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Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer

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ClinicalTrials.gov Identifier: NCT00415636
Recruitment Status : Completed
First Posted : December 25, 2006
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Interventions Drug: IC83/LY2603618
Drug: pemetrexed
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2603618 40 mg/m^2 (4.5-hour Infusion) LY2603618 40 mg/m^2 (1-hour Infusion) LY2603618 70 mg/m^2 LY2603618 105 mg/m^2 LY2603618 150 mg/m^2 LY2603618 195 mg/m^2
Hide Arm/Group Description LY2603618 40 milligrams per square meter (mg/m^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed. Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m^2 [4.5-hour infusion]), LY2603618 40 mg/m^2 dose in Cohort 2 (LY2603618 40 mg/m^2 [1-hour infusion]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed. Beginning with Cohort 3 (LY2603618 70 mg/m^2), dose modifications were allowed. LY2603618 70 mg/m^2 was administered over the course of 1 hour. LY2603618 105 mg/m^2 administered over the duration of 1 hour. LY2603618 150 mg/m^2 administered over the duration of 1 hour. LY2603618 195 mg/m^2 administered over the duration of 1 hour.
Period Title: Overall Study
Started 3 3 3 13 6 3
Completed 2 [1] 3 [1] 2 [1] 7 [1] 4 [1] 1 [1]
Not Completed 1 0 1 6 2 2
Reason Not Completed
Symptomatic deterioration             1             0             1             2             0             1
Adverse Event             0             0             0             1             1             0
Withdrawal by Subject             0             0             0             0             1             0
Disease progression             0             0             0             3             0             1
[1]
Completed = Participant received 2 cycles of treatment
Arm/Group Title LY2603618 40 mg/m^2 (4.5-hour Infusion) LY2603618 40 mg/m^2 (1-hour Infusion) LY2603618 70 mg/m^2 LY2603618 105 mg/m^2 LY2603618 150 mg/m^2 LY2603618 195 mg/m^2 Total
Hide Arm/Group Description LY2603618 40 milligrams per square meter (mg/m^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed. Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m^2 [4.5-hour infusion]), LY2603618 40 mg/m^2 dose in Cohort 2 (LY2603618 40 mg/m^2 [1-hour infusion]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed. Beginning with Cohort 3 (LY2603618 70 mg/m^2), dose modifications were allowed. LY2603618 70 mg/m^2 was administered over the course of 1 hour. LY2603618 105 mg/m^2 administered over the duration of 1 hour. LY2603618 150 mg/m^2 administered over the duration of 1 hour. LY2603618 195 mg/m^2 administered over the duration of 1 hour. Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 13 6 3 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 3 participants 13 participants 6 participants 3 participants 31 participants
49.0  (6.24) 58.0  (10.54) 48.3  (16.07) 60.6  (9.95) 63.5  (11.04) 55.7  (18.77) 58.1  (11.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 13 participants 6 participants 3 participants 31 participants
Female
3
 100.0%
1
  33.3%
2
  66.7%
5
  38.5%
3
  50.0%
1
  33.3%
15
  48.4%
Male
0
   0.0%
2
  66.7%
1
  33.3%
8
  61.5%
3
  50.0%
2
  66.7%
16
  51.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 13 participants 6 participants 3 participants 31 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.7%
0
   0.0%
0
   0.0%
1
   3.2%
Not Hispanic or Latino
3
 100.0%
3
 100.0%
3
 100.0%
12
  92.3%
6
 100.0%
3
 100.0%
30
  96.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 13 participants 6 participants 3 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
1
   3.2%
Asian
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
White
2
  66.7%
3
 100.0%
2
  66.7%
13
 100.0%
6
 100.0%
2
  66.7%
28
  90.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 3 participants 13 participants 6 participants 3 participants 31 participants
3
 100.0%
3
 100.0%
3
 100.0%
13
 100.0%
6
 100.0%
3
 100.0%
31
 100.0%
Primary Cancer Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 13 participants 6 participants 3 participants 31 participants
Breast 3 1 1 0 1 0 6
Non-small Cell Lung 0 0 0 1 0 0 1
Pancreatic 0 0 0 3 2 1 6
Other 0 2 2 9 3 2 18
Eastern Cooperative Oncology Group (ECOG) Rating at Screening   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 13 participants 6 participants 3 participants 31 participants
ECOG Rating 0 2 1 0 4 1 0 8
ECOG Rating 1 1 2 3 9 5 3 23
[1]
Measure Description: Classifies participants according to their functional impairment. Scores range from 0 to 5: 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.
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
Time Frame baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was comprised of all participants who received any amount of LY2603618.
Arm/Group Title LY2603618 40 mg/m^2 (4.5-hour Infusion) LY2603618 40 mg/m^2 (1-hour Infusion) LY2603618 70 mg/m^2 LY2603618 105 mg/m^2 LY2603618 150 mg/m^2 LY2603618 195 mg/m^2
Hide Arm/Group Description:
4.5-hour intravenous (IV) infusion of IC83/LY2603618 40 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 40 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 70 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 105 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 150 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 195 mg/m^2
Overall Number of Participants Analyzed 3 3 3 13 6 3
Measure Type: Count of Participants
Unit of Measure: Participants
Other Non-Serious Adverse Events (AEs) 3 3 3 13 6 3
Serious Adverse Events (SAEs) 1 0 2 8 4 2
2.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618
Hide Description Cmax was estimated from the plasma concentration data of LY2603618 versus time profiles.
Time Frame Day 1 and Day 9 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analyses were conducted for individual participants who received at least 1 dose of study drug and had PK samples collected.
Arm/Group Title LY2603618 40 mg/m^2 (4.5-hour Infusion) LY2603618 40 mg/m^2 (1-hour Infusion) LY2603618 70 mg/m^2 LY2603618 105 mg/m^2 LY2603618 150 mg/m^2 LY2603618 195 mg/m^2
Hide Arm/Group Description:
4.5-hour intravenous (IV) infusion of IC83/LY2603618 40 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
1.0-hour IV infusion of IC83/LY2603618 40 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
1.0-hour IV infusion of IC83/LY2603618 70 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
1.0-hour IV infusion of IC83/LY2603618 105 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
1.0-hour IV infusion of IC83/LY2603618 150 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
1.0-hour IV infusion of IC83/LY2603618 195 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
Overall Number of Participants Analyzed 3 3 3 13 6 3
Mean (Standard Deviation)
Unit of Measure: nanograms per millimeter (ng/mL)
Day 1 Number Analyzed 3 participants 3 participants 3 participants 13 participants 6 participants 3 participants
578  (181) 1560  (358) 2310  (1330) 4220  (1370) 4230  (1370) 6840  (839)
Day 9 Number Analyzed 3 participants 3 participants 3 participants 12 participants 5 participants 3 participants
614  (169) 2010  (581) 2510  (942) 4540  (2270) 3560  (1320) 7580  (1260)
3.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞])
Hide Description AUC[0-∞] was calculated from the plasma concentration data of LY2603618 versus time profiles.
Time Frame Day 1 and Day 9 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analyses were conducted for individual participants who received at least 1 dose of study drug and had PK samples collected.
Arm/Group Title LY2603618 40 mg/m^2 (4.5-hour Infusion) LY2603618 40 mg/m^2 (1-hour Infusion) LY2603618 70 mg/m^2 LY2603618 105 mg/m^2 LY2603618 150 mg/m^2 LY2603618 195 mg/m^2
Hide Arm/Group Description:
4.5-hour intravenous (IV) infusion of IC83/LY2603618 40 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
1.0-hour IV infusion of IC83/LY2603618 40 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
1.0-hour IV infusion of IC83/LY2603618 70 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
1.0-hour IV infusion of IC83/LY2603618 105 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
1.0-hour IV infusion of IC83/LY2603618 150 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
1.0-hour IV infusion of IC83/LY2603618 195 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
Overall Number of Participants Analyzed 3 3 3 13 6 3
Mean (Standard Deviation)
Unit of Measure: nanograms*hour per milliliter (ng*h/mL)
Day 1 Number Analyzed 3 participants 3 participants 3 participants 13 participants 6 participants 3 participants
7580  (790) 10300  (2810) 9510  (5560) 76400  (65000) 61900  (53300) 122000  (42000)
Day 9 Number Analyzed 3 participants 3 participants 3 participants 12 participants 5 participants 3 participants
7540  (1790) 11000  (2550) 10900  (6280) 52000  (33900) 55000  (45000) 119000  (30300)
4.Secondary Outcome
Title Percentage of Participants With Best Overall Response
Hide Description Percentage of participants with tumor response (best confirmed overall response) assessed as complete response (CR) or partial response (PR) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD) =small changes that do not meet above criteria. Best Overall Response (%)=number of participants with CR+PR/number of participants in treatment arm * 100.
Time Frame baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
A modified intent-to-treat population (mITT) was used to summarize the data for tumor response. The mITT population consisted of all participants who received any dose of study drug and had at least 1 nonmissing postbaseline tumor response assessment.
Arm/Group Title LY2603618 40 mg/m^2 (4.5 Hours) LY2603618 40 mg/m^2 (1 Hour) LY2603618 70 mg/m^2 LY2603618 105 mg/m^2 LY2603618 150 mg/m^2 LY2603618 195 mg/m^2
Hide Arm/Group Description:
4.5-hour IV infusion of IC83/LY2603618 40 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 40 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 70 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 105 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 150 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 195 mg/m^2
Overall Number of Participants Analyzed 2 3 2 10 4 2
Measure Type: Number
Unit of Measure: Percentage of participants
Complete Response (CR) 0 0 0 0 0 0
Partial Response (PR) 0 0 0 10 0 0
Stable Disease (SD) 0 66.7 50 20 75 50
Progressive Disease (PD) 100 33.3 50 70 25 50
Not Determined 0 0 0 0 0 0
Best Overall Response (CR + PR) 0 0 0 10 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2603618 40 mg/m^2 (4.5-hour Infusion) LY2603618 40 mg/m^2 (1-hour Infusion) LY2603618 70 mg/m^2 LY2603618 105 mg/m^2 LY2603618 150 mg/m^2 LY2603618 195 mg/m^2
Hide Arm/Group Description LY2603618 40 milligrams per square meter (mg/m^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed. Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m^2 [4.5-hour infusion]), LY2603618 40 mg/m^2 dose in Cohort 2 (LY2603618 40 mg/m^2 [1-hour infusion]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed. Beginning with Cohort 3 (LY2603618 70 mg/m^2), dose modifications were allowed. LY2603618 70 mg/m^2 was administered over the course of 1 hour. LY2603618 105 mg/m^2 administered over the duration of 1 hour. LY2603618 150 mg/m^2 administered over the duration of 1 hour. LY2603618 195 mg/m^2 administered over the duration of 1 hour.
All-Cause Mortality
LY2603618 40 mg/m^2 (4.5-hour Infusion) LY2603618 40 mg/m^2 (1-hour Infusion) LY2603618 70 mg/m^2 LY2603618 105 mg/m^2 LY2603618 150 mg/m^2 LY2603618 195 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
LY2603618 40 mg/m^2 (4.5-hour Infusion) LY2603618 40 mg/m^2 (1-hour Infusion) LY2603618 70 mg/m^2 LY2603618 105 mg/m^2 LY2603618 150 mg/m^2 LY2603618 195 mg/m^2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/3 (0.00%)      2/3 (66.67%)      8/13 (61.54%)      4/6 (66.67%)      2/3 (66.67%)    
Blood and lymphatic system disorders             
Anaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/6 (16.67%)  1 1/3 (33.33%)  1
Leukopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Neutropenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Pancytopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 2/3 (66.67%)  2
Cardiac disorders             
Atrial fibrillation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Cardiac arrest  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders             
Abdominal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Diarrhoea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal haemorrhage  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Lower gastrointestinal haemorrhage  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1
Pancreatitis acute  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Small intestinal obstruction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  2 1/6 (16.67%)  2 0/3 (0.00%)  0
General disorders             
Fatigue  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Infusion related reaction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Pyrexia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1
Hepatobiliary disorders             
Hepatic cyst  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Hyperbilirubinaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations             
Cellulitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  2 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Pneumonia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Injury, poisoning and procedural complications             
Hip fracture  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Investigations             
Blood bilirubin increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders             
Dehydration  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Hypokalaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders             
Convulsion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Aspiration  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Dyspnoea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Pleural effusion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Pneumonia aspiration  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Respiratory distress  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Respiratory failure  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders             
Lymphoedema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY2603618 40 mg/m^2 (4.5-hour Infusion) LY2603618 40 mg/m^2 (1-hour Infusion) LY2603618 70 mg/m^2 LY2603618 105 mg/m^2 LY2603618 150 mg/m^2 LY2603618 195 mg/m^2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      13/13 (100.00%)      6/6 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders             
Anaemia  1  0/3 (0.00%)  0 1/3 (33.33%)  2 1/3 (33.33%)  4 1/13 (7.69%)  1 3/6 (50.00%)  5 1/3 (33.33%)  1
Leukopenia  1  0/3 (0.00%)  0 1/3 (33.33%)  2 1/3 (33.33%)  3 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Neutropenia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 5/13 (38.46%)  6 3/6 (50.00%)  3 1/3 (33.33%)  1
Thrombocytopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  2 1/13 (7.69%)  2 2/6 (33.33%)  2 2/3 (66.67%)  4
Cardiac disorders             
Atrial fibrillation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Sinus tachycardia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  2 1/6 (16.67%)  1 0/3 (0.00%)  0
Tachycardia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/13 (7.69%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Ventricular extrasystoles  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Ear and labyrinth disorders             
Cerumen impaction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Ear pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Tinnitus  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Vertigo  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Endocrine disorders             
Hypothyroidism  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Eye disorders             
Conjunctival pallor  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Lacrimation increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Photophobia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Vision blurred  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders             
Abdominal discomfort  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Abdominal distension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Abdominal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  2 4/13 (30.77%)  6 0/6 (0.00%)  0 1/3 (33.33%)  2
Abdominal pain upper  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Abnormal faeces  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1
Ascites  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Constipation  1  1/3 (33.33%)  2 2/3 (66.67%)  3 1/3 (33.33%)  1 2/13 (15.38%)  2 2/6 (33.33%)  3 0/3 (0.00%)  0
Diarrhoea  1  1/3 (33.33%)  1 1/3 (33.33%)  2 1/3 (33.33%)  2 5/13 (38.46%)  7 3/6 (50.00%)  3 0/3 (0.00%)  0
Dry mouth  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Dysphagia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  3 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Flatulence  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Frequent bowel movements  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal sounds abnormal  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Gastrooesophageal reflux disease  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Gingival pain  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Haematemesis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Haematochezia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Haemorrhoids  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Lip blister  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Melaena  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Nausea  1  2/3 (66.67%)  3 2/3 (66.67%)  2 3/3 (100.00%)  6 7/13 (53.85%)  12 2/6 (33.33%)  3 0/3 (0.00%)  0
Oesophageal obstruction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Proctalgia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  2 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Small intestinal obstruction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Vomiting  1  1/3 (33.33%)  1 0/3 (0.00%)  0 3/3 (100.00%)  5 5/13 (38.46%)  6 3/6 (50.00%)  4 0/3 (0.00%)  0
General disorders             
Catheter site pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Catheter site pruritus  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Chest discomfort  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Chest pain  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Chills  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/13 (0.00%)  0 2/6 (33.33%)  2 1/3 (33.33%)  2
Fatigue  1  0/3 (0.00%)  0 3/3 (100.00%)  5 3/3 (100.00%)  3 4/13 (30.77%)  5 5/6 (83.33%)  8 2/3 (66.67%)  2
General physical health deterioration  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Generalised oedema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Influenza like illness  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Malaise  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Mucosal inflammation  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  2
Oedema peripheral  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 4/13 (30.77%)  6 3/6 (50.00%)  3 0/3 (0.00%)  0
Pyrexia  1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 4/13 (30.77%)  5 2/6 (33.33%)  3 0/3 (0.00%)  0
Tenderness  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Thirst  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Hepatobiliary disorders             
Hyperbilirubinaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  5 0/6 (0.00%)  0 1/3 (33.33%)  1
Immune system disorders             
Seasonal allergy  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Infections and infestations             
Bacterial infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Candidiasis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  1
Catheter site infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Cellulitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  3 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Folliculitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1
Herpes zoster  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Oral candidiasis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 2/13 (15.38%)  2 1/6 (16.67%)  2 0/3 (0.00%)  0
Tooth infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1
Upper respiratory tract infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Urinary tract infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 3/6 (50.00%)  3 0/3 (0.00%)  0
Vulvovaginal candidiasis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Injury, poisoning and procedural complications             
Muscle strain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Investigations             
Alanine aminotransferase increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  5 1/6 (16.67%)  2 0/3 (0.00%)  0
Aspartate aminotransferase increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  4 1/6 (16.67%)  1 0/3 (0.00%)  0
Blood alkaline phosphatase increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  4 1/6 (16.67%)  1 0/3 (0.00%)  0
Blood creatinine increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 1/3 (33.33%)  1
Blood pressure diastolic increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Breath sounds abnormal  1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Cardiac murmur  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Haemoglobin decreased  1  0/3 (0.00%)  0 2/3 (66.67%)  2 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Heart rate irregular  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Lymph node palpable  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Weight decreased  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  2 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Weight increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  3 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders             
Anorexia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  2 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Dehydration  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 4/13 (30.77%)  5 1/6 (16.67%)  1 1/3 (33.33%)  1
Hyperglycaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/13 (23.08%)  3 3/6 (50.00%)  5 1/3 (33.33%)  1
Hypoalbuminaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Hypocalcaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Hypokalaemia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  2 3/13 (23.08%)  3 2/6 (33.33%)  3 0/3 (0.00%)  0
Hypomagnesaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  2 2/6 (33.33%)  2 0/3 (0.00%)  0
Hypophosphataemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1
Malnutrition  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/6 (16.67%)  1 1/3 (33.33%)  1
Metabolic acidosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Back pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/3 (66.67%)  3 1/13 (7.69%)  1 2/6 (33.33%)  2 0/3 (0.00%)  0
Bone pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Flank pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Muscle spasms  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Musculoskeletal chest pain  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 1/13 (7.69%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Musculoskeletal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Myalgia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Pain in extremity  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 2/13 (15.38%)  3 0/6 (0.00%)  0 0/3 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Malignant ascites  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Melanocytic naevus  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Nervous system disorders             
Dizziness  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 1/13 (7.69%)  3 1/6 (16.67%)  1 0/3 (0.00%)  0
Dysgeusia  1  2/3 (66.67%)  3 1/3 (33.33%)  1 2/3 (66.67%)  2 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Headache  1  1/3 (33.33%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Hypoaesthesia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Paraesthesia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Sinus headache  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Syncope  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  2 0/3 (0.00%)  0
Tremor  1  0/3 (0.00%)  0 2/3 (66.67%)  2 0/3 (0.00%)  0 2/13 (15.38%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Psychiatric disorders             
Anxiety  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Confusional state  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Depression  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Insomnia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Mental disorder  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Renal and urinary disorders             
Dysuria  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 2/13 (15.38%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Haematuria  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  1
Incontinence  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Micturition urgency  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Renal failure  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Renal failure acute  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1
Reproductive system and breast disorders             
Breast mass  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Penile swelling  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Scrotal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  2 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Scrotal swelling  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Vaginal discharge  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1
Respiratory, thoracic and mediastinal disorders             
Cough  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 2/6 (33.33%)  2 0/3 (0.00%)  0
Dysphonia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Dyspnoea  1  1/3 (33.33%)  1 1/3 (33.33%)  2 0/3 (0.00%)  0 3/13 (23.08%)  3 1/6 (16.67%)  2 0/3 (0.00%)  0
Dyspnoea exertional  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Haemoptysis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Nasal mucosal disorder  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Oropharyngeal pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Paranasal sinus hypersecretion  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Pleural effusion  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 3/6 (50.00%)  3 0/3 (0.00%)  0
Pleuritic pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Productive cough  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Rales  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 2/6 (33.33%)  2 0/3 (0.00%)  0
Respiratory failure  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Rhinorrhoea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Sinus congestion  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders             
Campbell de morgan spots  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Dry skin  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Erythema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Hyperhidrosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Night sweats  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Petechiae  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Photosensitivity reaction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Pigmentation disorder  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Pruritus  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Rash  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/13 (7.69%)  1 3/6 (50.00%)  3 0/3 (0.00%)  0
Skin exfoliation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Skin odour abnormal  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Urticaria  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders             
Flushing  1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Haematoma  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Hot flush  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Hypertension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/6 (16.67%)  2 1/3 (33.33%)  1
Jugular vein thrombosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Lymphoedema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  5 0/13 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Vena cava thrombosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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
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: NCT00415636    
Other Study ID Numbers: 11911
I2I-MC-JMMB ( Other Identifier: Eli Lilly and Company )
First Submitted: December 21, 2006
First Posted: December 25, 2006
Results First Submitted: February 17, 2018
Results First Posted: October 19, 2018
Last Update Posted: October 19, 2018