Trial Outcomes & Findings for A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer (NCT NCT01379534)
NCT ID: NCT01379534
Last Updated: 2015-05-20
Results Overview
The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as "failure". Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
up to 18 weeks
Results posted on
2015-05-20
Participant Flow
Participants were treated with TKI258 until disease progression, unacceptable toxicity, death or discontinuation due to any other reason. All participants were followed for at least 30 days after their last dose of study drug for safety assessment.
If a participant didn't discontinue study drug due to disease progression, death, lost to follow-up or withdrawn consent to post treatment tumor assessment, then tumor assessments continued every 6 weeks until the start of new anti-cancer therapy, disease progression, death, lost to follow-up or withdrawn consent to tumor status follow-up.
Participant milestones
| Measure |
FGFR2 (MUT)
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
FGFR2 (WT)
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
|---|---|---|
|
Treatment Phase
STARTED
|
22
|
31
|
|
Treatment Phase
COMPLETED
|
0
|
0
|
|
Treatment Phase
NOT COMPLETED
|
22
|
31
|
|
Tumor Assessment Follow-up (f/u) Phase
STARTED
|
4
|
2
|
|
Tumor Assessment Follow-up (f/u) Phase
COMPLETED
|
0
|
0
|
|
Tumor Assessment Follow-up (f/u) Phase
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
FGFR2 (MUT)
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
FGFR2 (WT)
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
|---|---|---|
|
Treatment Phase
Withdrawal by Subject
|
2
|
2
|
|
Treatment Phase
Progressive disease
|
13
|
22
|
|
Treatment Phase
Adverse Event
|
7
|
7
|
|
Tumor Assessment Follow-up (f/u) Phase
Death
|
0
|
1
|
|
Tumor Assessment Follow-up (f/u) Phase
Progressive disease
|
3
|
0
|
|
Tumor Assessment Follow-up (f/u) Phase
Lost to Follow-up
|
0
|
1
|
|
Tumor Assessment Follow-up (f/u) Phase
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer
Baseline characteristics by cohort
| Measure |
FGFR2 (MUT)
n=22 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
FGFR2 (WT)
n=31 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 Years
STANDARD_DEVIATION 10.54 • n=5 Participants
|
64.4 Years
STANDARD_DEVIATION 8.63 • n=7 Participants
|
63.4 Years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
|
Sex/Gender, Customized
|
22 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 18 weeksPopulation: Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.
The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as "failure". Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Outcome measures
| Measure |
FGFR2 (MUT)
n=22 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
FGFR2 (WT)
n=31 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
|---|---|---|
|
Progression Free Survival (PFS) Rate
|
31.8 Percentage of participants
|
29.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and every 6 weeks until disease progression, up to 18 weeksPopulation: Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.
ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).
Outcome measures
| Measure |
FGFR2 (MUT)
n=22 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
FGFR2 (WT)
n=31 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
4.5 Percentage of participants
|
16.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and every 6 weeks until disease progression, up to 18 weeksPopulation: Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.
DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).
Outcome measures
| Measure |
FGFR2 (MUT)
n=22 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
FGFR2 (WT)
n=31 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
63.6 Percentage of participants
|
51.6 Percentage of participants
|
SECONDARY outcome
Timeframe: up to 18 weeksPopulation: This outcome measure was not analyzed. The analysis was not required because there were too few responders.
Duration of response was defined for participants with a CR or PR as the time from the date of the first documented response (CR or PR) to the date of the first documented progression or death due to disease. If a participants did not have a progression event, duration of response was censored at the date of the last adequate tumor assessment before the data analysis cut-off date or the antineoplastic therapy start date or the death date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 18 weeksPopulation: Full Analysis Set (FAS): The FAS included all participants who received at least one dose of study medication.
OS was defined as the time from date of treatment to the date of death from any cause. If a participant was not known to have died at the date of analysis cut-off, the OS was censored at the last date of contact.
Outcome measures
| Measure |
FGFR2 (MUT)
n=22 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
FGFR2 (WT)
n=31 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
|---|---|---|
|
Overall Survival (OS)
|
20.2 Months
Interval 8.2 to 20.2
|
9.3 Months
Interval 6.0 to 15.2
|
SECONDARY outcome
Timeframe: up to 18 weeksPopulation: Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.
PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate response assessment before the data analysis cut-off date or the start date of new antineoplastic therapy after study drug discontinuation.
Outcome measures
| Measure |
FGFR2 (MUT)
n=22 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
FGFR2 (WT)
n=31 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
4.1 Months
Interval 2.6 to 5.5
|
2.7 Months
Interval 1.4 to 6.8
|
SECONDARY outcome
Timeframe: up to 30 days after the last dose of study drug, up to 18 weeksPopulation: Safety analysis set: The safety set included all participants who received at least one dose of study medication.
Adverse event monitoring was conducted throughout the study.
Outcome measures
| Measure |
FGFR2 (MUT)
n=22 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
FGFR2 (WT)
n=31 Participants
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Adverse events (serious and non-serious)
|
22 Participants
|
31 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Serious adverse events
|
10 Participants
|
20 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Deaths
|
1 Participants
|
4 Participants
|
Adverse Events
FGFR2 (MUT)
Serious events: 10 serious events
Other events: 21 other events
Deaths: 0 deaths
FGFR2 (WT)
Serious events: 20 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FGFR2 (MUT)
n=22 participants at risk
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
FGFR2 (WT)
n=31 participants at risk
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/22
|
3.2%
1/31
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/22
|
3.2%
1/31
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/22
|
3.2%
1/31
|
|
Congenital, familial and genetic disorders
GASTROINTESTINAL ARTERIOVENOUS MALFORMATION
|
0.00%
0/22
|
3.2%
1/31
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/22
|
6.5%
2/31
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.5%
1/22
|
0.00%
0/31
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.00%
0/22
|
3.2%
1/31
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.5%
1/22
|
9.7%
3/31
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/22
|
3.2%
1/31
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/22
|
3.2%
1/31
|
|
Gastrointestinal disorders
NAUSEA
|
4.5%
1/22
|
6.5%
2/31
|
|
Gastrointestinal disorders
PANCREATIC DUCT DILATATION
|
0.00%
0/22
|
3.2%
1/31
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/22
|
9.7%
3/31
|
|
Gastrointestinal disorders
VOMITING
|
9.1%
2/22
|
16.1%
5/31
|
|
General disorders
FATIGUE
|
0.00%
0/22
|
3.2%
1/31
|
|
General disorders
LOCALISED OEDEMA
|
0.00%
0/22
|
3.2%
1/31
|
|
General disorders
MALAISE
|
0.00%
0/22
|
3.2%
1/31
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/22
|
6.5%
2/31
|
|
General disorders
PYREXIA
|
0.00%
0/22
|
6.5%
2/31
|
|
Hepatobiliary disorders
HEPATITIS TOXIC
|
4.5%
1/22
|
0.00%
0/31
|
|
Hepatobiliary disorders
JAUNDICE
|
4.5%
1/22
|
0.00%
0/31
|
|
Infections and infestations
SEPSIS
|
0.00%
0/22
|
3.2%
1/31
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/22
|
6.5%
2/31
|
|
Infections and infestations
UROSEPSIS
|
4.5%
1/22
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
GASTROENTERITIS RADIATION
|
0.00%
0/22
|
3.2%
1/31
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/22
|
3.2%
1/31
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/22
|
3.2%
1/31
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/22
|
3.2%
1/31
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/22
|
3.2%
1/31
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/22
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/22
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
4.5%
1/22
|
9.7%
3/31
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/22
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/22
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
4.5%
1/22
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
4.5%
1/22
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
4.5%
1/22
|
0.00%
0/31
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
4.5%
1/22
|
0.00%
0/31
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/22
|
3.2%
1/31
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/22
|
3.2%
1/31
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.00%
0/22
|
3.2%
1/31
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/22
|
3.2%
1/31
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
4.5%
1/22
|
0.00%
0/31
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
4.5%
1/22
|
0.00%
0/31
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/22
|
3.2%
1/31
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/22
|
6.5%
2/31
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/22
|
3.2%
1/31
|
|
Renal and urinary disorders
UROGENITAL FISTULA
|
0.00%
0/22
|
3.2%
1/31
|
|
Reproductive system and breast disorders
FEMALE GENITAL TRACT FISTULA
|
0.00%
0/22
|
6.5%
2/31
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
4.5%
1/22
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.00%
0/22
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/22
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/22
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
13.6%
3/22
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/22
|
3.2%
1/31
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.00%
0/22
|
3.2%
1/31
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
9.1%
2/22
|
0.00%
0/31
|
|
Vascular disorders
EMBOLISM
|
4.5%
1/22
|
6.5%
2/31
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/22
|
6.5%
2/31
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/22
|
6.5%
2/31
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/22
|
3.2%
1/31
|
|
Vascular disorders
PELVIC VENOUS THROMBOSIS
|
4.5%
1/22
|
0.00%
0/31
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
4.5%
1/22
|
0.00%
0/31
|
Other adverse events
| Measure |
FGFR2 (MUT)
n=22 participants at risk
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
FGFR2 (WT)
n=31 participants at risk
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
13.6%
3/22
|
32.3%
10/31
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/22
|
6.5%
2/31
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
4.5%
1/22
|
9.7%
3/31
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
4.5%
1/22
|
6.5%
2/31
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/22
|
12.9%
4/31
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/22
|
6.5%
2/31
|
|
Eye disorders
DRY EYE
|
9.1%
2/22
|
12.9%
4/31
|
|
Eye disorders
EYE DISCHARGE
|
0.00%
0/22
|
6.5%
2/31
|
|
Eye disorders
OCULAR HYPERAEMIA
|
0.00%
0/22
|
9.7%
3/31
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/22
|
6.5%
2/31
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
22.7%
5/22
|
19.4%
6/31
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
4.5%
1/22
|
6.5%
2/31
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/22
|
6.5%
2/31
|
|
Gastrointestinal disorders
CONSTIPATION
|
18.2%
4/22
|
19.4%
6/31
|
|
Gastrointestinal disorders
DIARRHOEA
|
63.6%
14/22
|
77.4%
24/31
|
|
Gastrointestinal disorders
DRY MOUTH
|
13.6%
3/22
|
9.7%
3/31
|
|
Gastrointestinal disorders
DYSPEPSIA
|
18.2%
4/22
|
16.1%
5/31
|
|
Gastrointestinal disorders
FLATULENCE
|
9.1%
2/22
|
12.9%
4/31
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
4.5%
1/22
|
6.5%
2/31
|
|
Gastrointestinal disorders
NAUSEA
|
72.7%
16/22
|
67.7%
21/31
|
|
Gastrointestinal disorders
STOMATITIS
|
4.5%
1/22
|
6.5%
2/31
|
|
Gastrointestinal disorders
VOMITING
|
63.6%
14/22
|
67.7%
21/31
|
|
General disorders
ASTHENIA
|
18.2%
4/22
|
16.1%
5/31
|
|
General disorders
FATIGUE
|
40.9%
9/22
|
51.6%
16/31
|
|
General disorders
LOCAL SWELLING
|
9.1%
2/22
|
0.00%
0/31
|
|
General disorders
OEDEMA PERIPHERAL
|
9.1%
2/22
|
12.9%
4/31
|
|
General disorders
PAIN
|
0.00%
0/22
|
19.4%
6/31
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/22
|
6.5%
2/31
|
|
Infections and infestations
URINARY TRACT INFECTION
|
13.6%
3/22
|
9.7%
3/31
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/22
|
6.5%
2/31
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/22
|
6.5%
2/31
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
18.2%
4/22
|
9.7%
3/31
|
|
Investigations
AMYLASE INCREASED
|
0.00%
0/22
|
6.5%
2/31
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
13.6%
3/22
|
6.5%
2/31
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
13.6%
3/22
|
25.8%
8/31
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
9.1%
2/22
|
0.00%
0/31
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
4.5%
1/22
|
9.7%
3/31
|
|
Investigations
BLOOD CREATININE INCREASED
|
13.6%
3/22
|
12.9%
4/31
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
9.1%
2/22
|
6.5%
2/31
|
|
Investigations
LIPASE INCREASED
|
9.1%
2/22
|
6.5%
2/31
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
4.5%
1/22
|
6.5%
2/31
|
|
Investigations
PLATELET COUNT DECREASED
|
4.5%
1/22
|
6.5%
2/31
|
|
Investigations
WEIGHT DECREASED
|
31.8%
7/22
|
16.1%
5/31
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
40.9%
9/22
|
29.0%
9/31
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
4.5%
1/22
|
16.1%
5/31
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
4.5%
1/22
|
12.9%
4/31
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
9.1%
2/22
|
16.1%
5/31
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
9.1%
2/22
|
29.0%
9/31
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
4.5%
1/22
|
16.1%
5/31
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/22
|
12.9%
4/31
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
18.2%
4/22
|
19.4%
6/31
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
4.5%
1/22
|
16.1%
5/31
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.5%
1/22
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
27.3%
6/22
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/22
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
4.5%
1/22
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/22
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/22
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
9.1%
2/22
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
27.3%
6/22
|
29.0%
9/31
|
|
Nervous system disorders
DIZZINESS
|
13.6%
3/22
|
22.6%
7/31
|
|
Nervous system disorders
DYSGEUSIA
|
9.1%
2/22
|
6.5%
2/31
|
|
Nervous system disorders
HEADACHE
|
22.7%
5/22
|
19.4%
6/31
|
|
Nervous system disorders
PARAESTHESIA
|
9.1%
2/22
|
0.00%
0/31
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/22
|
6.5%
2/31
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/22
|
6.5%
2/31
|
|
Psychiatric disorders
INSOMNIA
|
9.1%
2/22
|
6.5%
2/31
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/22
|
12.9%
4/31
|
|
Renal and urinary disorders
PROTEINURIA
|
4.5%
1/22
|
9.7%
3/31
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
4.5%
1/22
|
6.5%
2/31
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
13.6%
3/22
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
9.1%
2/22
|
19.4%
6/31
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
9.1%
2/22
|
22.6%
7/31
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/22
|
9.7%
3/31
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/22
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.00%
0/22
|
6.5%
2/31
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
4.5%
1/22
|
6.5%
2/31
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
9.1%
2/22
|
3.2%
1/31
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
18.2%
4/22
|
9.7%
3/31
|
|
Skin and subcutaneous tissue disorders
RASH
|
40.9%
9/22
|
35.5%
11/31
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
9.1%
2/22
|
0.00%
0/31
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
4.5%
1/22
|
6.5%
2/31
|
|
Vascular disorders
EMBOLISM
|
9.1%
2/22
|
3.2%
1/31
|
|
Vascular disorders
HYPERTENSION
|
18.2%
4/22
|
25.8%
8/31
|
|
Vascular disorders
HYPOTENSION
|
9.1%
2/22
|
6.5%
2/31
|
Additional Information
Study Director
Novartis
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER