Trial Outcomes & Findings for A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment (NCT NCT01232296)
NCT ID: NCT01232296
Last Updated: 2015-12-04
Results Overview
The overall survival (OS), defined as the time from date of randomization to the date of death from any cause. If a patient was not known to have died at the date of analysis cut-off, OS was censored at the last date of contact. Survival information was collected every 6 wks until at least 130 deaths have been observed
COMPLETED
PHASE2
162 participants
Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.
2015-12-04
Participant Flow
165 Participants were screened and randomized. However 3 participants discontinued prior to recieving study drug. The number enrolled in the protocol section reflects the randomized participants who received study drug.
Participant milestones
| Measure |
TKI258
500 mg capsules p.o. o.d. 5 days on/2 days off
|
Sorafenib
400 mg tablet p.o. b.i.d.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
83
|
|
Overall Study
Full Analysis Set
|
82
|
83
|
|
Overall Study
Safety Set
|
79
|
83
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
82
|
83
|
Reasons for withdrawal
| Measure |
TKI258
500 mg capsules p.o. o.d. 5 days on/2 days off
|
Sorafenib
400 mg tablet p.o. b.i.d.
|
|---|---|---|
|
Overall Study
Adverse Event
|
24
|
12
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Progressive disease
|
43
|
61
|
|
Overall Study
Study terminated by sponsor
|
0
|
1
|
|
Overall Study
Technical problems
|
3
|
0
|
|
Overall Study
Subject/guardian decision
|
10
|
2
|
|
Overall Study
Death
|
1
|
6
|
Baseline Characteristics
A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment
Baseline characteristics by cohort
| Measure |
TKI258
n=82 Participants
500 mg capsules p.o. o.d. 5 days on/2 days off
|
Sorafenib
n=83 Participants
400 mg tablet p.o. b.i.d.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 Years
STANDARD_DEVIATION 12.16 • n=5 Participants
|
56.2 Years
STANDARD_DEVIATION 11.72 • n=7 Participants
|
55.8 Years
STANDARD_DEVIATION 11.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.Population: The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.
The overall survival (OS), defined as the time from date of randomization to the date of death from any cause. If a patient was not known to have died at the date of analysis cut-off, OS was censored at the last date of contact. Survival information was collected every 6 wks until at least 130 deaths have been observed
Outcome measures
| Measure |
TKI258
n=82 Participants
500 mg capsules p.o. o.d. 5 days on/2 days off
|
Sorafenib
n=83 Participants
400 mg tablet p.o. b.i.d.
|
|---|---|---|
|
Overall Survival - Overall Survival
|
33 Weeks
Interval 25.7 to 39.0
|
39.4 Weeks
Interval 22.6 to 56.1
|
SECONDARY outcome
Timeframe: Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.Population: The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.
Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). For target lesions, disease progression mean at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression refers to unequivocal progression of existing non-target lesions. In addition, the appearance of new lesions is always considered as disease progression.
Outcome measures
| Measure |
TKI258
n=82 Participants
500 mg capsules p.o. o.d. 5 days on/2 days off
|
Sorafenib
n=83 Participants
400 mg tablet p.o. b.i.d.
|
|---|---|---|
|
Time to Tumor Progression (Tumor Assessment)
|
17.6 Weeks
Interval 12.3 to 18.4
|
17.9 Weeks
Interval 12.3 to 18.9
|
SECONDARY outcome
Timeframe: Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.Population: The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.
Disease Control Rate (DCR) is defined as the proportion of patients whose best overall response is either complete response \[CR\], partial response \[PR\] or stable disease \[SD\] according to RECIST 1.1.
Outcome measures
| Measure |
TKI258
n=82 Participants
500 mg capsules p.o. o.d. 5 days on/2 days off
|
Sorafenib
n=83 Participants
400 mg tablet p.o. b.i.d.
|
|---|---|---|
|
Disease Control Rate (Tumor Assessment)
Complete response (CR)
|
0 Participants
|
1 Participants
|
|
Disease Control Rate (Tumor Assessment)
Partial response (PR)
|
5 Participants
|
8 Participants
|
|
Disease Control Rate (Tumor Assessment)
Stable disease (SD)
|
42 Participants
|
44 Participants
|
|
Disease Control Rate (Tumor Assessment)
Progressive disease
|
17 Participants
|
22 Participants
|
|
Disease Control Rate (Tumor Assessment)
Unknown (UNK)
|
18 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came firstPopulation: The Full Analysis Set (FAS): all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure. Only Total number of definitive deterioration events included in the analysis
Time to definitive deterioration on ECOG PS scale (by at least one point) was defined as the time from the date of randomization to the date of definitive deterioration of the ECOG PS by at least one category of the score from baseline or to the date of death whichever occurred earlier. 0 is Fully active, able to carry on all pre-disease performance without restriction, 1 is Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work and 2 is ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
Outcome measures
| Measure |
TKI258
n=82 Participants
500 mg capsules p.o. o.d. 5 days on/2 days off
|
Sorafenib
n=83 Participants
400 mg tablet p.o. b.i.d.
|
|---|---|---|
|
Time to Definitive Deterioration in ECOG Performance Status (PS)
|
22.3 Weeks
Interval 12.6 to 34.0
|
21.3 Weeks
Interval 13.6 to
NA -The upper bound of the 95% CI is not estimable because of the high censoring proportion (43 censored patients out of 83 patients, or 51.8%).
|
SECONDARY outcome
Timeframe: Week 1 day 1, week 4 day 5Population: The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile
Cmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after a single dose administration (mass x volume - 1).
Outcome measures
| Measure |
TKI258
n=71 Participants
500 mg capsules p.o. o.d. 5 days on/2 days off
|
Sorafenib
400 mg tablet p.o. b.i.d.
|
|---|---|---|
|
Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258
Week 1 Day 1 (n=71)
|
326.25 (ng/mL)
Standard Deviation 100.405
|
—
|
|
Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258
Week 4 Day 5 (n=23)
|
364.04 (ng/mL)
Standard Deviation 131.973
|
—
|
SECONDARY outcome
Timeframe: Week 1 day 1, week 4 day 5Population: The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile
Tmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Tmax is the time to to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after a single dose administration (time)
Outcome measures
| Measure |
TKI258
n=71 Participants
500 mg capsules p.o. o.d. 5 days on/2 days off
|
Sorafenib
400 mg tablet p.o. b.i.d.
|
|---|---|---|
|
Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258
Week 1 Day 1(71)
|
6 hours
Full Range NA • Interval 3.0 to 24.0
|
—
|
|
Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258
Week 4 Day 5 (n=23)
|
5.9 hours
Full Range NA • Interval 0.0 to 6.1
|
—
|
SECONDARY outcome
Timeframe: Week 1 day 1, week 4 day 5Population: The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile
The mean AUC from time zero to the last measurable concentration sampling time (t last) (mass x time x volume-1)
Outcome measures
| Measure |
TKI258
n=71 Participants
500 mg capsules p.o. o.d. 5 days on/2 days off
|
Sorafenib
400 mg tablet p.o. b.i.d.
|
|---|---|---|
|
Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258
Week 1 Day 1
|
5774.69 (ng.h/mL)
Standard Deviation 1616.159
|
—
|
|
Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258
Week 4 Day 5 (n=23)
|
6493.99 (ng.h/mL)
Standard Deviation 2409.119
|
—
|
Adverse Events
TKI258
Sorafenib
Serious adverse events
| Measure |
TKI258
n=79 participants at risk
500 mg capsules p.o. o.d. 5 days on/2 days off
|
Sorafenib
n=83 participants at risk
400 mg tablet p.o. b.i.d.
|
|---|---|---|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
1.3%
1/79
|
0.00%
0/83
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
2.5%
2/79
|
0.00%
0/83
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
1.3%
1/79
|
0.00%
0/83
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/79
|
1.2%
1/83
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.3%
1/79
|
0.00%
0/83
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/79
|
1.2%
1/83
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
1.3%
1/79
|
1.2%
1/83
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.3%
1/79
|
1.2%
1/83
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/79
|
2.4%
2/83
|
|
Gastrointestinal disorders
ASCITES
|
1.3%
1/79
|
2.4%
2/83
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.3%
1/79
|
0.00%
0/83
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.3%
1/79
|
1.2%
1/83
|
|
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
|
0.00%
0/79
|
1.2%
1/83
|
|
Gastrointestinal disorders
FLATULENCE
|
1.3%
1/79
|
0.00%
0/83
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
2.5%
2/79
|
3.6%
3/83
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/79
|
1.2%
1/83
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
2.5%
2/79
|
0.00%
0/83
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/79
|
2.4%
2/83
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
1.3%
1/79
|
0.00%
0/83
|
|
Gastrointestinal disorders
NAUSEA
|
2.5%
2/79
|
0.00%
0/83
|
|
Gastrointestinal disorders
OESOPHAGEAL ULCER
|
0.00%
0/79
|
1.2%
1/83
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
1.3%
1/79
|
1.2%
1/83
|
|
Gastrointestinal disorders
PERITONEAL HAEMORRHAGE
|
0.00%
0/79
|
2.4%
2/83
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
2.5%
2/79
|
2.4%
2/83
|
|
Gastrointestinal disorders
VOMITING
|
2.5%
2/79
|
1.2%
1/83
|
|
General disorders
FATIGUE
|
3.8%
3/79
|
1.2%
1/83
|
|
General disorders
OEDEMA PERIPHERAL
|
2.5%
2/79
|
0.00%
0/83
|
|
General disorders
PYREXIA
|
12.7%
10/79
|
6.0%
5/83
|
|
Hepatobiliary disorders
ACUTE HEPATIC FAILURE
|
0.00%
0/79
|
1.2%
1/83
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
1.3%
1/79
|
0.00%
0/83
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
1.3%
1/79
|
0.00%
0/83
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/79
|
1.2%
1/83
|
|
Hepatobiliary disorders
JAUNDICE
|
1.3%
1/79
|
0.00%
0/83
|
|
Infections and infestations
CELLULITIS
|
1.3%
1/79
|
0.00%
0/83
|
|
Infections and infestations
DIARRHOEA INFECTIOUS
|
1.3%
1/79
|
0.00%
0/83
|
|
Infections and infestations
LIVER ABSCESS
|
0.00%
0/79
|
1.2%
1/83
|
|
Infections and infestations
PERITONITIS BACTERIAL
|
0.00%
0/79
|
2.4%
2/83
|
|
Infections and infestations
SEPSIS
|
1.3%
1/79
|
2.4%
2/83
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/79
|
1.2%
1/83
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.3%
1/79
|
1.2%
1/83
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMORRHAGE
|
1.3%
1/79
|
0.00%
0/83
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
1.3%
1/79
|
0.00%
0/83
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
1.3%
1/79
|
1.2%
1/83
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
3.8%
3/79
|
0.00%
0/83
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
3.8%
3/79
|
2.4%
2/83
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.3%
1/79
|
0.00%
0/83
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
1.3%
1/79
|
0.00%
0/83
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.3%
1/79
|
0.00%
0/83
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
1.3%
1/79
|
0.00%
0/83
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/79
|
1.2%
1/83
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATOCELLULAR CARCINOMA
|
0.00%
0/79
|
1.2%
1/83
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INFECTED NEOPLASM
|
0.00%
0/79
|
1.2%
1/83
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIVER CARCINOMA RUPTURED
|
0.00%
0/79
|
2.4%
2/83
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
1.3%
1/79
|
1.2%
1/83
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO SPINE
|
0.00%
0/79
|
1.2%
1/83
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
0.00%
0/79
|
1.2%
1/83
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/79
|
1.2%
1/83
|
|
Nervous system disorders
CONVULSION
|
0.00%
0/79
|
1.2%
1/83
|
|
Nervous system disorders
DIZZINESS
|
1.3%
1/79
|
0.00%
0/83
|
|
Nervous system disorders
ENCEPHALOPATHY
|
2.5%
2/79
|
0.00%
0/83
|
|
Nervous system disorders
HEADACHE
|
1.3%
1/79
|
0.00%
0/83
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
3.8%
3/79
|
2.4%
2/83
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/79
|
1.2%
1/83
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/79
|
1.2%
1/83
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
1.3%
1/79
|
0.00%
0/83
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/79
|
1.2%
1/83
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/79
|
1.2%
1/83
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.3%
1/79
|
0.00%
0/83
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/79
|
1.2%
1/83
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
1.3%
1/79
|
0.00%
0/83
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/79
|
1.2%
1/83
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
1.3%
1/79
|
0.00%
0/83
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.5%
2/79
|
2.4%
2/83
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
1.3%
1/79
|
0.00%
0/83
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.3%
1/79
|
1.2%
1/83
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/79
|
1.2%
1/83
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
1.3%
1/79
|
0.00%
0/83
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/79
|
1.2%
1/83
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
2.5%
2/79
|
0.00%
0/83
|
|
Skin and subcutaneous tissue disorders
TOXIC EPIDERMAL NECROLYSIS
|
1.3%
1/79
|
0.00%
0/83
|
|
Vascular disorders
AORTIC DISSECTION RUPTURE
|
1.3%
1/79
|
0.00%
0/83
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.3%
1/79
|
1.2%
1/83
|
|
Vascular disorders
HYPERTENSION
|
1.3%
1/79
|
0.00%
0/83
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/79
|
1.2%
1/83
|
Other adverse events
| Measure |
TKI258
n=79 participants at risk
500 mg capsules p.o. o.d. 5 days on/2 days off
|
Sorafenib
n=83 participants at risk
400 mg tablet p.o. b.i.d.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
12.7%
10/79
|
8.4%
7/83
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
5.1%
4/79
|
0.00%
0/83
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
10.1%
8/79
|
2.4%
2/83
|
|
Ear and labyrinth disorders
TINNITUS
|
6.3%
5/79
|
0.00%
0/83
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
8.9%
7/79
|
9.6%
8/83
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
15.2%
12/79
|
19.3%
16/83
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
16.5%
13/79
|
13.3%
11/83
|
|
Gastrointestinal disorders
ASCITES
|
12.7%
10/79
|
8.4%
7/83
|
|
Gastrointestinal disorders
CHEILITIS
|
5.1%
4/79
|
0.00%
0/83
|
|
Gastrointestinal disorders
CONSTIPATION
|
20.3%
16/79
|
14.5%
12/83
|
|
Gastrointestinal disorders
DIARRHOEA
|
60.8%
48/79
|
42.2%
35/83
|
|
Gastrointestinal disorders
DRY MOUTH
|
3.8%
3/79
|
6.0%
5/83
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
5.1%
4/79
|
1.2%
1/83
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
5.1%
4/79
|
1.2%
1/83
|
|
Gastrointestinal disorders
NAUSEA
|
40.5%
32/79
|
19.3%
16/83
|
|
Gastrointestinal disorders
STOMATITIS
|
16.5%
13/79
|
13.3%
11/83
|
|
Gastrointestinal disorders
VOMITING
|
39.2%
31/79
|
12.0%
10/83
|
|
General disorders
FATIGUE
|
34.2%
27/79
|
15.7%
13/83
|
|
General disorders
MALAISE
|
6.3%
5/79
|
6.0%
5/83
|
|
General disorders
OEDEMA PERIPHERAL
|
16.5%
13/79
|
13.3%
11/83
|
|
General disorders
PYREXIA
|
20.3%
16/79
|
21.7%
18/83
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
7.6%
6/79
|
8.4%
7/83
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.6%
6/79
|
3.6%
3/83
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
21.5%
17/79
|
20.5%
17/83
|
|
Investigations
AMMONIA INCREASED
|
5.1%
4/79
|
2.4%
2/83
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
29.1%
23/79
|
25.3%
21/83
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
7.6%
6/79
|
3.6%
3/83
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
25.3%
20/79
|
22.9%
19/83
|
|
Investigations
BLOOD CREATININE INCREASED
|
6.3%
5/79
|
2.4%
2/83
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
8.9%
7/79
|
4.8%
4/83
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
15.2%
12/79
|
2.4%
2/83
|
|
Investigations
PLATELET COUNT DECREASED
|
17.7%
14/79
|
9.6%
8/83
|
|
Investigations
WEIGHT DECREASED
|
24.1%
19/79
|
20.5%
17/83
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
8.9%
7/79
|
4.8%
4/83
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
39.2%
31/79
|
28.9%
24/83
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
3.8%
3/79
|
6.0%
5/83
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
12.7%
10/79
|
7.2%
6/83
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.6%
6/79
|
6.0%
5/83
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
5.1%
4/79
|
2.4%
2/83
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.3%
5/79
|
2.4%
2/83
|
|
Nervous system disorders
DIZZINESS
|
11.4%
9/79
|
2.4%
2/83
|
|
Nervous system disorders
HEADACHE
|
13.9%
11/79
|
4.8%
4/83
|
|
Psychiatric disorders
INSOMNIA
|
21.5%
17/79
|
10.8%
9/83
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.5%
13/79
|
9.6%
8/83
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
8.9%
7/79
|
6.0%
5/83
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
11.4%
9/79
|
9.6%
8/83
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
6.3%
5/79
|
1.2%
1/83
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.1%
4/79
|
4.8%
4/83
|
|
Skin and subcutaneous tissue disorders
ACNE
|
11.4%
9/79
|
0.00%
0/83
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
1.3%
1/79
|
22.9%
19/83
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
8.9%
7/79
|
0.00%
0/83
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
5.1%
4/79
|
2.4%
2/83
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
13.9%
11/79
|
66.3%
55/83
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.1%
8/79
|
6.0%
5/83
|
|
Skin and subcutaneous tissue disorders
RASH
|
34.2%
27/79
|
21.7%
18/83
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
5.1%
4/79
|
0.00%
0/83
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
5.1%
4/79
|
0.00%
0/83
|
|
Vascular disorders
HYPERTENSION
|
21.5%
17/79
|
24.1%
20/83
|
Additional Information
Study Director
Novartis Pharmaceuticals
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