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Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01104155
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : February 14, 2017
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Intervention Drug: eribulin mesylate + erlotinib
Enrollment 123
Recruitment Details  
Pre-assignment Details 164 participants were screened. Of these 164 participants, 41 were screening failures, and 123 were randomized into the study. Of the 41 screen failures, 31 participants failed to meet inclusion or exclusion criteria and 10 were excluded due to adverse events, withdrew consent, and other reasons.
Arm/Group Title Eribulin Mesylate Plus Erlotinib, 21 Day Regimen Eribulin Mesylate Plus Erlotinib, 28 Day Regimen
Hide Arm/Group Description Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle. Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
Period Title: Overall Study
Started 63 60
Completed 38 42
Not Completed 25 18
Reason Not Completed
Adverse Event             15             8
Participant choice             6             5
Withdrawal of consent             1             1
Not specified             3             4
Arm/Group Title Eribulin Mesylate Plus Erlotinib, 21 Day Regimen Eribulin Mesylate Plus Erlotinib, 28 Day Regimen Total
Hide Arm/Group Description Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle. Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle. Total of all reporting groups
Overall Number of Baseline Participants 63 60 123
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 60 participants 123 participants
61.7  (11.08) 63.1  (10.05) 62.4  (10.57)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Gender Number Analyzed 63 participants 60 participants 123 participants
Male
33
  52.4%
33
  55.0%
66
  53.7%
Female
30
  47.6%
27
  45.0%
57
  46.3%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants whose best overall response (BOR) was either a confirmed complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for target lesions assessed by computed tomography (CT) or magnetic resonance imaging (MRI) and based on investigator assessment. CRs and PRs had to be confirmed by a repeat assessment of response (CR or PR) separated by at least 4 weeks (28 days). CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have a reduction in short axis to less than 10 millimeters. 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 and the corresponding 95% two-sided confidence intervals (CI) were estimated for each treatment regimen using the Clopper-Pearson method for calculating the exact binomial CI. (CR + PR)
Time Frame From date of first dose of study drug until, or up to the date of data cutoff (07 Apr 2011)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) (Intent-to-treat population) included all participants who took at least one dose of study drug.
Arm/Group Title Eribulin Mesylate Plus Erlotinib, 21 Day Regimen Eribulin Mesylate Plus Erlotinib, 28 Day Regimen
Hide Arm/Group Description:
Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
Overall Number of Participants Analyzed 63 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
12.7
(5.6 to 23.5)
16.7
(8.3 to 28.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eribulin Mesylate Plus Erlotinib, 21 Day Regimen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.204
Comments [Not Specified]
Method 1-sided exact binomial
Comments Based on a one-sided exact binomial test compared to 9%.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Eribulin Mesylate Plus Erlotinib, 28 Day Regimen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method 1-sided exact binomial
Comments [Not Specified]
2.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was assessed for participants with a BOR of CR or PR, and was defined as the time from first documented evidence of CR or PR (whichever status was recorded first) until the first documented sign of disease progression or death (due to any cause), whichever was first. DOR was defined for participants with a confirmed CR or PR. For participants in the subset of responders who did not progress or die, duration of response was censored. DOR was analyzed using the Kaplan-Meier method.
Time Frame From date of first document CR or PR (whichever was recorded first) until first documentation of disease progression or death due to any cause, or up to data cutoff (31 May 2013) up to 3.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Eribulin Mesylate Plus Erlotinib, 21 Day Regimen Eribulin Mesylate Plus Erlotinib, 28 Day Regimen
Hide Arm/Group Description:
Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
Overall Number of Participants Analyzed 63 60
Median (95% Confidence Interval)
Unit of Measure: Months
9.4 [1] 
(2.7 to NA)
9.7 [1] 
(5.6 to NA)
[1]
Not evaluable
3.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was measured as the time from the date of first administration of study treatment until the first documentation of disease progression or death (due to any cause), whichever occurred first, as determined by investigator assessment based on RECIST v1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. For participants who did not have an event (i.e. those who had not progressed, and were alive at the date of data cut-off or lost to Follow-up), progression-free survival was censored. Participants who did not progress in their disease were censored on the date of their last tumor assessment preceding the start of any additional anticancer therapy. PFS was analyzed using the Kaplan-Meier method.
Time Frame From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first), or up to data cutoff (31 May 2013) up to 3.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Eribulin Mesylate Plus Erlotinib, 21 Day Regimen Eribulin Mesylate Plus Erlotinib, 28 Day Regimen
Hide Arm/Group Description:
Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
Overall Number of Participants Analyzed 63 60
Median (95% Confidence Interval)
Unit of Measure: Months
3.5
(1.9 to 4.7)
3.8
(3.3 to 5.5)
4.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description DCR was defined as the percentage of participants who had a BOR of CR or PR, or stable disease (SD; duration of SD lasted for at least 7 weeks). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD was to be greater than or equal to 7 weeks (49 days). A participant's tumor assessment had to be at least 7 weeks following the randomization date to be consider SD. DCR and the corresponding exact Clopper-Pearson 95% CI were computed by treatment regimen. (CR + PR + SD)
Time Frame From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (31 May 2013), up to approximately 3.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Eribulin Mesylate Plus Erlotinib, 21 Day Regimen Eribulin Mesylate Plus Erlotinib, 28 Day Regimen
Hide Arm/Group Description:
Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
Overall Number of Participants Analyzed 63 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
47.6
(34.9 to 60.6)
63.3
(49.9 to 75.4)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the length of time in months from the date of first administration of study drug until the date of death from any cause, and was based on the data cutoff date. In the absence of confirmation of death, participants were censored either at the date that the participant was last known to be alive or the date of study cutoff, whichever came first. OS and the corresponding 2-sided 95% CI was analyzed using the Kaplan-Meier method.
Time Frame From date of first dose of study drug until date of death from any cause or up to data cutoff (31 May 2013), up to approximately 3.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Eribulin Mesylate Plus Erlotinib, 21 Day Regimen Eribulin Mesylate Plus Erlotinib, 28 Day Regimen
Hide Arm/Group Description:
Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
Overall Number of Participants Analyzed 63 60
Median (95% Confidence Interval)
Unit of Measure: Months
7.6
(6.3 to 11.0)
8.5
(6.2 to 13.1)
Time Frame From date of administration of first dose up to 30 days after the last dose, or up to data cutoff (31 May 2013), up to approximately 3.25 years.
Adverse Event Reporting Description Treatment-emergent adverse events (TEAEs) included adverse events that occurred from the first dose of study drug to 30 days after the last dose of study drug, or that were present prior to the first dose of study drug administration but worsened in severity during the study.
 
Arm/Group Title Eribulin Mesylate, 21 Day Cycle Eribulin Mesylate, 28 Day Cycle
Hide Arm/Group Description eribulin mesylate + erlotinib: 21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle. eribulin mesylate + erlotinib: 28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.
All-Cause Mortality
Eribulin Mesylate, 21 Day Cycle Eribulin Mesylate, 28 Day Cycle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eribulin Mesylate, 21 Day Cycle Eribulin Mesylate, 28 Day Cycle
Affected / at Risk (%) Affected / at Risk (%)
Total   38/63 (60.32%)   27/60 (45.00%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  9/63 (14.29%)  2/60 (3.33%) 
Neutropenia  1  4/63 (6.35%)  1/60 (1.67%) 
Cardiac disorders     
Atrial fibrillation  1  0/63 (0.00%)  2/60 (3.33%) 
Cardiac tamponade  1  1/63 (1.59%)  0/60 (0.00%) 
Cardio-respiratory arrest  1  0/63 (0.00%)  1/60 (1.67%) 
Pericardial effusion  1  1/63 (1.59%)  0/60 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  2/63 (3.17%)  0/60 (0.00%) 
Enteritis  1  0/63 (0.00%)  1/60 (1.67%) 
Nausea  1  0/63 (0.00%)  1/60 (1.67%) 
Stomatitis  1  3/63 (4.76%)  1/60 (1.67%) 
Vomiting  1  3/63 (4.76%)  1/60 (1.67%) 
General disorders     
Fatigue  1  0/63 (0.00%)  1/60 (1.67%) 
Non-cardiac chest pain  1  0/63 (0.00%)  1/60 (1.67%) 
Pyrexia  1  3/63 (4.76%)  1/60 (1.67%) 
Asthenia + Fatigue  1  0/63 (0.00%)  1/60 (1.67%) 
Hepatobiliary disorders     
Jaundice cholestatic  1  1/63 (1.59%)  0/60 (0.00%) 
Infections and infestations     
Cellulitis  1  2/63 (3.17%)  0/60 (0.00%) 
Gastroenteritis  1  1/63 (1.59%)  0/60 (0.00%) 
Haematoma infection  1  1/63 (1.59%)  0/60 (0.00%) 
Neutropenic sepsis  1  1/63 (1.59%)  1/60 (1.67%) 
Pneumonia  1  4/63 (6.35%)  3/60 (5.00%) 
Sepsis  1  1/63 (1.59%)  1/60 (1.67%) 
Injury, poisoning and procedural complications     
Fall  1  1/63 (1.59%)  0/60 (0.00%) 
Femoral neck fracture  1  0/63 (0.00%)  1/60 (1.67%) 
Head injury  1  1/63 (1.59%)  0/60 (0.00%) 
Laceration  1  1/63 (1.59%)  0/60 (0.00%) 
Investigations     
Activated partial thromboplastin time prolonged  1  1/63 (1.59%)  0/60 (0.00%) 
International normalised ratio increased  1  1/63 (1.59%)  0/60 (0.00%) 
Neutrophil count decreased  1  4/63 (6.35%)  3/60 (5.00%) 
White blood cell count decreased  1  1/63 (1.59%)  0/60 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  3/63 (4.76%)  2/60 (3.33%) 
Failure to thrive  1  0/63 (0.00%)  1/60 (1.67%) 
Hypoglycaemia  1  2/63 (3.17%)  0/60 (0.00%) 
Hypokalaemia  1  2/63 (3.17%)  0/60 (0.00%) 
Hyponatraemia  1  1/63 (1.59%)  0/60 (0.00%) 
Hypophosphataemia  1  1/63 (1.59%)  0/60 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bone pain  1  1/63 (1.59%)  0/60 (0.00%) 
Flank pain  1  1/63 (1.59%)  0/60 (0.00%) 
Nervous system disorders     
Altered state of consciousness  1  1/63 (1.59%)  0/60 (0.00%) 
Cerebral ischaemia  1  1/63 (1.59%)  0/60 (0.00%) 
Cerebrovascular accident  1  1/63 (1.59%)  0/60 (0.00%) 
Convulsion  1  0/63 (0.00%)  1/60 (1.67%) 
Grand mal convulsion  1  1/63 (1.59%)  0/60 (0.00%) 
Partial seizures  1  1/63 (1.59%)  0/60 (0.00%) 
Syncope  1  0/63 (0.00%)  1/60 (1.67%) 
Renal and urinary disorders     
Renal failure acute  1  1/63 (1.59%)  1/60 (1.67%) 
Haematuria  1  1/63 (1.59%)  0/60 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  2/63 (3.17%)  1/60 (1.67%) 
Chronic obstructive pulmonary disease  1  3/63 (4.76%)  0/60 (0.00%) 
Dyspnoea  1  5/63 (7.94%)  4/60 (6.67%) 
Hypoxia  1  0/63 (0.00%)  1/60 (1.67%) 
Pleural effusion  1  3/63 (4.76%)  1/60 (1.67%) 
Pneumonia aspiration  1  1/63 (1.59%)  0/60 (0.00%) 
Pneumothorax  1  1/63 (1.59%)  0/60 (0.00%) 
Pulmonary embolism  1  0/63 (0.00%)  1/60 (1.67%) 
Pulmonary haemorrhage  1  0/63 (0.00%)  1/60 (1.67%) 
Respiratory failure  1  2/63 (3.17%)  1/60 (1.67%) 
Vascular disorders     
Deep vein thrombosis  1  1/63 (1.59%)  1/60 (1.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eribulin Mesylate, 21 Day Cycle Eribulin Mesylate, 28 Day Cycle
Affected / at Risk (%) Affected / at Risk (%)
Total   63/63 (100.00%)   60/60 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  20/63 (31.75%)  25/60 (41.67%) 
Febrile neutropenia  1  10/63 (15.87%)  2/60 (3.33%) 
Leukopenia  1  5/63 (7.94%)  8/60 (13.33%) 
Neutropenia  1  32/63 (50.79%)  26/60 (43.33%) 
Thrombocytopenia  1  4/63 (6.35%)  3/60 (5.00%) 
Cardiac disorders     
Tachycardia  1  4/63 (6.35%)  3/60 (5.00%) 
Gastrointestinal disorders     
Abdominal pain upper  1  2/63 (3.17%)  5/60 (8.33%) 
Constipation  1  13/63 (20.63%)  21/60 (35.00%) 
Diarrhoea  1  34/63 (53.97%)  26/60 (43.33%) 
Dyspepsia  1  7/63 (11.11%)  6/60 (10.00%) 
Nausea  1  20/63 (31.75%)  22/60 (36.67%) 
Stomatitis  1  21/63 (33.33%)  12/60 (20.00%) 
Vomiting  1  15/63 (23.81%)  16/60 (26.67%) 
General disorders     
Asthenia  1  5/63 (7.94%)  6/60 (10.00%) 
Asthenia + Fatigue  1  31/63 (49.21%)  34/60 (56.67%) 
Chills  1  5/63 (7.94%)  2/60 (3.33%) 
Fatigue  1  29/63 (46.03%)  31/60 (51.67%) 
Mucosal inflammation  1  8/63 (12.70%)  1/60 (1.67%) 
Oedema peripheral  1  5/63 (7.94%)  6/60 (10.00%) 
Pyrexia  1  13/63 (20.63%)  5/60 (8.33%) 
Infections and infestations     
Pneumonia  1  8/63 (12.70%)  5/60 (8.33%) 
Upper respiratory tract infection  1  8/63 (12.70%)  6/60 (10.00%) 
Urinary tract infection  1  6/63 (9.52%)  3/60 (5.00%) 
Investigations     
Neutrophil count decreased  1  10/63 (15.87%)  9/60 (15.00%) 
Weight decreased  1  7/63 (11.11%)  6/60 (10.00%) 
White blood cell count decreased  1  7/63 (11.11%)  7/60 (11.67%) 
Metabolism and nutrition disorders     
Decreased appetite  1  18/63 (28.57%)  24/60 (40.00%) 
Dehydration  1  5/63 (7.94%)  9/60 (15.00%) 
Hypokalaemia  1  16/63 (25.40%)  9/60 (15.00%) 
Hyponatraemia  1  5/63 (7.94%)  7/60 (11.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/63 (11.11%)  4/60 (6.67%) 
Arthralgia + Myalgia  1  11/63 (17.46%)  6/60 (10.00%) 
Back pain  1  7/63 (11.11%)  6/60 (10.00%) 
Muscle spasms  1  4/63 (6.35%)  3/60 (5.00%) 
Myalgia  1  4/63 (6.35%)  4/60 (6.67%) 
Pain in extremity  1  2/63 (3.17%)  6/60 (10.00%) 
Nervous system disorders     
Dizziness  1  6/63 (9.52%)  8/60 (13.33%) 
Dysgeusia  1  4/63 (6.35%)  4/60 (6.67%) 
Headache  1  10/63 (15.87%)  7/60 (11.67%) 
Peripheral Neuropathy  1  5/63 (7.94%)  10/60 (16.67%) 
Peripheral sensory neuropathy  1  4/63 (6.35%)  6/60 (10.00%) 
Psychiatric disorders     
Insomnia  1  4/63 (6.35%)  9/60 (15.00%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  4/63 (6.35%)  5/60 (8.33%) 
Dyspnoea  1  16/63 (25.40%)  18/60 (30.00%) 
Epistaxis  1  10/63 (15.87%)  2/60 (3.33%) 
Haemoptysis  1  5/63 (7.94%)  5/60 (8.33%) 
Oropharyngeal pain  1  7/63 (11.11%)  7/60 (11.67%) 
Pleural effusion  1  5/63 (7.94%)  2/60 (3.33%) 
Productive cough  1  1/63 (1.59%)  6/60 (10.00%) 
Rhinorrhoea  1  4/63 (6.35%)  4/60 (6.67%) 
Cough  1  14/63 (22.22%)  14/60 (23.33%) 
Skin and subcutaneous tissue disorders     
Acne  1  3/63 (4.76%)  4/60 (6.67%) 
Alopecia  1  20/63 (31.75%)  12/60 (20.00%) 
Dermatitis acneiform  1  10/63 (15.87%)  11/60 (18.33%) 
Dry skin  1  9/63 (14.29%)  16/60 (26.67%) 
Pruritus  1  8/63 (12.70%)  8/60 (13.33%) 
Rash  1  27/63 (42.86%)  15/60 (25.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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
Name/Title: Eisai Medical Services
Organization: Eisai, Inc.
Phone: 1-888-422-4743
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01104155     History of Changes
Other Study ID Numbers: E7389-G000-205
First Submitted: April 12, 2010
First Posted: April 15, 2010
Results First Submitted: December 22, 2016
Results First Posted: February 14, 2017
Last Update Posted: January 8, 2019