoma patients (hence 80 patients and not 84) Clinical benefit rate for patients with solid tumors were assessed using RECIST 1.1 and include responses of CR or PR or SD. For hematologic tumors other appropriate hematological response criteria may apply Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
BGJ398
n=80 Participants
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
|
|---|---|
|
Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment
Complete response (CR)
|
0 Participants
|
|
Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment
Partial response (PR)
|
6 Participants
|
|
Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment
Progressive disease (PD)
|
54 Participants
|
|
Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment
Stable disease (SD)
|
7 Participants
|
|
Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment
Non-evaluable (NE)
|
13 Participants
|
|
Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment
Overall response rate (ORR: CR + PR)
|
6 Participants
|
|
Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment
Clinical benefit rate (CBR: CR+PR+SD)
|
12 Participants
|
SECONDARY outcome
Timeframe: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 monthsPopulation: FAS
The key secondary endpoint, OR, was determined by Investigator assessment for each tumor assessment and defined as responses of CR and PR per RECIST version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
BGJ398
n=84 Participants
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
|
|---|---|
|
Overall Response (OR) or Partial Response (PR) or Greater
|
6 participants
Interval 2.8 to 15.6
|
SECONDARY outcome
Timeframe: every 8 weeks until death, assessed up to 24 monthsPopulation: FAS
Kaplan-Meier estimates of PFS timing, months Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause
Outcome measures
| Measure |
BGJ398
n=82 Participants
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
|
|---|---|
|
Progression-Free Survival (PFS)
|
1.8 months
Interval 1.8 to 2.0
|
SECONDARY outcome
Timeframe: Months 1, 2, 3, 4, 5, 6, 12, 18, 24Population: FAS
Outcome measures
| Measure |
BGJ398
n=82 Participants
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
|
|---|---|
|
Kaplan-Meier Estimates of PFS Rate, % (95% CI)
Month 1
|
88.0 percent of participants
Interval 78.2 to 93.6
|
|
Kaplan-Meier Estimates of PFS Rate, % (95% CI)
Month 2
|
38.0 percent of participants
Interval 27.0 to 48.9
|
|
Kaplan-Meier Estimates of PFS Rate, % (95% CI)
Month 3
|
32.3 percent of participants
Interval 21.9 to 43.0
|
|
Kaplan-Meier Estimates of PFS Rate, % (95% CI)
Month 4
|
20.0 percent of participants
Interval 11.5 to 30.1
|
|
Kaplan-Meier Estimates of PFS Rate, % (95% CI)
Month 5
|
15.4 percent of participants
Interval 8.0 to 24.9
|
|
Kaplan-Meier Estimates of PFS Rate, % (95% CI)
Month 6
|
12.3 percent of participants
Interval 5.8 to 21.3
|
|
Kaplan-Meier Estimates of PFS Rate, % (95% CI)
Month 12
|
10.2 percent of participants
Interval 4.3 to 19.2
|
|
Kaplan-Meier Estimates of PFS Rate, % (95% CI)
Month 18
|
6.1 percent of participants
Interval 1.8 to 14.5
|
|
Kaplan-Meier Estimates of PFS Rate, % (95% CI)
Month 24
|
0.0 percent of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: every 8 weeks until death, assessed up to 36 monthsPopulation: FAS
Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause
Outcome measures
| Measure |
BGJ398
n=84 Participants
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
|
|---|---|
|
Overall Survival (OS)
|
6.2 months
Interval 4.4 to 9.8
|
SECONDARY outcome
Timeframe: months 3, 6, 9, 12, 24Population: FAS
Overall survival (OS) is the time from the date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact.
Outcome measures
| Measure |
BGJ398
n=84 Participants
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
|
|---|---|
|
Kaplan-Meier Estimates of Survival Rate, % (95% CI)
Month 3
|
75.9 percent of participants
Interval 64.9 to 83.9
|
|
Kaplan-Meier Estimates of Survival Rate, % (95% CI)
Month 6
|
50.1 percent of participants
Interval 38.6 to 60.6
|
|
Kaplan-Meier Estimates of Survival Rate, % (95% CI)
Month 9
|
39.4 percent of participants
Interval 28.5 to 50.1
|
|
Kaplan-Meier Estimates of Survival Rate, % (95% CI)
Month 12
|
35.1 percent of participants
Interval 24.6 to 45.8
|
|
Kaplan-Meier Estimates of Survival Rate, % (95% CI)
Month 24
|
19.5 percent of participants
Interval 10.5 to 30.5
|
SECONDARY outcome
Timeframe: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 monthsPopulation: FAS
The duration of response (PR or greater) applies only to patients whose best response was PR or greater. It is defined as the Ttime from the first documented response to the date first documented disease progression or relapse or death due to any cause
Outcome measures
| Measure |
BGJ398
n=84 Participants
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
|
|---|---|
|
Number of Participants With 99 Day Minimum Duration of Response (DOR)
|
6 Participants
|
Adverse Events
BGJ398
Serious events: 33 serious events
Other events: 81 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
BGJ398
n=83 participants at risk
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
3/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
2/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
2/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Dysphagia
|
2.4%
2/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Enterovesical fistula
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Haematemesis
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
2.4%
2/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Nausea
|
3.6%
3/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
2/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
General disorders
Asthenia
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
General disorders
Chest pain
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
General disorders
Fatigue
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
General disorders
Malaise
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
General disorders
Pyrexia
|
2.4%
2/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Hepatobiliary disorders
Bile duct obstruction
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Infections and infestations
Pneumonia
|
2.4%
2/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Infections and infestations
Sepsis
|
4.8%
4/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Infections and infestations
Septic shock
|
2.4%
2/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Infections and infestations
Soft tissue infection
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Infections and infestations
Urinary tract infection
|
3.6%
3/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Investigations
Blood creatinine increased
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Investigations
Platelet count decreased
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Cachexia
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
2/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.4%
2/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
2/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal neoplasm
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Nervous system disorders
Coma
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Nervous system disorders
Spinal cord compression
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Nervous system disorders
Syncope
|
2.4%
2/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Renal and urinary disorders
Obstructive uropathy
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
4/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.4%
2/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Vascular disorders
Hypotension
|
1.2%
1/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
Other adverse events
| Measure |
BGJ398
n=83 participants at risk
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.8%
9/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Eye disorders
Dry eye
|
19.3%
16/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Eye disorders
Punctate keratitis
|
6.0%
5/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Abdominal distension
|
8.4%
7/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
14.5%
12/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Constipation
|
31.3%
26/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
24.1%
20/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Dry mouth
|
26.5%
22/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
12.0%
10/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Dysphagia
|
7.2%
6/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Glossodynia
|
6.0%
5/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Nausea
|
31.3%
26/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Oral pain
|
7.2%
6/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Stomatitis
|
26.5%
22/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Gastrointestinal disorders
Vomiting
|
18.1%
15/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
General disorders
Asthenia
|
6.0%
5/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
General disorders
Fatigue
|
53.0%
44/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
General disorders
Mucosal inflammation
|
18.1%
15/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
General disorders
Oedema peripheral
|
7.2%
6/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
General disorders
Pyrexia
|
8.4%
7/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Infections and infestations
Conjunctivitis
|
9.6%
8/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Infections and infestations
Sinusitis
|
7.2%
6/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Infections and infestations
Urinary tract infection
|
14.5%
12/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Investigations
Alanine aminotransferase increased
|
9.6%
8/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Investigations
Aspartate aminotransferase increased
|
12.0%
10/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Investigations
Blood alkaline phosphatase increased
|
10.8%
9/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Investigations
Blood creatinine increased
|
20.5%
17/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Investigations
Blood phosphorus increased
|
16.9%
14/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.0%
5/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Investigations
Lipase increased
|
6.0%
5/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Investigations
Weight decreased
|
18.1%
15/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.9%
19/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
14.5%
12/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.2%
6/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
56.6%
47/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.0%
5/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.2%
6/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.5%
12/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.0%
10/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.0%
10/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.2%
6/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.4%
7/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.4%
7/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.4%
7/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.0%
10/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Nervous system disorders
Dizziness
|
7.2%
6/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Nervous system disorders
Dysgeusia
|
20.5%
17/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Nervous system disorders
Headache
|
7.2%
6/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Nervous system disorders
Neuropathy peripheral
|
6.0%
5/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Psychiatric disorders
Insomnia
|
7.2%
6/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
8/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.8%
9/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.0%
5/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.1%
15/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.6%
8/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
6.0%
5/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
9.6%
8/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
6.0%
5/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.2%
6/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
|
Vascular disorders
Hypotension
|
7.2%
6/83 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to maximum of 26.6 months
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 26.6 months
|
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