Trial Outcomes & Findings for LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib (NCT NCT01685060)
NCT ID: NCT01685060
Last Updated: 2017-06-19
Results Overview
ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
COMPLETED
PHASE2
140 participants
6 cycles of 28 days up to 24 weeks
2017-06-19
Participant Flow
Approximately 137 patients were planned to be enrolled. A total of 140 patients were enrolled and treated with ceritinib.
Participant milestones
| Measure |
LDK378 750mg
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Overall Study
STARTED
|
140
|
|
Overall Study
Entered Post-treatment Efficacy f/u
|
7
|
|
Overall Study
Entered Survival Follow up
|
98
|
|
Overall Study
Discontinued From Study
|
35
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
140
|
Reasons for withdrawal
| Measure |
LDK378 750mg
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Overall Study
Rollover patients
|
16
|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Progressive disease
|
69
|
|
Overall Study
Physician Decision
|
14
|
|
Overall Study
Subject/guardian decision
|
20
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
8
|
Baseline Characteristics
LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib
Baseline characteristics by cohort
| Measure |
LDK378 750mg
n=140 Participants
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Age, Continuous
|
51.2 Years
STANDARD_DEVIATION 11.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 cycles of 28 days up to 24 weeksPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.
ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
LDK378 750mg
n=140 Participants
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Overall Response Rate (ORR) to LDK378 Per Investigator Assessment
|
40.7 Percentage of participants
Interval 32.5 to 49.3
|
SECONDARY outcome
Timeframe: 6 cycles of 28 days up to 24 weeksPopulation: The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.
ORR (CR+PR) by BIRC is calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by BIRC. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
LDK378 750mg
n=140 Participants
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
ORR Per Blinded Independent Review Committee (BIRC) Assessment
|
35.7 Percentage of participants
Interval 27.8 to 44.2
|
SECONDARY outcome
Timeframe: 6 cycles of 28 days up to 24 weeksPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) per Investigator were included in this analysis.
DOR, calculated as the time from the date of the first confirmed CR or PR to the first documented progression or death due to any cause, by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
LDK378 750mg
n=57 Participants
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Duration of Response (DOR) by Investigator
|
10.6 Months
Interval 7.4 to 14.7
|
SECONDARY outcome
Timeframe: 6 cycles of 28 days up to 24 weeksPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) per BIRC were included in this analysis.
DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer, by BIRC (Blinded Imaging Review Committee). CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
LDK378 750mg
n=50 Participants
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Duration of Response (DOR) by BIRC
|
12.9 Months
Interval 9.3 to 18.4
|
SECONDARY outcome
Timeframe: 6 cycles of 28 days up to 24 weeksPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.
DCR was calculated as the percentage of patients with best overall response of CR, PR, SD, or non-CR non-PD (NCRNPD), per RECIST 1.1 by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD (NCRNPD): refers to best overall responses that are neither CR nor PD per RECIST 1.1 criteria for patients with non-measurable disease only at baseline.
Outcome measures
| Measure |
LDK378 750mg
n=140 Participants
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Disease Control Rate (DCR)
DCR per Investigator
|
76.4 Percentage of participants
Interval 68.5 to 83.2
|
|
Disease Control Rate (DCR)
DCR per BIRC
|
80.0 Percentage of participants
Interval 72.4 to 86.3
|
SECONDARY outcome
Timeframe: 6 cycles of 28 days up to 24 weeksPopulation: The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) were included in this analysis.
TTR is the time from date of start of treatment to the first CR or PR observed which were confirmed afterwards.
Outcome measures
| Measure |
LDK378 750mg
n=57 Participants
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Time to Response (TTR) Per Investigator
|
3.0 Months
Standard Deviation 3.54 • Interval 1.6 to 18.7
|
SECONDARY outcome
Timeframe: 6 cycles of 28 days up to 24 weeksPopulation: The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) were included in this analysis.
TTR is the time from date of start of treatment to the first CR or PR observed which are confirmed afterwards.
Outcome measures
| Measure |
LDK378 750mg
n=50 Participants
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Time to Response (TTR) Per BIRC
|
2.2 Months
Standard Deviation 1.44 • Interval 1.6 to 10.9
|
SECONDARY outcome
Timeframe: 6 cycles of 28 days up to 24 weeksPopulation: The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.
PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.
Outcome measures
| Measure |
LDK378 750mg
n=140 Participants
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Progression-free Survival (PFS) Per Investigator
|
5.8 months
Interval 5.4 to 7.6
|
SECONDARY outcome
Timeframe: 6 cycles of 28 days up to 24 weeksPopulation: The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.
PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.
Outcome measures
| Measure |
LDK378 750mg
n=140 Participants
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Progression-free Survival (PFS) Per BIRC
|
7.4 months
Interval 5.6 to 10.9
|
SECONDARY outcome
Timeframe: 6 cycles of 28 days up to 24 weeksPopulation: The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with measurable disease in brain at baseline selected by Investigator were included in this analysis.
OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.
Outcome measures
| Measure |
LDK378 750mg
n=20 Participants
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Overall Intracranial Response Rate (OIRR) Per Investigator
|
45.0 Percentage of participants
Interval 23.1 to 68.5
|
SECONDARY outcome
Timeframe: 6 cycles of 28 days up to 24 weeksPopulation: The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with measurable disease in brain at baseline selected by BIRC were included in this analysis.
OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.
Outcome measures
| Measure |
LDK378 750mg
n=28 Participants
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Overall Intracranial Response Rate (OIRR) Per BIRC
|
35.7 Percentage of participants
Interval 18.6 to 55.9
|
SECONDARY outcome
Timeframe: 6 cycles of 28 days up to 24 weeksPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.
OS, defined as the time from date of randomization/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 known date patient alive.
Outcome measures
| Measure |
LDK378 750mg
n=140 Participants
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Overall Survival (OS)
|
15.6 Months
Interval 13.6 to 24.2
|
Adverse Events
LDK378 750 mg
Serious adverse events
| Measure |
LDK378 750 mg
n=140 participants at risk
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
PERICARDITIS
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.1%
3/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
ASCITES
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
FAECALOMA
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
GASTROINTESTINAL TOXICITY
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
NAUSEA
|
2.1%
3/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
PANCREATITIS
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
RETROPERITONEAL FIBROSIS
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
VOMITING
|
2.9%
4/140 • Timeframe for AE
AE additional description
|
|
General disorders
ASTHENIA
|
2.1%
3/140 • Timeframe for AE
AE additional description
|
|
General disorders
DISEASE PROGRESSION
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
General disorders
MALAISE
|
2.1%
3/140 • Timeframe for AE
AE additional description
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
2.1%
3/140 • Timeframe for AE
AE additional description
|
|
General disorders
PAIN
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
General disorders
PYREXIA
|
5.7%
8/140 • Timeframe for AE
AE additional description
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Hepatobiliary disorders
HEPATOCELLULAR INJURY
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Infections and infestations
EMPYEMA
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Infections and infestations
ENTERITIS INFECTIOUS
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Infections and infestations
LUNG INFECTION
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Infections and infestations
MENINGITIS
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Infections and infestations
PLEURAL INFECTION
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Infections and infestations
PNEUMONIA
|
4.3%
6/140 • Timeframe for AE
AE additional description
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Infections and infestations
SEPTIC SHOCK
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Infections and infestations
VIRAL PERICARDITIS
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
PUBIS FRACTURE
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Investigations
BLOOD CALCIUM INCREASED
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Investigations
BLOOD CREATININE INCREASED
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
Investigations
WEIGHT DECREASED
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.9%
4/140 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO MENINGES
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
APHASIA
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
BRAIN OEDEMA
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
DYSARTHRIA
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
HEADACHE
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
HYPERAESTHESIA
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
LETHARGY
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
MOTOR DYSFUNCTION
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
PARAESTHESIA
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
PARAPARESIS
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
SEIZURE
|
2.9%
4/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
SENSORY LOSS
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.0%
7/140 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.1%
3/140 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
2.1%
3/140 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.4%
2/140 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.71%
1/140 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
2.1%
3/140 • Timeframe for AE
AE additional description
|
Other adverse events
| Measure |
LDK378 750 mg
n=140 participants at risk
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
17.9%
25/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
32.1%
45/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
11.4%
16/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
CONSTIPATION
|
30.0%
42/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
DIARRHOEA
|
82.1%
115/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
NAUSEA
|
82.1%
115/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
STOMATITIS
|
7.9%
11/140 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
VOMITING
|
65.7%
92/140 • Timeframe for AE
AE additional description
|
|
General disorders
ASTHENIA
|
17.9%
25/140 • Timeframe for AE
AE additional description
|
|
General disorders
FATIGUE
|
38.6%
54/140 • Timeframe for AE
AE additional description
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
17.9%
25/140 • Timeframe for AE
AE additional description
|
|
General disorders
OEDEMA PERIPHERAL
|
13.6%
19/140 • Timeframe for AE
AE additional description
|
|
General disorders
PYREXIA
|
20.0%
28/140 • Timeframe for AE
AE additional description
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.4%
9/140 • Timeframe for AE
AE additional description
|
|
Infections and infestations
PNEUMONIA
|
6.4%
9/140 • Timeframe for AE
AE additional description
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
12.9%
18/140 • Timeframe for AE
AE additional description
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
46.4%
65/140 • Timeframe for AE
AE additional description
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
39.3%
55/140 • Timeframe for AE
AE additional description
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
16.4%
23/140 • Timeframe for AE
AE additional description
|
|
Investigations
BLOOD CREATININE INCREASED
|
19.3%
27/140 • Timeframe for AE
AE additional description
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
8.6%
12/140 • Timeframe for AE
AE additional description
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
18.6%
26/140 • Timeframe for AE
AE additional description
|
|
Investigations
WEIGHT DECREASED
|
34.3%
48/140 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
42.1%
59/140 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
5.7%
8/140 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
6.4%
9/140 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.4%
16/140 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
20.0%
28/140 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
6.4%
9/140 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
10.0%
14/140 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
7.1%
10/140 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
7.9%
11/140 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
10.0%
14/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
DIZZINESS
|
10.7%
15/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
DYSGEUSIA
|
8.6%
12/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
HEADACHE
|
22.1%
31/140 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
PARAESTHESIA
|
5.7%
8/140 • Timeframe for AE
AE additional description
|
|
Psychiatric disorders
ANXIETY
|
7.9%
11/140 • Timeframe for AE
AE additional description
|
|
Psychiatric disorders
INSOMNIA
|
12.9%
18/140 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
23.6%
33/140 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
20.7%
29/140 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
7.1%
10/140 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
6.4%
9/140 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
7.1%
10/140 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.7%
8/140 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
RASH
|
17.1%
24/140 • Timeframe for AE
AE additional description
|
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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER