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A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01218516
Recruitment Status : Completed
First Posted : October 11, 2010
Results First Posted : August 20, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Morphotek

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Adenocarcinoma of the Lung
Interventions Biological: Farletuzumab
Other: Placebo
Drug: Carboplatin
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Cisplatin
Enrollment 130
Recruitment Details  
Pre-assignment Details All screening procedures were completed within 30 days prior to and including the Cycle 1 Day 1 Visit.
Arm/Group Title Combination Therapy: Placebo + Chemotherapy Combination Therapy: Farletuzumab + Chemotherapy Monotherapy: Placebo Monotherapy: Farletuzumab
Hide Arm/Group Description During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks. During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks. Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks. Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
Period Title: Combination Therapy (up to 4.5 Months)
Started 67 63 0 0
Completed 38 28 0 0
Not Completed 29 35 0 0
Reason Not Completed
Death             2             1             0             0
Delay in TA Administration of >=28 days             0             3             0             0
Physician Decision             2             2             0             0
Chemotherapy Discontinued             2             0             0             0
Progressive Disease (PD) by RECIST v 1.1             17             15             0             0
Randomized but Not Treated             0             1             0             0
Withdrew Consent             0             1             0             0
Deterioration of Performance Status             0             3             0             0
Other             3             4             0             0
Toxicity to TA             0             1             0             0
Participant Discontinued Treatment             2             3             0             0
Treatment With Items Outside Protocol             1             1             0             0
Period Title: Monotherapy (up to 23.5 Months)
Started 0 [1] 0 [1] 38 [2] 28 [2]
Safety Analysis Set 0 0 35 31 [3]
Completed 0 0 38 28
Not Completed 0 0 0 0
[1]
This phase ended once all participants finished.
[2]
Only eligible participants entered this phase of the study.
[3]
Three participants were randomized to placebo but actually received Farletuzumab.
Arm/Group Title Combination Therapy: Placebo + Chemotherapy Combination Therapy: Farletuzumab + Chemotherapy Total
Hide Arm/Group Description During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks. During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks. Total of all reporting groups
Overall Number of Baseline Participants 67 63 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 67 participants 63 participants 130 participants
61.0
(46 to 79)
60.0
(38 to 80)
61.0
(38 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 63 participants 130 participants
Female
26
  38.8%
29
  46.0%
55
  42.3%
Male
41
  61.2%
34
  54.0%
75
  57.7%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was defined as the time from the date of randomization to the date of the first observation of investigator-assessed (radiology review) progression based on Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1 or other protocol-approved measures of disease progression (e.g., new occurrence of positive fluid cytology, newly diagnosed evidence of disease progression from histologic samples, PET-positive metastases, or new bone or brain metastases), or date of death, whatever the cause. Disease progression as assessed by the investigator per RECIST v1.0 was defined as at least a 20% increase in sum of longest diameters (RECIST definition) compared to baseline (or lowest sum while on study if less than baseline), or any new lesions (measurable or nonmeasurable).
Time Frame From date of first administration of study drug up to 6 month follow-up from randomization of the last participant, i.e., cut-off date 15 Dec 2012 for primary analysis and cut-off date of 1 Nov 2013 or up to approximately 28 months for final analysis
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants who received at least 1 dose of test article (placebo or farletuzumab), with treatment assignments designated according to actual study treatment received. This was the primary analysis population for evaluating treatment administration, tolerability, and safety.
Arm/Group Title Combination Therapy: Placebo + Chemotherapy Combination Therapy: Farletuzumab + Chemotherapy
Hide Arm/Group Description:
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
Overall Number of Participants Analyzed 67 63
Median (95% Confidence Interval)
Unit of Measure: Months
Per Primary Analysis Cut-Off Date
5.8
(5.0 to 6.8)
4.7
(4.2 to 5.6)
Per Final Analysis Cut-Off Date
5.9
(5.0 to 7.0)
4.7
(4.2 to 5.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combination Therapy: Placebo + Chemotherapy, Combination Therapy: Farletuzumab + Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3519
Comments Per Primary Analysis Cut-Off Date
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.23
Confidence Interval (2-Sided) 80%
0.92 to 1.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combination Therapy: Placebo + Chemotherapy, Combination Therapy: Farletuzumab + Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1555
Comments Per Final Analysis Cut-Off Date
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.34
Confidence Interval (2-Sided) 80%
1.03 to 1.74
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator's radiologic assessments using RECIST 1.1 for target lesions and assessed by Magnetic resonance imaging (MRI) and computerized tomography (CT) scan (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
Time Frame From Day 1 until documented radiographic progression, other protocol-approved measures of disease progression, withdrawal by participant, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants who received at least 1 dose of test article (placebo or farletuzumab), with treatment assignments designated according to actual study treatment received. This was the primary analysis population for evaluating treatment administration, tolerability, and safety.
Arm/Group Title Combination Therapy: Placebo + Chemotherapy Combination Therapy: Farletuzumab + Chemotherapy
Hide Arm/Group Description:
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
Overall Number of Participants Analyzed 67 63
Measure Type: Number
Unit of Measure: Percentage of participants
37.3 41.3
3.Secondary Outcome
Title Duration of Response (DR)
Hide Description DR was derived for those participants with objective evidence of CR or PR. DR was defined as the time (in months) from first documentation of objective response (CR or PR) to the first documentation of disease progression (ie, objective tumor progression as assessed by investigator's radiology review or other protocol-approved measures of disease progression) or death due to any cause. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame From the first documentation of objective response (CR or PR) to the first documentation of disease progression, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
Hide Outcome Measure Data
Hide Analysis Population Description
Tumor Response (TR) Evaluable Analysis Set (responders only) included all participants who received at least 1 dose of test article and who had a baseline assessment and at least 1 on-treatment assessment performed, sufficient to assess the endpoint of interest. The TR Evaluable Analysis Set was used for all RECIST assessments of tumor response.
Arm/Group Title Combination Therapy: Placebo + Chemotherapy Combination Therapy: Farletuzumab + Chemotherapy
Hide Arm/Group Description:
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
Overall Number of Participants Analyzed 25 25
Median (95% Confidence Interval)
Unit of Measure: Months
6.7
(4.1 to 9.4)
4.1
(3.0 to 7.0)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time (in months) from the date of randomization to the date of death, regardless of cause.
Time Frame From the date of randomization to the date of death due to any cause or up to cut-off date of 1 Nov 2013 (up to approximately 28 months) for final analysis
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants who received at least 1 dose of test article (placebo or farletuzumab), with treatment assignments designated according to actual study treatment received. This was the primary analysis population for evaluating treatment administration, tolerability, and safety.
Arm/Group Title Combination Therapy: Placebo + Chemotherapy Combination Therapy: Farletuzumab + Chemotherapy
Hide Arm/Group Description:
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
Overall Number of Participants Analyzed 67 63
Median (95% Confidence Interval)
Unit of Measure: Months
10.5
(8.3 to 14.0)
14.1
(9.5 to 18.6)
5.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Hide Description An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the participant was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, TEAEs (defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Time Frame For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAS) included randomized participants who received at least 1 dose of test article, with treatment assignments designated according to actual study treatment received. This was the primary analysis population for evaluating treatment administration, tolerability, and safety.
Arm/Group Title Combination Therapy: Placebo + Chemotherapy Combination Therapy: Farletuzumab + Chemotherapy Monotherapy: Placebo Monotherapy: Farletuzumab
Hide Arm/Group Description:
During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks.
During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks.
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks.
Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
Overall Number of Participants Analyzed 65 64 35 31
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
60
  92.3%
63
  98.4%
30
  85.7%
25
  80.6%
Treatment emergent SAEs
27
  41.5%
27
  42.2%
6
  17.1%
7
  22.6%
Time Frame For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis
Adverse Event Reporting Description TEAEs, defined as an AE that started/increased in severity on/after the first dose of study drug up to 30 days after final dose of study drug. Per the study Statistical Analysis Plan, the TEAEs presented include serious and non-serious TEAEs. Additionally, serious TEAEs are presented separately.
 
Arm/Group Title Combination Therapy: Placebo + Chemotherapy Combination Therapy: Farletuzumab + Chemotherapy Monotherapy: Placebo Monotherapy: Farletuzumab
Hide Arm/Group Description During Combination Therapy, placebo was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Duration of each cycle=3 weeks. During Combination Therapy, farletuzumab was given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Duration of each cycle=3 weeks. Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Placebo + Chemotherapy) entered the Monotherapy phase and received placebo as monotherapy until disease progression. Duration of each cycle=3 weeks. Following at least 4 cycles, but not more than 6 cycles of combination therapy, participants who experienced clinical benefit from the Combination Therapy (Farletuzumab + Chemotherapy) entered the Monotherapy phase and received farletuzumab as monotherapy until disease progression. Duration of each cycle=3 weeks.
All-Cause Mortality
Combination Therapy: Placebo + Chemotherapy Combination Therapy: Farletuzumab + Chemotherapy Monotherapy: Placebo Monotherapy: Farletuzumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   46/65 (70.77%)      39/64 (60.94%)      1/35 (2.86%)      0/31 (0.00%)    
Hide Serious Adverse Events
Combination Therapy: Placebo + Chemotherapy Combination Therapy: Farletuzumab + Chemotherapy Monotherapy: Placebo Monotherapy: Farletuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/65 (41.54%)      27/64 (42.19%)      6/35 (17.14%)      7/31 (22.58%)    
Blood and lymphatic system disorders         
Febrile neutropenia † 1  5/65 (7.69%)  5 3/64 (4.69%)  3 0/35 (0.00%)  0 0/31 (0.00%)  0
Neutropenia † 1  1/65 (1.54%)  1 2/64 (3.13%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Thrombocytopenia † 1  0/65 (0.00%)  0 2/64 (3.13%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Bone marrow failure † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Anaemia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Cardiac disorders         
Ventricular tachycardia † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Atrial fibrillation † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Pericardial effusion † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Ear and labyrinth disorders         
Vertigo † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Eye disorders         
Diplopia † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Gastrointestinal disorders         
Nausea † 1  0/65 (0.00%)  0 3/64 (4.69%)  3 0/35 (0.00%)  0 0/31 (0.00%)  0
Vomiting † 1  0/65 (0.00%)  0 2/64 (3.13%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Gastrointestinal haemorrhage † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Ileal perforation † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Oesophageal obstruction † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Constipation † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Diarrhoea † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Gastrooesophageal reflux disease † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
General disorders         
Pyrexia † 1  0/65 (0.00%)  0 2/64 (3.13%)  3 0/35 (0.00%)  0 2/31 (6.45%)  2
General physical health deterioration † 1  0/65 (0.00%)  0 2/64 (3.13%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Asthenia † 1  2/65 (3.08%)  2 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Death † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Disease Progression † 1  2/65 (3.08%)  2 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Localised oedema † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Mucosal inflammation † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Oedema peripheral † 1  0/65 (0.00%)  0 1/64 (1.56%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Gait disturbance † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Hepatobiliary disorders         
Hepatobiliary disease † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Immune system disorders         
Hypersensitivity † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Infections and infestations         
Pneumonia † 1  3/65 (4.62%)  3 0/64 (0.00%)  0 1/35 (2.86%)  1 2/31 (6.45%)  2
Catheter site infection † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Empyema † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Liver abscess † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Encephalitic infection † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Upper respiratory tract infection † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Investigations         
Weight decreased † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
International normalised ratio increased † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration † 1  0/65 (0.00%)  0 3/64 (4.69%)  3 0/35 (0.00%)  0 0/31 (0.00%)  0
Diabetes mellitus inadequate control † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Hyperglycaemia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Osteonecrosis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Arthralgia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Bone pain † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Neck pain † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Pathological fracture † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lung neoplasm malignant † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Metastases to central nervous system † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 1/31 (3.23%)  1
Metastases to meninges † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Cancer pain † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Malignant pleural effusion † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Metastatic pain † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Non-Small Cell Lung Cancer † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Nervous system disorders         
Cerebrovascular accident † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 1/35 (2.86%)  1 0/31 (0.00%)  0
Cerebral infarction † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Dysaesthesia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Encephalitis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Epilepsy † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Sciatica † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Psychiatric disorders         
Confusional state † 1  2/65 (3.08%)  3 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Hallucination, auditory † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Hallucination, visual † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Renal and urinary disorders         
Renal failure † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Pleural effusion † 1  2/65 (3.08%)  2 2/64 (3.13%)  2 0/35 (0.00%)  0 1/31 (3.23%)  1
Dyspnoea † 1  2/65 (3.08%)  2 1/64 (1.56%)  1 1/35 (2.86%)  1 1/31 (3.23%)  1
Haemoptysis † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Lung infiltration † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Acute respiratory failure † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Chronic obstructive pulmonary disease † 1  1/65 (1.54%)  2 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Epistaxis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Hypoxia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Respiratory failure † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Pulmonary embolism † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 1/35 (2.86%)  1 1/31 (3.23%)  1
Skin and subcutaneous tissue disorders         
Rash † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Vascular disorders         
Deep vein thrombosis † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Subclavian vein thrombosis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Hypertension † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Superior vena cava syndrome † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
1
Term from vocabulary, MedDRA 14.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Combination Therapy: Placebo + Chemotherapy Combination Therapy: Farletuzumab + Chemotherapy Monotherapy: Placebo Monotherapy: Farletuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   60/65 (92.31%)      63/64 (98.44%)      30/35 (85.71%)      25/31 (80.65%)    
Blood and lymphatic system disorders         
Anaemia † 1  20/65 (30.77%)  24 24/64 (37.50%)  27 4/35 (11.43%)  5 1/31 (3.23%)  1
Neutropenia † 1  10/65 (15.38%)  18 22/64 (34.38%)  34 1/35 (2.86%)  1 0/31 (0.00%)  0
Thrombocytopenia † 1  7/65 (10.77%)  11 8/64 (12.50%)  9 0/35 (0.00%)  0 0/31 (0.00%)  0
Leukopenia † 1  3/65 (4.62%)  6 4/64 (6.25%)  6 0/35 (0.00%)  0 0/31 (0.00%)  0
Febrile neutropenia † 1  5/65 (7.69%)  5 3/64 (4.69%)  3 0/35 (0.00%)  0 0/31 (0.00%)  0
Bone marrow failure † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Coagulopathy † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Leukocytosis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Lymphopenia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Pancytopenia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Normochromic normocytic anaemia † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Cardiac disorders         
Pericardial effusion † 1  2/65 (3.08%)  2 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Tachycardia † 1  2/65 (3.08%)  2 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Angina pectoris † 1  1/65 (1.54%)  4 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Atrial fibrillation † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Atrial flutter † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Bradycardia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Ventricular tachycardia † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Congenital, familial and genetic disorders         
Renal fusion anomaly † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Ear and labyrinth disorders         
Tinnitus † 1  1/65 (1.54%)  1 4/64 (6.25%)  5 0/35 (0.00%)  0 0/31 (0.00%)  0
Ear pain † 1  0/65 (0.00%)  0 2/64 (3.13%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Deafness † 1  1/65 (1.54%)  2 1/64 (1.56%)  1 0/35 (0.00%)  0 1/31 (3.23%)  1
Hearing impaired † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Vertigo † 1  2/65 (3.08%)  3 1/64 (1.56%)  1 0/35 (0.00%)  0 1/31 (3.23%)  2
Cerumen impaction † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Eye disorders         
Conjunctivitis † 1  5/65 (7.69%)  11 3/64 (4.69%)  4 0/35 (0.00%)  0 0/31 (0.00%)  0
Eye irritation † 1  1/65 (1.54%)  1 2/64 (3.13%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Visual acuity reduced † 1  1/65 (1.54%)  1 2/64 (3.13%)  3 0/35 (0.00%)  0 0/31 (0.00%)  0
Dry eye † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Eye pruritus † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Lacrimation increased † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Photopsia † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Visual impairment † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Diplopia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Vision blurred † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Eyelid ptosis † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Gastrointestinal disorders         
Nausea † 1  30/65 (46.15%)  48 29/64 (45.31%)  43 1/35 (2.86%)  1 2/31 (6.45%)  2
Constipation † 1  18/65 (27.69%)  26 20/64 (31.25%)  27 3/35 (8.57%)  6 2/31 (6.45%)  2
Diarrhoea † 1  16/65 (24.62%)  22 18/64 (28.13%)  21 2/35 (5.71%)  2 0/31 (0.00%)  0
Vomiting † 1  16/65 (24.62%)  33 16/64 (25.00%)  25 1/35 (2.86%)  1 1/31 (3.23%)  1
Stomatitis † 1  7/65 (10.77%)  11 6/64 (9.38%)  8 0/35 (0.00%)  0 0/31 (0.00%)  0
Dyspepsia † 1  2/65 (3.08%)  2 4/64 (6.25%)  5 0/35 (0.00%)  0 1/31 (3.23%)  1
Abdominal pain † 1  1/65 (1.54%)  1 2/64 (3.13%)  3 2/35 (5.71%)  2 2/31 (6.45%)  2
Gastrooesophageal reflux disease † 1  5/65 (7.69%)  5 1/64 (1.56%)  1 1/35 (2.86%)  1 1/31 (3.23%)  1
Dysphagia † 1  1/65 (1.54%)  1 2/64 (3.13%)  2 1/35 (2.86%)  1 0/31 (0.00%)  0
Gastrointestinal pain † 1  0/65 (0.00%)  0 2/64 (3.13%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Toothache † 1  0/65 (0.00%)  0 2/64 (3.13%)  3 0/35 (0.00%)  0 1/31 (3.23%)  1
Abdominal discomfort † 1  0/65 (0.00%)  0 1/64 (1.56%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Abdominal pain upper † 1  3/65 (4.62%)  3 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Aphthous stomatitis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Gastrointestinal haemorrhage † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Gingivitis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Ileal perforation † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Odynophagia † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Oesophageal obstruction † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Retching † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Tongue coated † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Abdominal distension † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Anorectal discomfort † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Flatulence † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Oral pain † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Rectal haemorrhage † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Toothache † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Abdominal adhesions † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Proctalgia † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
General disorders         
Asthenia † 1  12/65 (18.46%)  13 22/64 (34.38%)  32 3/35 (8.57%)  3 2/31 (6.45%)  2
Fatigue † 1  29/65 (44.62%)  48 24/64 (37.50%)  29 3/35 (8.57%)  4 1/31 (3.23%)  1
Pyrexia † 1  6/65 (9.23%)  8 9/64 (14.06%)  15 1/35 (2.86%)  1 2/31 (6.45%)  3
Mucosal inflammation † 1  9/65 (13.85%)  15 7/64 (10.94%)  7 0/35 (0.00%)  0 0/31 (0.00%)  0
Oedema peripheral † 1  5/65 (7.69%)  5 6/64 (9.38%)  8 3/35 (8.57%)  3 1/31 (3.23%)  2
Chills † 1  3/65 (4.62%)  3 4/64 (6.25%)  4 0/35 (0.00%)  0 0/31 (0.00%)  0
General physical health deterioration † 1  1/65 (1.54%)  1 3/64 (4.69%)  4 0/35 (0.00%)  0 1/31 (3.23%)  1
Non-cardiac chest pain † 1  1/65 (1.54%)  1 3/64 (4.69%)  3 0/35 (0.00%)  0 1/31 (3.23%)  2
Localised oedema † 1  0/65 (0.00%)  0 2/64 (3.13%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Pain † 1  2/65 (3.08%)  2 2/64 (3.13%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Axillary pain † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Chest discomfort † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Chest pain † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Death † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Disease progression † 1  2/65 (3.08%)  2 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Face oedema † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 1/35 (2.86%)  1 0/31 (0.00%)  0
Feeling cold † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Influenza like illness † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Infusion site urticaria † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Mucosal dryness † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 1/31 (3.23%)  1
Catheter site pain † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Device occlusion † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Gait disturbance † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Infusion site reaction † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Injection site reaction † 1  1/65 (1.54%)  2 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Malaise † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Performance status decreased † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Oedema † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 1/31 (3.23%)  1
Hepatobiliary disorders         
Cholelithiasis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Hepatic steatosis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Hepatobiliary disease † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Hepatic pain † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Immune system disorders         
Hypersensitivity † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Infections and infestations         
Pneumonia † 1  7/65 (10.77%)  7 3/64 (4.69%)  3 2/35 (5.71%)  2 2/31 (6.45%)  2
Upper respiratory tract infection † 1  4/65 (6.15%)  4 3/64 (4.69%)  3 3/35 (8.57%)  3 2/31 (6.45%)  2
Urinary tract infection † 1  4/65 (6.15%)  4 4/64 (6.25%)  4 0/35 (0.00%)  0 0/31 (0.00%)  0
Bronchitis † 1  3/65 (4.62%)  3 2/64 (3.13%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Candidiasis † 1  2/65 (3.08%)  2 2/64 (3.13%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Abdominal Sepsis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Catheter site cellulitis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Catheter site infection † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Herpes dermatitis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Nasopharyngitis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 1/35 (2.86%)  1 0/31 (0.00%)  0
Oral candidiasis † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Otitis media † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Pharyngitis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Skin infection † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Cellulitis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Clostridial infection † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Conjunctivitis infective † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Cystitis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Encephalitic Infection † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Fungal infection † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Gastroenteritis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Lower respiratory tract infection † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Onychomycosis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Pneumonia streptococcal † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Respiratory tract infection † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  2
Respiratory tract infection fungal † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Septic shock † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Tooth abscess † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Furuncle † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  2
Influenza † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Liver abscess † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Rhinitis † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Tonsillitis † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Herpes zoster † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Lymph gland infection † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Respiratory syncytial virus infection † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Empyema † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Injury, poisoning and procedural complications         
Fall † 1  1/65 (1.54%)  1 2/64 (3.13%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Infusion Related Reaction † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Procedural pain † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Radiation pneumonitis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Skeletal injury † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Arthropod sting † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Laceration † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Radiation skin injury † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Humerus fracture † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Limb injury † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Thermal burn † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Investigations         
Weight decreased † 1  3/65 (4.62%)  3 4/64 (6.25%)  4 1/35 (2.86%)  1 0/31 (0.00%)  0
Blood creatinine increased † 1  3/65 (4.62%)  3 1/64 (1.56%)  1 1/35 (2.86%)  1 1/31 (3.23%)  1
Alanine aminotransferase increased † 1  2/65 (3.08%)  2 3/64 (4.69%)  4 0/35 (0.00%)  0 1/31 (3.23%)  1
Aspartate aminotransferase increased † 1  1/65 (1.54%)  1 1/64 (1.56%)  2 0/35 (0.00%)  0 1/31 (3.23%)  1
C-Reactive protein increased † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
International normalised ratio increased † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Blood pressure increased † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 1/35 (2.86%)  3 0/31 (0.00%)  0
Weight increased † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Breath sounds abnormal † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Blood urea increased † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite † 1  14/65 (21.54%)  21 17/64 (26.56%)  19 2/35 (5.71%)  2 1/31 (3.23%)  1
Dehydration † 1  3/65 (4.62%)  3 8/64 (12.50%)  10 0/35 (0.00%)  0 0/31 (0.00%)  0
Hypomagnesaemia † 1  6/65 (9.23%)  6 7/64 (10.94%)  8 1/35 (2.86%)  1 1/31 (3.23%)  1
Hypokalaemia † 1  4/65 (6.15%)  4 5/64 (7.81%)  6 0/35 (0.00%)  0 0/31 (0.00%)  0
Hyponatraemia † 1  0/65 (0.00%)  0 5/64 (7.81%)  5 0/35 (0.00%)  0 0/31 (0.00%)  0
Hyperglycaemia † 1  7/65 (10.77%)  7 1/64 (1.56%)  1 1/35 (2.86%)  1 0/31 (0.00%)  0
Hypochloraemia † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Hypophosphataemia † 1  1/65 (1.54%)  1 1/64 (1.56%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Hypovolaemia † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Increased appetite † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 1/31 (3.23%)  1
Type 2 diabetes mellitus † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Diabetes mellitus inadequate control † 1  1/65 (1.54%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Fluid overload † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Hypercalcaemia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Hypoalbuminaemia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Hypoglycaemia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Metabolic acidosis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Hypocalcaemia † 1  2/65 (3.08%)  2 2/64 (3.13%)  3 0/35 (0.00%)  0 0/31 (0.00%)  0
Hypernatraemia † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Obesity † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Musculoskeletal and connective tissue disorders         
Pain in extremity † 1  2/65 (3.08%)  2 9/64 (14.06%)  11 0/35 (0.00%)  0 1/31 (3.23%)  1
Back pain † 1  6/65 (9.23%)  6 8/64 (12.50%)  11 4/35 (11.43%)  4 1/31 (3.23%)  1
Arthralgia † 1  7/65 (10.77%)  8 7/64 (10.94%)  8 2/35 (5.71%)  2 1/31 (3.23%)  1
Myalgia † 1  2/65 (3.08%)  5 5/64 (7.81%)  8 1/35 (2.86%)  1 2/31 (6.45%)  2
Musculoskeletal pain † 1  1/65 (1.54%)  1 3/64 (4.69%)  3 3/35 (8.57%)  3 1/31 (3.23%)  1
Bone pain † 1  4/65 (6.15%)  4 0/64 (0.00%)  0 3/35 (8.57%)  3 2/31 (6.45%)  2
Muscular weakness † 1  1/65 (1.54%)  1 2/64 (3.13%)  2 1/35 (2.86%)  1 0/31 (0.00%)  0
Muscle spasms † 1  0/65 (0.00%)  0 1/64 (1.56%)  2 0/35 (0.00%)  0 0/31 (0.00%)  0
Osteonecrosis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Pain in jaw † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Coccydynia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Intervertebral disc protrusion † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Musculoskeletal chest pain † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 2/35 (5.71%)  2 0/31 (0.00%)  0
Neck pain † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Osteochondrosis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Pathological fracture † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Tendon pain † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Flank pain † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Muscle atrophy † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Muscle rigidity † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cancer pain † 1  2/65 (3.08%)  2 1/64 (1.56%)  1 2/35 (5.71%)  3 0/31 (0.00%)  0
Lung neoplasm malignant † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Lymphangiosis carcinomatosa † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Metastases to meninges † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Non-small cell lung cancer † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Malignant pleural effusion † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Metastatic pain † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Metastases To central nervous system † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 2/35 (5.71%)  3 0/31 (0.00%)  0
Nervous system disorders         
Dizziness † 1  6/65 (9.23%)  6 8/64 (12.50%)  10 0/35 (0.00%)  0 2/31 (6.45%)  4
Headache † 1  1/65 (1.54%)  1 3/64 (4.69%)  4 1/35 (2.86%)  1 5/31 (16.13%)  5
Paraesthesia † 1  8/65 (12.31%)  9 6/64 (9.38%)  7 2/35 (5.71%)  2 1/31 (3.23%)  1
Dysgeusia † 1  5/65 (7.69%)  5 3/64 (4.69%)  3 0/35 (0.00%)  0 1/31 (3.23%)  1
Neuropathy peripheral † 1  6/65 (9.23%)  6 3/64 (4.69%)  3 1/35 (2.86%)  1 1/31 (3.23%)  1
Polyneuropathy † 1  3/65 (4.62%)  3 4/64 (6.25%)  5 1/35 (2.86%)  1 0/31 (0.00%)  0
Amnesia † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Aphonia † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Cerebrovascular accident † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 1/35 (2.86%)  1 0/31 (0.00%)  0
Dystonia † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Hypoaesthesia † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Neuralgia † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Parosmia † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Restless legs syndrome † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Sensory disturbance † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Balance disorder † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Cerebral cyst † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Cerebral infarction † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Cognitive disorder † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Depressed level of consciousness † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Dysaesthesia † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Encephalitis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Encephalopathy † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Lethargy † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Memory impairment † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Paresis † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Peripheral sensory neuropathy † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Sciatica † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Somnolence † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Syncope † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Tremor † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Carotid arteriosclerosis † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Epilepsy † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 1/31 (3.23%)  1
Facial paresis † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Psychiatric disorders         
Insomnia † 1  5/65 (7.69%)  6 6/64 (9.38%)  6 1/35 (2.86%)  1 2/31 (6.45%)  2
Anxiety † 1  2/65 (3.08%)  4 7/64 (10.94%)  7 0/35 (0.00%)  0 0/31 (0.00%)  0
Confusional state † 1  5/65 (7.69%)  5 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Depression † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Mental status changes † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Hallucination, auditory † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Hallucination, visual † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Panic attack † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Restlessness † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Renal and urinary disorders         
Renal failure † 1  3/65 (4.62%)  3 2/64 (3.13%)  3 0/35 (0.00%)  0 0/31 (0.00%)  0
Renal failure acute † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Urinary incontinence † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Dysuria † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Haematuria † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Oliguria † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Pollakiuria † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Proteinuria † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Renal impairment † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Micturition urgency † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 2/31 (6.45%)  2
Nocturia † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Reproductive system and breast disorders         
Benign prostatic hyperplasia † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Menstruation irregular † 1  0/65 (0.00%)  0 1/64 (1.56%)  3 0/35 (0.00%)  0 0/31 (0.00%)  0
Breast tenderness † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Erectile dysfunction † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Respiratory, thoracic and mediastinal disorders         
Dyspnoea † 1  8/65 (12.31%)  8 12/64 (18.75%)  15 6/35 (17.14%)  6 3/31 (9.68%)  3
Cough † 1  10/65 (15.38%)  11 9/64 (14.06%)  14 4/35 (11.43%)  4 6/31 (19.35%)  6
Dyspnoea exertional † 1  1/65 (1.54%)  1 5/64 (7.81%)  5 1/35 (2.86%)  1 3/31 (9.68%)  3
Epistaxis † 1  4/65 (6.15%)  4 6/64 (9.38%)  6 0/35 (0.00%)  0 0/31 (0.00%)  0
Pleural effusion † 1  3/65 (4.62%)  3 3/64 (4.69%)  4 0/35 (0.00%)  0 2/31 (6.45%)  2
Dysphonia † 1  2/65 (3.08%)  2 4/64 (6.25%)  5 0/35 (0.00%)  0 0/31 (0.00%)  0
Productive cough † 1  1/65 (1.54%)  1 3/64 (4.69%)  4 0/35 (0.00%)  0 1/31 (3.23%)  1
Oropharyngeal pain † 1  3/65 (4.62%)  4 2/64 (3.13%)  2 1/35 (2.86%)  1 2/31 (6.45%)  2
Hiccups † 1  0/65 (0.00%)  0 3/64 (4.69%)  3 0/35 (0.00%)  0 0/31 (0.00%)  0
Lung infiltration † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 1/31 (3.23%)  1
Pleuritic pain † 1  1/65 (1.54%)  1 1/64 (1.56%)  2 2/35 (5.71%)  2 0/31 (0.00%)  0
Pneumonia aspiration † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Pneumonitis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 1/31 (3.23%)  1
Pulmonary fibrosis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Rhinorrhoea † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Rhonchi † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Sputum discoloured † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Throat irritation † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Wheezing † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 2/31 (6.45%)  2
Acute respiratory failure † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Atelectasis † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Chronic obstructive pulmonary disease † 1  1/65 (1.54%)  2 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Haemoptysis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 2/35 (5.71%)  2 2/31 (6.45%)  2
Hypoxia † 1  3/65 (4.62%)  5 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Nasal congestion † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Pneumothorax † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Pulmonary embolism † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 1/35 (2.86%)  1 3/31 (9.68%)  3
Rales † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Respiratory failure † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Alveolitis † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Increased upper airway secretion † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Pleurisy † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Pulmonary haemorrhage † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Skin and subcutaneous tissue disorders         
Rash † 1  4/65 (6.15%)  4 8/64 (12.50%)  9 1/35 (2.86%)  1 0/31 (0.00%)  0
Alopecia † 1  5/65 (7.69%)  7 4/64 (6.25%)  4 1/35 (2.86%)  2 2/31 (6.45%)  2
Dry skin † 1  4/65 (6.15%)  5 3/64 (4.69%)  3 1/35 (2.86%)  1 0/31 (0.00%)  0
Pruritus † 1  4/65 (6.15%)  5 3/64 (4.69%)  3 0/35 (0.00%)  0 0/31 (0.00%)  0
Dermatitis acneiform † 1  1/65 (1.54%)  1 3/64 (4.69%)  3 0/35 (0.00%)  0 0/31 (0.00%)  0
Erythema † 1  0/65 (0.00%)  0 3/64 (4.69%)  3 0/35 (0.00%)  0 0/31 (0.00%)  0
Night sweats † 1  1/65 (1.54%)  1 3/64 (4.69%)  4 1/35 (2.86%)  1 0/31 (0.00%)  0
Skin hyperpigmentation † 1  0/65 (0.00%)  0 3/64 (4.69%)  3 0/35 (0.00%)  0 0/31 (0.00%)  0
Capillaritis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Increased tendency to bruise † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Rash erythematous † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Rash generalised † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Skin ulcer † 1  1/65 (1.54%)  1 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Hyperhidrosis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Petechiae † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Rash vesicular † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Skin exfoliation † 1  3/65 (4.62%)  6 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Nail disorder † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Onychoclasis † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 1/35 (2.86%)  1 0/31 (0.00%)  0
Vascular disorders         
Deep vein thrombosis † 1  4/65 (6.15%)  4 3/64 (4.69%)  3 0/35 (0.00%)  0 1/31 (3.23%)  1
Hypertension † 1  2/65 (3.08%)  5 3/64 (4.69%)  3 2/35 (5.71%)  2 0/31 (0.00%)  0
Hot flush † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Hypertensive crisis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Hypotension † 1  2/65 (3.08%)  3 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Peripheral coldness † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Subclavian vein thrombosis † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Thrombophlebitis superficial † 1  0/65 (0.00%)  0 1/64 (1.56%)  1 0/35 (0.00%)  0 0/31 (0.00%)  0
Orthostatic hypotension † 1  2/65 (3.08%)  2 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Superior vena cava syndrome † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Thrombophlebitis † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Venous occlusion † 1  1/65 (1.54%)  1 0/64 (0.00%)  0 0/35 (0.00%)  0 0/31 (0.00%)  0
Aortic arteriosclerosis † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Arteriosclerosis † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
Jugular vein thrombosis † 1  0/65 (0.00%)  0 0/64 (0.00%)  0 0/35 (0.00%)  0 1/31 (3.23%)  1
1
Term from vocabulary, MedDRA 14.1
†
Indicates events were collected by systematic assessment
[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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Morphotek (subsidiary of Eisai)
Organization: Morphotek (subsidiary of Eisai)
Phone: 1-888-422-4743
EMail: esi_medinfo@eisai.com
Layout table for additonal information
Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT01218516    
Other Study ID Numbers: MORAb-003-009
2010-022229-13 ( EudraCT Number )
First Submitted: October 7, 2010
First Posted: October 11, 2010
Results First Submitted: March 15, 2018
Results First Posted: August 20, 2020
Last Update Posted: August 20, 2020