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A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy.

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ClinicalTrials.gov Identifier: NCT01124864
Recruitment Status : Completed
First Posted : May 17, 2010
Results First Posted : March 2, 2016
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small-cell Lung Cancer
Intervention Drug: AUY922
Enrollment 153
Recruitment Details Two patients who were ongoing at the data cut-off of 30-Jul-2013 are considered as 'completed' in this study.
Pre-assignment Details  
Arm/Group Title Kras Mutant Patients EGFR Mutant Patients EGFR and Kras Wild Type Patients Patients With EML4-ALK Translocation Modified EGFR Mutant Patients
Hide Arm/Group Description Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions. Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions. Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions. Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions. The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions. For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
Period Title: Overall Study
Started 28 35 34 22 31 3
Completed 0 0 0 1 [1] 1 [1] 0
Not Completed 28 35 34 21 30 3
Reason Not Completed
Follow up phase competed as per protocol             18             22             24             18             26             2
Death             6             9             6             2             1             0
Withdrawal by Subject             2             3             4             0             2             1
Lost to Follow-up             1             1             0             1             0             0
Protocol Violation             1             0             0             0             1             0
[1]
1 patient ongoing at time of data cut-off 30-Jul-2013
Arm/Group Title Kras Mutant Patients EGFR Mutant Patients EGFR and Kras Wild Type Patients Patients With EML4-ALK Translocation Modified EGFR Mutant Patients Unknown Total
Hide Arm/Group Description Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions. Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions. Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions. Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions. The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions. For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions. Total of all reporting groups
Overall Number of Baseline Participants 28 35 34 22 31 3 153
Hide Baseline Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 28 participants 35 participants 34 participants 22 participants 31 participants 3 participants 153 participants
< 65 years 20 21 23 18 25 1 108
>= 65 years 8 14 11 4 6 2 45
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 35 participants 34 participants 22 participants 31 participants 3 participants 153 participants
Female
11
  39.3%
25
  71.4%
18
  52.9%
15
  68.2%
19
  61.3%
0
   0.0%
88
  57.5%
Male
17
  60.7%
10
  28.6%
16
  47.1%
7
  31.8%
12
  38.7%
3
 100.0%
65
  42.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 28 participants 35 participants 34 participants 22 participants 31 participants 3 participants 153 participants
Caucasian 25 25 23 16 16 2 107
Black 0 0 1 0 0 0 1
Asian 2 10 9 6 13 1 41
Other 1 0 1 0 2 0 4
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 28 participants 35 participants 34 participants 22 participants 31 participants 3 participants 153 participants
170.5  (9.94) 163.0  (6.63) 165.8  (10.32) 164.9  (9.80) 163.9  (8.93) 173.0  (14.73) 165.7  (9.49)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 28 participants 35 participants 34 participants 22 participants 31 participants 3 participants 153 participants
74.5  (16.22) 64.0  (12.05) 68.4  (13.49) 60.5  (12.30) 67.1  (11.02) 76.6  (15.75) 67.3  (13.70)
Weight category  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 28 participants 35 participants 34 participants 22 participants 31 participants 3 participants 153 participants
< 55 kg 4 10 4 10 4 0 32
55 - <75 kg 13 19 21 9 20 2 84
>= 75 kg 11 6 9 3 7 1 37
Body surface area  
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 28 participants 35 participants 34 participants 22 participants 31 participants 3 participants 153 participants
1.9  (0.23) 1.7  (0.18) 1.8  (0.21) 1.7  (0.20) 1.8  (0.18) 1.9  (0.27) 1.8  (0.21)
Percentage of LVEF (left ventricular ejection fraction)  
Mean (Standard Deviation)
Unit of measure:  Percentage of LVEF
Number Analyzed 28 participants 35 participants 34 participants 22 participants 31 participants 3 participants 153 participants
63.2  (8.92) 66.9  (7.63) 66.2  (9.27) 69.5  (8.68) 65.4  (7.64) 69.0  (10.54) 66.2  (8.51)
WHO Performance status   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 28 participants 35 participants 34 participants 22 participants 31 participants 3 participants 153 participants
Who Performance status: 0 10 13 10 9 11 1 54
Who Performance status: 1 18 19 21 11 20 2 91
Who Performance status: 2 0 3 3 2 0 0 8
[1]
Measure Description:

Who Performance status:

0: Fully active, able to carry on all pre-disease performance without restriction

  1. 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
  2. Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours
Smoking status  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 28 participants 35 participants 34 participants 22 participants 31 participants 3 participants 153 participants
Current smoker 3 1 2 2 1 1 10
Ex-smoker 21 12 18 5 16 0 72
Never smoked 4 22 14 15 14 2 71
Time since smoking cessation  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 28 participants 35 participants 34 participants 22 participants 31 participants 3 participants 153 participants
59.0  (80.65) 176.6  (15.04) 180.3  (120.88) NA [1]   (NA) 340.4  (179.18) NA [1]   (NA) 152.4  (142.22)
[1]
No patients were analyzed in this group.
1.Primary Outcome
Title Response Assessment by Study Stratum - Per Investigator Assessment
Hide Description The primary endpoint of the study was the investigator assessment of efficacy at 18 weeks in terms of response complete response (CR)/partial response (PR), stable disease (SD), or non clinical benefit (NCB) as assessed by response evaluation criteriain solid tumors (RECIST) version 1.0. ORR = patients with confirmed complete or partial response. Stable disease at 18 weeks = patients without response and with no assessment of progressive disease up to 18 weeks, but with an assessment of stable disease or better either within 2 weeks prior to the 18 week time point, or at the next non-missing assessment after the 18 week time point. No clinical benefit = all other patients.
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.
Arm/Group Title Kras Mutant Patients EGFR Mutant Patients EGFR and Kras Wild Type Patients Patients With EML4-ALK Translocation Modified EGFR Mutant Patients Unknown
Hide Arm/Group Description:
Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
Overall Number of Participants Analyzed 28 35 34 22 31 3
Measure Type: Number
Unit of Measure: Participants
Overall respose rate (ORR) 0 6 3 7 3 1
Stable disease for ≥18 weeks 2 3 3 2 7 0
No clinical benefit 26 26 28 13 21 2
2.Secondary Outcome
Title Overall Survival Rate Using Kaplan Meier Estimates - Per Investigator Radiological Review
Hide Description Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact.
Time Frame Week 12, Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.
Arm/Group Title Kras Mutant Patients EGFR Mutant Patients EGFR and Kras Wild Type Patients Patients With EML4-ALK Translocation Modified EGFR Mutant Patients Unknown
Hide Arm/Group Description:
Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
Overall Number of Participants Analyzed 28 35 34 22 31 3
Measure Type: Number
Unit of Measure: Percentage of participants
12 weeks 68.7 77.0 78.6 90.7 96.7 66.7
18 weeks 55.9 74.1 72.3 71.6 93.3 33.3
3.Secondary Outcome
Title Progression Free Survival (PFS) Rate as Per Investigator Using Kaplan Meier Estimates - Per Investigator Radiological Review
Hide Description Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment. A Novartis modified response evaluation criteria in solid tumors RECIST 1.1 criteria was applied to CT/MRI imaging data when assessing any responses to AUY922 treatment. All images were evaluated locally by the investigator. All complete or partial responses were confirmed by a second assessment at least 4 weeks later.
Time Frame Week 12, Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.
Arm/Group Title Kras Mutant Patients EGFR Mutant Patients EGFR and Kras Wild Type Patients Patients With EML4-ALK Translocation Modified EGFR Mutant Patients Unknown
Hide Arm/Group Description:
Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
Overall Number of Participants Analyzed 28 35 34 22 31 3
Measure Type: Number
Unit of Measure: Percentage of participants
12 weeks 31.5 44.4 31.5 45.5 56.4 33.3
18 weeks 9.0 27.7 24.0 36.4 37.8 33.3
4.Secondary Outcome
Title Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUCinf
Hide Description Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for area under the curve infinity. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.
Time Frame 1 hour after infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.
Arm/Group Title AUY922 BJP762
Hide Arm/Group Description:
AUY922 Plasma Concentration
AUY Metabolite
Overall Number of Participants Analyzed 119 117
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
2101.27  (990.320) 13963.07  (13006.537)
5.Secondary Outcome
Title Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUClast
Hide Description Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for area under the curve last. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.
Time Frame 1 hour after infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.
Arm/Group Title AUY922 BJP762
Hide Arm/Group Description:
AUY922 Plasma Concentration
AUY Metabolite
Overall Number of Participants Analyzed 139 142
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1997.04  (894.903) 12496.75  (12035.525)
6.Secondary Outcome
Title Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: Cmax
Hide Description Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for concentration max. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.
Time Frame 1 hour after infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.
Arm/Group Title AUY922 BJP762
Hide Arm/Group Description:
AUY922 Plasma Concentration
AUY Metabolite
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: ng/mL
1130.59  (705.177) 2332.86  (1377.350)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title KRAS Mutant EGFR Mutant KRAS and EGFR Wild Type EML4-ALK Translocation Modified EGFR Mutant [Not Specified]
Hide Arm/Group Description Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions. Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions. Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions. Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions. The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI.Patients received AUY922 at 70 mg/m^2 weekly infusions. For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
All-Cause Mortality
KRAS Mutant EGFR Mutant KRAS and EGFR Wild Type EML4-ALK Translocation Modified EGFR Mutant [Not Specified]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
KRAS Mutant EGFR Mutant KRAS and EGFR Wild Type EML4-ALK Translocation Modified EGFR Mutant [Not Specified]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/28 (60.71%)   18/35 (51.43%)   22/34 (64.71%)   6/22 (27.27%)   11/31 (35.48%)   2/3 (66.67%) 
Blood and lymphatic system disorders             
Anaemia † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Cardiac disorders             
Atrial Fibrillation † 1  0/28 (0.00%)  1/35 (2.86%)  2/34 (5.88%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Bundle Branch Block Right † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Cardio-Respiratory Arrest † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Palpitations † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Pericardial Effusion † 1  0/28 (0.00%)  1/35 (2.86%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Supraventricular Tachycardia † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Tachycardia † 1  0/28 (0.00%)  1/35 (2.86%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Eye disorders             
Night Blindness † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders             
Abdominal Distension † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  1/3 (33.33%) 
Diarrhoea † 1  1/28 (3.57%)  3/35 (8.57%)  1/34 (2.94%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Proctalgia † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Rectal Fissure † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Vomiting † 1  1/28 (3.57%)  1/35 (2.86%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
General disorders             
Asthenia † 1  0/28 (0.00%)  1/35 (2.86%)  2/34 (5.88%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Fatigue † 1  0/28 (0.00%)  0/35 (0.00%)  2/34 (5.88%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
General Physical Health Deterioration † 1  1/28 (3.57%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Mucosal Inflammation † 1  0/28 (0.00%)  1/35 (2.86%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Oedema Peripheral † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Pain † 1  1/28 (3.57%)  2/35 (5.71%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Pyrexia † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Hepatobiliary disorders             
Cholelithiasis † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Hyperbilirubinaemia † 1  0/28 (0.00%)  1/35 (2.86%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Infections and infestations             
Atypical Pneumonia † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  1/22 (4.55%)  0/31 (0.00%)  0/3 (0.00%) 
Bronchitis † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Klebsiella Infection † 1  0/28 (0.00%)  1/35 (2.86%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Lung Infection † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  1/22 (4.55%)  0/31 (0.00%)  0/3 (0.00%) 
Perirectal Abscess † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Pneumonia † 1  3/28 (10.71%)  1/35 (2.86%)  1/34 (2.94%)  1/22 (4.55%)  0/31 (0.00%)  1/3 (33.33%) 
Respiratory Tract Infection † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  1/22 (4.55%)  0/31 (0.00%)  0/3 (0.00%) 
Urinary Tract Infection † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Metabolism and nutrition disorders             
Decreased Appetite † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Dehydration † 1  1/28 (3.57%)  1/35 (2.86%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Failure To Thrive † 1  1/28 (3.57%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Fluid Intake Reduced † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Hypercalcaemia † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Hyperglycaemia † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Hyperkalaemia † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Hyponatraemia † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders             
Bone Pain † 1  1/28 (3.57%)  1/35 (2.86%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Musculoskeletal Pain † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Neck Pain † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Metastases To Central Nervous System † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Metastatic Pain † 1  0/28 (0.00%)  1/35 (2.86%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Nervous system disorders             
Balance Disorder † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Brain Compression † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Nervous System Disorder † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Spinal Cord Compression † 1  0/28 (0.00%)  1/35 (2.86%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Vocal Cord Paresis † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Psychiatric disorders             
Confusional State † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Depression † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Acute Respiratory Failure † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  1/22 (4.55%)  0/31 (0.00%)  0/3 (0.00%) 
Dyspnoea † 1  3/28 (10.71%)  2/35 (5.71%)  2/34 (5.88%)  3/22 (13.64%)  0/31 (0.00%)  0/3 (0.00%) 
Haemoptysis † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  1/22 (4.55%)  0/31 (0.00%)  0/3 (0.00%) 
Hypoxia † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Pleural Effusion † 1  0/28 (0.00%)  1/35 (2.86%)  1/34 (2.94%)  0/22 (0.00%)  4/31 (12.90%)  0/3 (0.00%) 
Pneumothorax † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Pulmonary Embolism † 1  1/28 (3.57%)  3/35 (8.57%)  1/34 (2.94%)  1/22 (4.55%)  0/31 (0.00%)  0/3 (0.00%) 
Respiratory Failure † 1  0/28 (0.00%)  2/35 (5.71%)  0/34 (0.00%)  1/22 (4.55%)  0/31 (0.00%)  0/3 (0.00%) 
Vascular disorders             
Deep Vein Thrombosis † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Hypertension † 1  0/28 (0.00%)  2/35 (5.71%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Thrombosis † 1  1/28 (3.57%)  1/35 (2.86%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
KRAS Mutant EGFR Mutant KRAS and EGFR Wild Type EML4-ALK Translocation Modified EGFR Mutant [Not Specified]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/28 (100.00%)   35/35 (100.00%)   33/34 (97.06%)   22/22 (100.00%)   31/31 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders             
Anaemia † 1  1/28 (3.57%)  3/35 (8.57%)  5/34 (14.71%)  3/22 (13.64%)  4/31 (12.90%)  0/3 (0.00%) 
Lymphadenopathy † 1  0/28 (0.00%)  0/35 (0.00%)  2/34 (5.88%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Lymphopenia † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  2/31 (6.45%)  0/3 (0.00%) 
Cardiac disorders             
Tachycardia † 1  0/28 (0.00%)  2/35 (5.71%)  1/34 (2.94%)  1/22 (4.55%)  0/31 (0.00%)  0/3 (0.00%) 
Ear and labyrinth disorders             
Ear Pain † 1  0/28 (0.00%)  1/35 (2.86%)  2/34 (5.88%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Vertigo † 1  0/28 (0.00%)  1/35 (2.86%)  2/34 (5.88%)  2/22 (9.09%)  1/31 (3.23%)  0/3 (0.00%) 
Eye disorders             
Accommodation Disorder † 1  1/28 (3.57%)  2/35 (5.71%)  2/34 (5.88%)  2/22 (9.09%)  5/31 (16.13%)  0/3 (0.00%) 
Blepharitis † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  2/31 (6.45%)  0/3 (0.00%) 
Cataract Subcapsular † 1  1/28 (3.57%)  0/35 (0.00%)  2/34 (5.88%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Colour Blindness Acquired † 1  0/28 (0.00%)  3/35 (8.57%)  2/34 (5.88%)  5/22 (22.73%)  4/31 (12.90%)  1/3 (33.33%) 
Dry Eye † 1  2/28 (7.14%)  0/35 (0.00%)  1/34 (2.94%)  2/22 (9.09%)  0/31 (0.00%)  0/3 (0.00%) 
Eye Pain † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  2/31 (6.45%)  0/3 (0.00%) 
Lacrimation Increased † 1  0/28 (0.00%)  2/35 (5.71%)  0/34 (0.00%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Loss Of Visual Contrast Sensitivity † 1  0/28 (0.00%)  0/35 (0.00%)  2/34 (5.88%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Night Blindness † 1  3/28 (10.71%)  10/35 (28.57%)  6/34 (17.65%)  5/22 (22.73%)  10/31 (32.26%)  1/3 (33.33%) 
Ocular Toxicity † 1  4/28 (14.29%)  4/35 (11.43%)  1/34 (2.94%)  3/22 (13.64%)  3/31 (9.68%)  1/3 (33.33%) 
Photophobia † 1  3/28 (10.71%)  2/35 (5.71%)  5/34 (14.71%)  0/22 (0.00%)  2/31 (6.45%)  0/3 (0.00%) 
Photopsia † 1  3/28 (10.71%)  5/35 (14.29%)  10/34 (29.41%)  10/22 (45.45%)  6/31 (19.35%)  0/3 (0.00%) 
Retinal Disorder † 1  1/28 (3.57%)  3/35 (8.57%)  1/34 (2.94%)  5/22 (22.73%)  7/31 (22.58%)  0/3 (0.00%) 
Vision Blurred † 1  5/28 (17.86%)  6/35 (17.14%)  7/34 (20.59%)  6/22 (27.27%)  6/31 (19.35%)  0/3 (0.00%) 
Visual Acuity Reduced † 1  1/28 (3.57%)  6/35 (17.14%)  7/34 (20.59%)  7/22 (31.82%)  5/31 (16.13%)  0/3 (0.00%) 
Visual Impairment † 1  6/28 (21.43%)  8/35 (22.86%)  3/34 (8.82%)  6/22 (27.27%)  7/31 (22.58%)  0/3 (0.00%) 
Vitreous Floaters † 1  1/28 (3.57%)  3/35 (8.57%)  1/34 (2.94%)  1/22 (4.55%)  2/31 (6.45%)  1/3 (33.33%) 
Gastrointestinal disorders             
Abdominal Distension † 1  0/28 (0.00%)  0/35 (0.00%)  2/34 (5.88%)  2/22 (9.09%)  0/31 (0.00%)  1/3 (33.33%) 
Abdominal Pain † 1  5/28 (17.86%)  5/35 (14.29%)  4/34 (11.76%)  6/22 (27.27%)  2/31 (6.45%)  0/3 (0.00%) 
Abdominal Pain Upper † 1  1/28 (3.57%)  3/35 (8.57%)  2/34 (5.88%)  0/22 (0.00%)  2/31 (6.45%)  0/3 (0.00%) 
Constipation † 1  6/28 (21.43%)  6/35 (17.14%)  5/34 (14.71%)  5/22 (22.73%)  5/31 (16.13%)  0/3 (0.00%) 
Diarrhoea † 1  25/28 (89.29%)  23/35 (65.71%)  25/34 (73.53%)  17/22 (77.27%)  24/31 (77.42%)  3/3 (100.00%) 
Dry Mouth † 1  5/28 (17.86%)  4/35 (11.43%)  6/34 (17.65%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Dyspepsia † 1  0/28 (0.00%)  1/35 (2.86%)  1/34 (2.94%)  4/22 (18.18%)  3/31 (9.68%)  1/3 (33.33%) 
Flatulence † 1  0/28 (0.00%)  2/35 (5.71%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Nausea † 1  16/28 (57.14%)  19/35 (54.29%)  13/34 (38.24%)  11/22 (50.00%)  12/31 (38.71%)  1/3 (33.33%) 
Oral Pain † 1  0/28 (0.00%)  2/35 (5.71%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Rectal Haemorrhage † 1  2/28 (7.14%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Stomatitis † 1  1/28 (3.57%)  0/35 (0.00%)  2/34 (5.88%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Vomiting † 1  13/28 (46.43%)  13/35 (37.14%)  4/34 (11.76%)  9/22 (40.91%)  4/31 (12.90%)  2/3 (66.67%) 
General disorders             
Asthenia † 1  13/28 (46.43%)  14/35 (40.00%)  10/34 (29.41%)  10/22 (45.45%)  5/31 (16.13%)  1/3 (33.33%) 
Catheter Site Pain † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  2/31 (6.45%)  0/3 (0.00%) 
Chest Pain † 1  1/28 (3.57%)  2/35 (5.71%)  0/34 (0.00%)  4/22 (18.18%)  0/31 (0.00%)  1/3 (33.33%) 
Fatigue † 1  7/28 (25.00%)  9/35 (25.71%)  13/34 (38.24%)  3/22 (13.64%)  15/31 (48.39%)  0/3 (0.00%) 
Gait Disturbance † 1  0/28 (0.00%)  2/35 (5.71%)  2/34 (5.88%)  2/22 (9.09%)  0/31 (0.00%)  0/3 (0.00%) 
Non-Cardiac Chest Pain † 1  1/28 (3.57%)  0/35 (0.00%)  2/34 (5.88%)  2/22 (9.09%)  1/31 (3.23%)  0/3 (0.00%) 
Oedema Peripheral † 1  2/28 (7.14%)  2/35 (5.71%)  1/34 (2.94%)  3/22 (13.64%)  3/31 (9.68%)  0/3 (0.00%) 
Pain † 1  1/28 (3.57%)  2/35 (5.71%)  6/34 (17.65%)  0/22 (0.00%)  1/31 (3.23%)  1/3 (33.33%) 
Pyrexia † 1  5/28 (17.86%)  3/35 (8.57%)  4/34 (11.76%)  6/22 (27.27%)  4/31 (12.90%)  2/3 (66.67%) 
Infections and infestations             
Conjunctivitis † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  2/22 (9.09%)  1/31 (3.23%)  0/3 (0.00%) 
Influenza † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  3/31 (9.68%)  0/3 (0.00%) 
Nasopharyngitis † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  1/22 (4.55%)  4/31 (12.90%)  1/3 (33.33%) 
Respiratory Tract Infection † 1  0/28 (0.00%)  0/35 (0.00%)  2/34 (5.88%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Upper Respiratory Tract Infection † 1  0/28 (0.00%)  2/35 (5.71%)  1/34 (2.94%)  2/22 (9.09%)  4/31 (12.90%)  0/3 (0.00%) 
Urinary Tract Infection † 1  1/28 (3.57%)  2/35 (5.71%)  0/34 (0.00%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Investigations             
Alanine Aminotransferase Increased † 1  1/28 (3.57%)  2/35 (5.71%)  1/34 (2.94%)  1/22 (4.55%)  0/31 (0.00%)  0/3 (0.00%) 
Aspartate Aminotransferase Increased † 1  0/28 (0.00%)  1/35 (2.86%)  1/34 (2.94%)  2/22 (9.09%)  2/31 (6.45%)  0/3 (0.00%) 
Blood Alkaline Phosphatase Increased † 1  0/28 (0.00%)  4/35 (11.43%)  1/34 (2.94%)  1/22 (4.55%)  3/31 (9.68%)  0/3 (0.00%) 
Blood Creatinine Increased † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  1/22 (4.55%)  1/31 (3.23%)  1/3 (33.33%) 
C-Reactive Protein Increased † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  2/31 (6.45%)  1/3 (33.33%) 
Gamma-Glutamyltransferase Increased † 1  0/28 (0.00%)  2/35 (5.71%)  1/34 (2.94%)  0/22 (0.00%)  3/31 (9.68%)  0/3 (0.00%) 
Heart Rate Increased † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  1/3 (33.33%) 
Hypophonesis † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  2/22 (9.09%)  0/31 (0.00%)  0/3 (0.00%) 
Transaminases Increased † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  2/31 (6.45%)  0/3 (0.00%) 
Weight Decreased † 1  4/28 (14.29%)  1/35 (2.86%)  3/34 (8.82%)  1/22 (4.55%)  4/31 (12.90%)  0/3 (0.00%) 
Metabolism and nutrition disorders             
Decreased Appetite † 1  17/28 (60.71%)  15/35 (42.86%)  12/34 (35.29%)  8/22 (36.36%)  10/31 (32.26%)  1/3 (33.33%) 
Dehydration † 1  1/28 (3.57%)  1/35 (2.86%)  3/34 (8.82%)  1/22 (4.55%)  1/31 (3.23%)  0/3 (0.00%) 
Hyperglycaemia † 1  1/28 (3.57%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  1/31 (3.23%)  1/3 (33.33%) 
Hypokalaemia † 1  2/28 (7.14%)  2/35 (5.71%)  0/34 (0.00%)  2/22 (9.09%)  1/31 (3.23%)  0/3 (0.00%) 
Hypomagnesaemia † 1  1/28 (3.57%)  2/35 (5.71%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Hyponatraemia † 1  2/28 (7.14%)  4/35 (11.43%)  0/34 (0.00%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia † 1  1/28 (3.57%)  4/35 (11.43%)  2/34 (5.88%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Back Pain † 1  8/28 (28.57%)  5/35 (14.29%)  8/34 (23.53%)  3/22 (13.64%)  7/31 (22.58%)  0/3 (0.00%) 
Bone Pain † 1  0/28 (0.00%)  2/35 (5.71%)  1/34 (2.94%)  1/22 (4.55%)  3/31 (9.68%)  0/3 (0.00%) 
Flank Pain † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  4/31 (12.90%)  0/3 (0.00%) 
Muscle Spasms † 1  2/28 (7.14%)  1/35 (2.86%)  1/34 (2.94%)  3/22 (13.64%)  0/31 (0.00%)  0/3 (0.00%) 
Musculoskeletal Chest Pain † 1  1/28 (3.57%)  2/35 (5.71%)  2/34 (5.88%)  1/22 (4.55%)  2/31 (6.45%)  0/3 (0.00%) 
Musculoskeletal Pain † 1  3/28 (10.71%)  2/35 (5.71%)  5/34 (14.71%)  1/22 (4.55%)  2/31 (6.45%)  1/3 (33.33%) 
Myalgia † 1  0/28 (0.00%)  4/35 (11.43%)  4/34 (11.76%)  5/22 (22.73%)  6/31 (19.35%)  1/3 (33.33%) 
Neck Pain † 1  2/28 (7.14%)  0/35 (0.00%)  4/34 (11.76%)  1/22 (4.55%)  2/31 (6.45%)  1/3 (33.33%) 
Pain In Extremity † 1  2/28 (7.14%)  4/35 (11.43%)  4/34 (11.76%)  1/22 (4.55%)  1/31 (3.23%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Cancer Pain † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  1/3 (33.33%) 
Nervous system disorders             
Ataxia † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  1/3 (33.33%) 
Balance Disorder † 1  1/28 (3.57%)  0/35 (0.00%)  0/34 (0.00%)  1/22 (4.55%)  3/31 (9.68%)  0/3 (0.00%) 
Dizziness † 1  1/28 (3.57%)  2/35 (5.71%)  1/34 (2.94%)  1/22 (4.55%)  3/31 (9.68%)  1/3 (33.33%) 
Dysgeusia † 1  2/28 (7.14%)  1/35 (2.86%)  1/34 (2.94%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Headache † 1  8/28 (28.57%)  8/35 (22.86%)  8/34 (23.53%)  14/22 (63.64%)  13/31 (41.94%)  2/3 (66.67%) 
Hypoaesthesia † 1  0/28 (0.00%)  0/35 (0.00%)  2/34 (5.88%)  2/22 (9.09%)  2/31 (6.45%)  0/3 (0.00%) 
Memory Impairment † 1  2/28 (7.14%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Neuralgia † 1  0/28 (0.00%)  3/35 (8.57%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Neuropathy Peripheral † 1  0/28 (0.00%)  0/35 (0.00%)  2/34 (5.88%)  0/22 (0.00%)  1/31 (3.23%)  0/3 (0.00%) 
Paraesthesia † 1  0/28 (0.00%)  0/35 (0.00%)  2/34 (5.88%)  3/22 (13.64%)  3/31 (9.68%)  0/3 (0.00%) 
Peripheral Sensory Neuropathy † 1  0/28 (0.00%)  0/35 (0.00%)  2/34 (5.88%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Somnolence † 1  1/28 (3.57%)  1/35 (2.86%)  2/34 (5.88%)  2/22 (9.09%)  0/31 (0.00%)  0/3 (0.00%) 
Psychiatric disorders             
Anxiety † 1  2/28 (7.14%)  2/35 (5.71%)  3/34 (8.82%)  2/22 (9.09%)  2/31 (6.45%)  0/3 (0.00%) 
Depressed Mood † 1  0/28 (0.00%)  1/35 (2.86%)  2/34 (5.88%)  2/22 (9.09%)  0/31 (0.00%)  0/3 (0.00%) 
Hallucination † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  2/22 (9.09%)  0/31 (0.00%)  0/3 (0.00%) 
Insomnia † 1  0/28 (0.00%)  3/35 (8.57%)  6/34 (17.65%)  5/22 (22.73%)  4/31 (12.90%)  0/3 (0.00%) 
Nervousness † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  2/22 (9.09%)  0/31 (0.00%)  0/3 (0.00%) 
Reproductive system and breast disorders             
Pelvic Pain † 1  0/28 (0.00%)  2/35 (5.71%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Atelectasis † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  2/31 (6.45%)  0/3 (0.00%) 
Cough † 1  5/28 (17.86%)  8/35 (22.86%)  9/34 (26.47%)  7/22 (31.82%)  8/31 (25.81%)  1/3 (33.33%) 
Dysphonia † 1  0/28 (0.00%)  1/35 (2.86%)  2/34 (5.88%)  1/22 (4.55%)  1/31 (3.23%)  0/3 (0.00%) 
Dyspnoea † 1  5/28 (17.86%)  11/35 (31.43%)  9/34 (26.47%)  2/22 (9.09%)  2/31 (6.45%)  1/3 (33.33%) 
Dyspnoea Exertional † 1  0/28 (0.00%)  2/35 (5.71%)  2/34 (5.88%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Epistaxis † 1  0/28 (0.00%)  0/35 (0.00%)  1/34 (2.94%)  0/22 (0.00%)  0/31 (0.00%)  1/3 (33.33%) 
Haemoptysis † 1  4/28 (14.29%)  3/35 (8.57%)  4/34 (11.76%)  1/22 (4.55%)  0/31 (0.00%)  0/3 (0.00%) 
Oropharyngeal Pain † 1  0/28 (0.00%)  1/35 (2.86%)  1/34 (2.94%)  0/22 (0.00%)  3/31 (9.68%)  0/3 (0.00%) 
Pleural Effusion † 1  0/28 (0.00%)  2/35 (5.71%)  3/34 (8.82%)  2/22 (9.09%)  2/31 (6.45%)  0/3 (0.00%) 
Productive Cough † 1  1/28 (3.57%)  4/35 (11.43%)  7/34 (20.59%)  2/22 (9.09%)  1/31 (3.23%)  0/3 (0.00%) 
Rhinorrhoea † 1  0/28 (0.00%)  2/35 (5.71%)  2/34 (5.88%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Wheezing † 1  0/28 (0.00%)  2/35 (5.71%)  0/34 (0.00%)  1/22 (4.55%)  0/31 (0.00%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders             
Dermatitis Acneiform † 1  0/28 (0.00%)  0/35 (0.00%)  0/34 (0.00%)  1/22 (4.55%)  2/31 (6.45%)  0/3 (0.00%) 
Dry Skin † 1  1/28 (3.57%)  3/35 (8.57%)  1/34 (2.94%)  0/22 (0.00%)  4/31 (12.90%)  0/3 (0.00%) 
Pain Of Skin † 1  0/28 (0.00%)  0/35 (0.00%)  2/34 (5.88%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Pruritus † 1  2/28 (7.14%)  1/35 (2.86%)  1/34 (2.94%)  1/22 (4.55%)  4/31 (12.90%)  0/3 (0.00%) 
Rash † 1  2/28 (7.14%)  2/35 (5.71%)  0/34 (0.00%)  1/22 (4.55%)  1/31 (3.23%)  0/3 (0.00%) 
Vascular disorders             
Deep Vein Thrombosis † 1  0/28 (0.00%)  2/35 (5.71%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
Hot Flush † 1  1/28 (3.57%)  0/35 (0.00%)  1/34 (2.94%)  2/22 (9.09%)  1/31 (3.23%)  0/3 (0.00%) 
Hypertension † 1  0/28 (0.00%)  4/35 (11.43%)  3/34 (8.82%)  3/22 (13.64%)  5/31 (16.13%)  0/3 (0.00%) 
Hypotension † 1  0/28 (0.00%)  2/35 (5.71%)  0/34 (0.00%)  0/22 (0.00%)  0/31 (0.00%)  0/3 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: trialandresults.registries@novartis.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01124864     History of Changes
Other Study ID Numbers: CAUY922A2206
2010-020116-11 ( EudraCT Number )
First Submitted: May 14, 2010
First Posted: May 17, 2010
Results First Submitted: July 7, 2015
Results First Posted: March 2, 2016
Last Update Posted: March 2, 2016