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A Study of Pemetrexed and Bevacizumab for Participants With Advanced Non-Small Cell Cancer

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ClinicalTrials.gov Identifier: NCT01004250
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : December 25, 2013
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: Pemetrexed
Drug: Cisplatin
Drug: Bevacizumab
Enrollment 109
Recruitment Details  
Pre-assignment Details The study had 3 periods: a baseline period; a study treatment period, including both induction (Ind) and maintenance (Maint) treatment; and a follow-up period.
Arm/Group Title Study Treatment
Hide Arm/Group Description

Induction Therapy:

Bevacizumab: 7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.

Pemetrexed: 500 milligram per square meter (mg/m²) given intravenously on Day 1 for four cycles of Induction Therapy.

Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.

Maintenance Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle (cycle=21 days) and continued until progression or unacceptable toxicity.

Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Period Title: Induction Therapy Period
Started 109
Received at Least One Dose of Study Drug 109
Death (Any Cause) or Disease Progression 21 [1]
Completed 94
Not Completed 15
Reason Not Completed
Adverse Event             10
Entry Criteria Not Met             1
Withdrawal by Subject             2
Physician Decision             2
[1]
Participants (pts) with death or disease progression considered to have completed phase.
Period Title: Maintenance Therapy Period
Started 72 [1]
Death (Any Cause) or Disease Progression 46 [2]
Completed 46
Not Completed 26
Reason Not Completed
Adverse Event             15
Lost to Follow-up             1
Protocol Violation             1
Withdrawal by Subject             5
Physician Decision             4
[1]
Did not enter Maint: 21 pts due to death or disease progression; 1 pts had performance status 2.
[2]
Pts with death or disease progression considered to have completed phase.
Period Title: Follow-Up (FU) Period
Started 101 [1]
Completed 100
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
[1]
Did not enter FU:Death-4pts Ind,1pts Maint; Pt Withdrew-1 pts Ind,1pts Maint; Lost to FU-1 pts Maint
Arm/Group Title Study Treatment
Hide Arm/Group Description

Induction Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.

Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.

Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.

Maintenance Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Overall Number of Baseline Participants 109
Hide Baseline Analysis Population Description
Intent To Treat population who receive at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants
59.1  (8.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants
Female
45
  41.3%
Male
64
  58.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   0.9%
White
108
  99.1%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 109 participants
Spain 12
Denmark 19
Germany 25
Italy 35
Sweden 18
ECOG Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 109 participants
ECOG 0 59
ECOG 1 50
[1]
Measure Description:

Eastern Cooperative Oncology Group (ECOG) Performance Status Classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death):

0 - Fully Active

  1. - Ambulatory, Restricted Strenuous Activity
  2. - Ambulatory, No Work Activities
  3. - Partially Confined to Bed, Limited Self Care
  4. - Completely Disabled
  5. - Death
Initial Pathological Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 109 participants
Adenocarcinoma 99
Large Cell Lung Carcinoma 3
Poorly Differentiated NSCLC 3
Other 4
[1]
Measure Description: Non-Small Cell Lung Cancer (NSCLC)
Stage of Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 109 participants
Stage IIIB 10
Stage IV 99
[1]
Measure Description:

According to American Joint Committee on Cancer (AJCC) Cancer Staging Manual, sixth edition (2002), stage of disease means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body).

Stage IIIB - the cancer has spread to nearby tissue or spread to far away lymph nodes but not spread to other organs

Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver

Tobacco Use  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 109 participants
Never Smoked 15
Ex-Smoker 66
Current Smoker 28
1.Primary Outcome
Title Progression-Free Survival
Hide Description Progression-Free Survival (PFS) is defined as the time from the date of study enrollment to the first date of objectively determined PD or death from any cause. PD is defined using Response Evaluation Criteria in Solid Tumours (RECIST) Guidelines (Version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last objective progression-free disease assessment. For participants who receive subsequent systemic anticancer therapy, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation systemic therapy.
Time Frame From enrollment to the first date of objectively determined Progressive Disease (PD) or death from any cause (every other cycle during study treatment and then every 6 weeks during follow-up period)(Baseline up to 36.1 Months)
Hide Outcome Measure Data
Hide Analysis Population Description

30 participants were censored. Participants qualified by the following criteria:

  • Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer
  • At least 1 unidimensionally measurable lesion
  • No concomitant curative anticancer therapy
  • Treated with at least one dose of study drug
Arm/Group Title Study Treatment
Hide Arm/Group Description:

Induction Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.

Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.

Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.

Maintenance Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Overall Number of Participants Analyzed 109
Median (90% Confidence Interval)
Unit of Measure: Months
6.9
(5.7 to 8.3)
2.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival (OS) is defined as the time from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS will be censored at the last contact date.
Time Frame From enrollment to the date of death from any cause (every cycle during study treatment, every 6 weeks during follow-up period until PD, and then at least every 3 Months) (Baseline up to 36.3 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
32 participants were censored. All enrolled participants receiving at least one dose of study drug.
Arm/Group Title Study Treatment
Hide Arm/Group Description:

Induction Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.

Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.

Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.

Maintenance Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Overall Number of Participants Analyzed 109
Median (95% Confidence Interval)
Unit of Measure: Months
14.7
(11.5 to 19.7)
3.Secondary Outcome
Title Percentage of Participants With Confirmed Complete Response or Partial Response During Study Treatment (Induction and Maintenance)
Hide Description Overall Response Rate (ORR) is defined as the percentage of participants whose best response is complete response (CR) or partial response (PR) per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.
Time Frame From enrollment to objectively determined PD (assessment during study treatment completed at every other cycle till PD and at 30 day follow-up)(Baseline up to 104.1 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Participants qualified by the following criteria:

  • Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer
  • At least 1 unidimensionally measurable lesion
  • No concomitant curative anticancer therapy
  • Treated with at least one dose of study drug
Arm/Group Title Study Treatment
Hide Arm/Group Description:

Induction Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.

Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.

Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.

Maintenance Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Overall Number of Participants Analyzed 109
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
42.2
(32.8 to 52.0)
4.Secondary Outcome
Title Percentage of Participants With Confirmed Response Complete or Partial Response During the Induction Treatment Only
Hide Description CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.
Time Frame From the time of study enrollment to the first date of objectively determined PD during the induction therapy (assessment during study treatment completed at every other cycle up to four cycles) (Baseline up to 4 cycles)
Hide Outcome Measure Data
Hide Analysis Population Description

Participants qualified by the following criteria:

  • Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer
  • At least 1 unidimensionally measurable lesion
  • No concomitant curative anticancer therapy
  • Treated with at least one dose of study drug
Arm/Group Title Study Treatment
Hide Arm/Group Description:

Induction Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.

Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.

Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.

Overall Number of Participants Analyzed 109
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
34.9
(26.0 to 44.6)
5.Secondary Outcome
Title Percentage of Participants With Confirmed Complete Response or Partial Response During the Maintenance Therapy Only
Hide Description CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.
Time Frame From the start of the maintenance to the first date of objectively determined PD during the maintenance therapy (assessment during maintenance treatment completed at every other cycle till PD and at 30 day follow-up)(Cycle 5 up to 104.1 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Participants qualified by the following criteria:

  • Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer
  • At least 1 unidimensionally measurable lesion
  • No concomitant curative anticancer therapy
  • Treated with at least one dose of study drug
Arm/Group Title Study Treament
Hide Arm/Group Description:

Induction Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.

Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.

Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.

Maintenance Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Overall Number of Participants Analyzed 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
11.1
(4.9 to 20.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Induction Therapy Maintenance Therapy Overall Study Treatment
Hide Arm/Group Description

Induction Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.

Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.

Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.

Maintenance Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Induction Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.

Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.

Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.

Maintenance Therapy:

Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.

All-Cause Mortality
Induction Therapy Maintenance Therapy Overall Study Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Induction Therapy Maintenance Therapy Overall Study Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/109 (29.36%)      14/72 (19.44%)      39/109 (35.78%)    
Blood and lymphatic system disorders       
Anaemia  1  0/109 (0.00%)  0 2/72 (2.78%)  2 2/109 (1.83%)  2
Febrile neutropenia  1  0/109 (0.00%)  0 1/72 (1.39%)  1 1/109 (0.92%)  1
Leukopenia  1  0/109 (0.00%)  0 2/72 (2.78%)  2 2/109 (1.83%)  2
Lymphopenia  1  0/109 (0.00%)  0 1/72 (1.39%)  1 1/109 (0.92%)  1
Neutropenia  1  1/109 (0.92%)  1 1/72 (1.39%)  1 2/109 (1.83%)  2
Thrombocytopenia  1  1/109 (0.92%)  1 1/72 (1.39%)  1 2/109 (1.83%)  2
Cardiac disorders       
Atrial fibrillation  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Left ventricular dysfunction  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Myocardial infarction  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Pericardial effusion  1  0/109 (0.00%)  0 1/72 (1.39%)  1 1/109 (0.92%)  1
Ear and labyrinth disorders       
Vertigo  1  0/109 (0.00%)  0 1/72 (1.39%)  1 1/109 (0.92%)  1
Gastrointestinal disorders       
Abdominal pain  1  1/109 (0.92%)  1 1/72 (1.39%)  1 1/109 (0.92%)  1
Constipation  1  1/109 (0.92%)  1 1/72 (1.39%)  1 1/109 (0.92%)  1
Diarrhoea  1  3/109 (2.75%)  3 0/72 (0.00%)  0 3/109 (2.75%)  3
Gastrointestinal haemorrhage  1 [1]  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Gastrointestinal perforation  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Large intestine perforation  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Nausea  1  3/109 (2.75%)  3 2/72 (2.78%)  2 4/109 (3.67%)  4
Vomiting  1  2/109 (1.83%)  2 1/72 (1.39%)  1 3/109 (2.75%)  3
General disorders       
Asthenia  1  1/109 (0.92%)  1 1/72 (1.39%)  1 2/109 (1.83%)  2
Chest pain  1  2/109 (1.83%)  2 0/72 (0.00%)  0 2/109 (1.83%)  2
General physical health deterioration  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Impaired healing  1  0/109 (0.00%)  0 1/72 (1.39%)  1 1/109 (0.92%)  1
Oedema peripheral  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Pain  1  0/109 (0.00%)  0 3/72 (4.17%)  3 3/109 (2.75%)  3
Pyrexia  1  4/109 (3.67%)  4 1/72 (1.39%)  1 5/109 (4.59%)  5
Sudden death  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Infections and infestations       
Appendicitis  1  0/109 (0.00%)  0 1/72 (1.39%)  2 1/109 (0.92%)  2
Bronchopneumonia  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Lower respiratory tract infection  1  0/109 (0.00%)  0 1/72 (1.39%)  1 1/109 (0.92%)  1
Pneumonia  1  1/109 (0.92%)  1 2/72 (2.78%)  2 3/109 (2.75%)  3
Postoperative wound infection  1  2/109 (1.83%)  2 0/72 (0.00%)  0 2/109 (1.83%)  2
Respiratory tract infection  1  1/109 (0.92%)  1 1/72 (1.39%)  1 2/109 (1.83%)  2
Upper respiratory tract infection  1  1/109 (0.92%)  1 1/72 (1.39%)  1 2/109 (1.83%)  2
Urinary tract infection  1  0/109 (0.00%)  0 1/72 (1.39%)  1 1/109 (0.92%)  1
Investigations       
Platelet count decreased  1  0/109 (0.00%)  0 1/72 (1.39%)  1 1/109 (0.92%)  1
White blood cell count decreased  1  0/109 (0.00%)  0 1/72 (1.39%)  1 1/109 (0.92%)  1
Metabolism and nutrition disorders       
Cachexia  1  0/109 (0.00%)  0 1/72 (1.39%)  1 1/109 (0.92%)  1
Decreased appetite  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Dehydration  1  2/109 (1.83%)  2 0/72 (0.00%)  0 2/109 (1.83%)  2
Hyperkalaemia  1  1/109 (0.92%)  1 1/72 (1.39%)  1 2/109 (1.83%)  2
Musculoskeletal and connective tissue disorders       
Bone pain  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Metastatic pain  1  1/109 (0.92%)  1 1/72 (1.39%)  1 2/109 (1.83%)  2
Tumour pain  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Nervous system disorders       
Coma  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Syncope  1  1/109 (0.92%)  1 1/72 (1.39%)  1 2/109 (1.83%)  2
Transient global amnesia  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Transient ischaemic attack  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Psychiatric disorders       
Anxiety  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Renal and urinary disorders       
Renal failure acute  1  0/109 (0.00%)  0 1/72 (1.39%)  1 1/109 (0.92%)  1
Respiratory, thoracic and mediastinal disorders       
Haemoptysis  1 [2]  2/109 (1.83%)  2 0/72 (0.00%)  0 2/109 (1.83%)  2
Idiopathic pulmonary fibrosis  1  0/109 (0.00%)  0 1/72 (1.39%)  1 1/109 (0.92%)  1
Pleural effusion  1  2/109 (1.83%)  2 1/72 (1.39%)  1 3/109 (2.75%)  3
Pneumonia aspiration  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Pulmonary embolism  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Respiratory failure  1  0/109 (0.00%)  0 1/72 (1.39%)  1 1/109 (0.92%)  1
Vascular disorders       
Deep vein thrombosis  1  3/109 (2.75%)  3 0/72 (0.00%)  0 3/109 (2.75%)  3
Hypotension  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Thrombosis  1  1/109 (0.92%)  1 0/72 (0.00%)  0 1/109 (0.92%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
[1]
Event resulted in death
[2]
Event resulted in 1 death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Induction Therapy Maintenance Therapy Overall Study Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   105/109 (96.33%)      68/72 (94.44%)      106/109 (97.25%)    
Blood and lymphatic system disorders       
Anaemia  1  8/109 (7.34%)  8 1/72 (1.39%)  1 9/109 (8.26%)  9
Leukopenia  1  9/109 (8.26%)  15 4/72 (5.56%)  12 11/109 (10.09%)  31
Neutropenia  1  18/109 (16.51%)  29 12/72 (16.67%)  27 22/109 (20.18%)  60
Cardiac disorders       
Palpitations  1  0/109 (0.00%)  0 4/72 (5.56%)  4 4/109 (3.67%)  4
Ear and labyrinth disorders       
Tinnitus  1  9/109 (8.26%)  10 2/72 (2.78%)  2 11/109 (10.09%)  12
Eye disorders       
Lacrimation increased  1  11/109 (10.09%)  11 7/72 (9.72%)  9 16/109 (14.68%)  19
Gastrointestinal disorders       
Constipation  1  28/109 (25.69%)  33 16/72 (22.22%)  21 39/109 (35.78%)  54
Diarrhoea  1  17/109 (15.60%)  18 11/72 (15.28%)  12 25/109 (22.94%)  29
Dyspepsia  1  9/109 (8.26%)  10 6/72 (8.33%)  6 14/109 (12.84%)  15
Gastritis  1  3/109 (2.75%)  3 4/72 (5.56%)  4 6/109 (5.50%)  7
Nausea  1  60/109 (55.05%)  100 17/72 (23.61%)  27 64/109 (58.72%)  128
Stomatitis  1  9/109 (8.26%)  13 9/72 (12.50%)  12 17/109 (15.60%)  25
Vomiting  1  21/109 (19.27%)  28 10/72 (13.89%)  17 25/109 (22.94%)  45
General disorders       
Asthenia  1  5/109 (4.59%)  6 4/72 (5.56%)  6 9/109 (8.26%)  12
Chest pain  1  7/109 (6.42%)  7 3/72 (4.17%)  3 9/109 (8.26%)  10
Fatigue  1  42/109 (38.53%)  47 20/72 (27.78%)  22 51/109 (46.79%)  63
Influenza like illness  1  1/109 (0.92%)  1 6/72 (8.33%)  6 7/109 (6.42%)  7
Mucosal inflammation  1  12/109 (11.01%)  15 5/72 (6.94%)  6 14/109 (12.84%)  20
Oedema peripheral  1  5/109 (4.59%)  5 10/72 (13.89%)  10 14/109 (12.84%)  14
Pain  1  2/109 (1.83%)  2 5/72 (6.94%)  5 7/109 (6.42%)  7
Pyrexia  1  11/109 (10.09%)  12 9/72 (12.50%)  22 17/109 (15.60%)  34
Infections and infestations       
Infection  1  2/109 (1.83%)  2 4/72 (5.56%)  5 6/109 (5.50%)  7
Nasopharyngitis  1  3/109 (2.75%)  3 3/72 (4.17%)  4 6/109 (5.50%)  7
Upper respiratory tract infection  1  2/109 (1.83%)  2 7/72 (9.72%)  8 8/109 (7.34%)  10
Investigations       
Blood creatinine increased  1  0/109 (0.00%)  0 7/72 (9.72%)  7 7/109 (6.42%)  7
Haemoglobin decreased  1  3/109 (2.75%)  3 5/72 (6.94%)  5 7/109 (6.42%)  9
Weight decreased  1  8/109 (7.34%)  8 4/72 (5.56%)  4 11/109 (10.09%)  11
Metabolism and nutrition disorders       
Decreased appetite  1  9/109 (8.26%)  10 15/72 (20.83%)  18 22/109 (20.18%)  29
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/109 (1.83%)  2 9/72 (12.50%)  12 10/109 (9.17%)  14
Back pain  1  3/109 (2.75%)  3 3/72 (4.17%)  3 6/109 (5.50%)  6
Bone pain  1  5/109 (4.59%)  5 8/72 (11.11%)  8 12/109 (11.01%)  12
Musculoskeletal pain  1  2/109 (1.83%)  2 4/72 (5.56%)  5 6/109 (5.50%)  7
Myalgia  1  2/109 (1.83%)  3 5/72 (6.94%)  7 6/109 (5.50%)  10
Pain in extremity  1  1/109 (0.92%)  1 6/72 (8.33%)  8 7/109 (6.42%)  9
Nervous system disorders       
Dizziness  1  5/109 (4.59%)  5 5/72 (6.94%)  5 10/109 (9.17%)  11
Dysgeusia  1  5/109 (4.59%)  5 5/72 (6.94%)  5 10/109 (9.17%)  10
Headache  1  12/109 (11.01%)  12 10/72 (13.89%)  11 19/109 (17.43%)  22
Neuropathy peripheral  1  3/109 (2.75%)  3 4/72 (5.56%)  6 6/109 (5.50%)  9
Paraesthesia  1  7/109 (6.42%)  7 4/72 (5.56%)  4 10/109 (9.17%)  11
Peripheral sensory neuropathy  1  9/109 (8.26%)  9 10/72 (13.89%)  12 17/109 (15.60%)  20
Psychiatric disorders       
Anxiety  1  3/109 (2.75%)  3 3/72 (4.17%)  3 6/109 (5.50%)  6
Insomnia  1  8/109 (7.34%)  8 4/72 (5.56%)  4 12/109 (11.01%)  12
Renal and urinary disorders       
Proteinuria  1  5/109 (4.59%)  5 3/72 (4.17%)  4 7/109 (6.42%)  8
Respiratory, thoracic and mediastinal disorders       
Cough  1  11/109 (10.09%)  13 15/72 (20.83%)  19 22/109 (20.18%)  29
Dysphonia  1  5/109 (4.59%)  5 3/72 (4.17%)  3 8/109 (7.34%)  8
Dyspnoea  1  8/109 (7.34%)  8 15/72 (20.83%)  19 16/109 (14.68%)  22
Epistaxis  1  16/109 (14.68%)  19 14/72 (19.44%)  19 28/109 (25.69%)  38
Oropharyngeal pain  1  1/109 (0.92%)  1 7/72 (9.72%)  8 8/109 (7.34%)  9
Rhinorrhoea  1  7/109 (6.42%)  7 1/72 (1.39%)  2 8/109 (7.34%)  10
Skin and subcutaneous tissue disorders       
Alopecia  1  7/109 (6.42%)  7 5/72 (6.94%)  7 11/109 (10.09%)  16
Dry skin  1  1/109 (0.92%)  1 4/72 (5.56%)  4 5/109 (4.59%)  5
Rash  1  3/109 (2.75%)  4 6/72 (8.33%)  8 8/109 (7.34%)  11
Vascular disorders       
Hypertension  1  14/109 (12.84%)  14 14/72 (19.44%)  16 23/109 (21.10%)  26
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01004250     History of Changes
Other Study ID Numbers: 13034
H3E-EW-S125 ( Other Identifier: Eli Lilly and Company )
First Submitted: October 28, 2009
First Posted: October 29, 2009
Results First Submitted: November 7, 2013
Results First Posted: December 25, 2013
Last Update Posted: May 21, 2014