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A Study of LY3076226 in Participants With Advanced or Metastatic Cancer

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ClinicalTrials.gov Identifier: NCT02529553
Recruitment Status : Completed
First Posted : August 20, 2015
Results First Posted : April 17, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced Cancer
Metastatic Cancer
Intervention Drug: LY3076226
Enrollment 25
Recruitment Details  
Pre-assignment Details

Part A (dose escalation in advanced cancer): LY3076226 administered intravenously (IV) on day 1 of each 21 day cycle.

Part B (dose expansion in advanced urothelial carcinoma): LY3076226 administered IV on day 1 of each 21 day cycle.

Arm/Group Title LY3076226-0.2mg/kg LY3076226-0.4mg/kg LY3076226-0.8mg/kg LY3076226-1.6mg/kg LY3076226-2.4mg/kg LY3076226-3.2mg/kg LY3076226-4.0mg/kg LY3076226-5.0mg/kg LY3076226-5.0mg/kg Dose Expansion
Hide Arm/Group Description Part A cohort 1 of dose escalation of LY3076226 at 0.2 milligram per killogram (mg/kg). Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg. Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg. Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg. Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg. Part A cohort 6 of dose escalation of LY3076226 at 3.2mg/kg. Part A cohort 7 of dose escalation of LY3076226 at 4.0mg/kg. Part A cohort 8 of dose escalation of LY3076226 at 5.0mg/kg. Part B dose expansion of LY3076226 at 5.0mg/kg.
Period Title: Overall Study
Started 1 1 1 3 3 4 3 6 3
Completed 0 0 0 0 0 0 0 0 0
Not Completed 1 1 1 3 3 4 3 6 3
Reason Not Completed
Progressive Disease             1             0             1             3             2             3             3             5             3
Physician Decision             0             1             0             0             1             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             1             0             1             0
Arm/Group Title LY3076226-0.2mg/kg LY3076226-0.4mg/kg LY3076226-0.8mg/kg LY3076226-1.6mg/kg LY3076226-2.4mg/kg LY3076226-3.2mg/kg LY3076226-4.0mg/kg LY3076226-5.0mg/kg LY3076226-5.0mg/kg Dose Expansion Total
Hide Arm/Group Description Part A cohort 1 of dose escalation of LY3076226 at 0.2mg/kg. Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg. Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg. Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg. Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg. Part A cohort 6 of dose escalation of LY3076226 at 3.2mg/kg. Part A cohort 7 of dose escalation of LY3076226 at 4.0mg/kg. Part A cohort 8 of dose escalation of LY3076226 at 5.0mg/kg. Part B dose expansion of LY3076226 at 5.0mg/kg. Total of all reporting groups
Overall Number of Baseline Participants 1 1 1 3 3 4 3 6 3 25
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 1 participants 3 participants 3 participants 4 participants 3 participants 6 participants 3 participants 25 participants
41.0 73.0 56.0 68.3  (1.5) 55.0  (6.2) 63.0  (5.5) 72.7  (9.8) 65.8  (8.7) 56.3  (5.9) 63.0  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 3 participants 3 participants 4 participants 3 participants 6 participants 3 participants 25 participants
Female 0 0 0 2 2 4 2 2 1 13
Male 1 1 1 1 1 0 1 4 2 12
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 3 participants 3 participants 4 participants 3 participants 6 participants 3 participants 25 participants
Hispanic or Latino 1 0 0 1 1 1 1 1 0 6
Not Hispanic or Latino 0 1 1 2 2 3 2 5 3 19
Unknown or Not Reported 0 0 0 0 0 0 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 3 participants 3 participants 4 participants 3 participants 6 participants 3 participants 25 participants
American Indian or Alaska Native 0 0 0 0 0 0 0 0 0 0
Asian 0 0 0 0 0 0 1 1 0 2
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0 0 0 0 0
Black or African American 0 0 0 0 0 0 0 1 0 1
White 1 1 1 3 3 4 2 4 3 22
More than one race 0 0 0 0 0 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 0 0 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 3 participants 3 participants 4 participants 3 participants 6 participants 3 participants 25 participants
Canada 0 0 0 0 2 1 1 1 2 7
United States 1 1 1 3 1 3 2 5 1 18
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of LY3076226
Hide Description The MTD was defined as the highest dose tested that had less than 33% probability of causing a dose limiting toxicity (DLT).
Time Frame Cycle 1 (21 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in dose escalation.
Arm/Group Title LY3076226
Hide Arm/Group Description:
Part A dose escalation of LY3076226 administered intravenously (IV) on day 1 of cycle 1.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: milligrams
5.0
2.Secondary Outcome
Title Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226
Hide Description [Not Specified]
Time Frame Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with adequate measurable PK concentrations.
Arm/Group Title LY3076226-0.2mg/kg LY3076226-0.4mg/kg LY3076226-0.8mg/kg LY3076226-1.6mg/kg LY3076226-2.4mg/kg LY3076226-3.2mg/kg LY3076226-4.0mg/kg LY3076226-5.0mg/kg LY3076226-5.0mg/kg Dose Expansion
Hide Arm/Group Description:
Cohort 1 of dose escalation of LY3076226 at 0.2 mg/kg.
Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
Dose expansion of LY3076226 at 5.0mg/kg.
Overall Number of Participants Analyzed 1 1 1 3 3 4 3 6 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter(μg/mL)
Cycle 1 Number Analyzed 1 participants 1 participants 1 participants 3 participants 3 participants 4 participants 3 participants 6 participants 3 participants
5.35 10.6 23.3
41.9
(22.2%)
133
(123%)
77.4
(20.5%)
104
(9.37%)
119
(16.2%)
101
(22.3%)
Cycle 3 Number Analyzed 0 participants 0 participants 0 participants 0 participants 3 participants 2 participants 3 participants 4 participants 3 participants
62.0
(34.0%)
89.8
(100%)
105
(8.26%)
144
(5.60%)
95.7
(22.1%)
3.Secondary Outcome
Title PK: Area Under the Concentration-Time Curve (AUC) of LY3076226
Hide Description [Not Specified]
Time Frame Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with adequate measurable PK concentrations.
Arm/Group Title LY3076226-0.2mg/kg LY3076226-0.4mg/kg LY3076226-0.8mg/kg LY3076226-1.6mg/kg LY3076226-2.4mg/kg LY3076226-3.2mg/kg LY3076226-4.0mg/kg LY3076226-5.0mg/kg LY3076226-5.0mg/kg Dose Expansion
Hide Arm/Group Description:
Cohort 1 of dose escalation of LY3076226 at 0.2 mg/kg.
Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
Dose expansion of LY3076226 at 5.0mg/kg.
Overall Number of Participants Analyzed 1 1 1 3 3 4 3 6 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg per day per mL(μg/day/mL)
Cycle 1 Number Analyzed 1 participants 1 participants 1 participants 3 participants 3 participants 4 participants 3 participants 6 participants 3 participants
13.0 18.8 112
223
(14.3%)
503
(55.5%)
424
(33.2%)
665
(14.0%)
664
(29.5%)
638
(17.1%)
Cycle 3 Number Analyzed 0 participants 0 participants 0 participants 0 participants 3 participants 2 participants 3 participants 4 participants 3 participants
374
(78.2%)
758
(833%)
688
(41.2%)
1120
(18.9%)
801
(27.0%)
4.Secondary Outcome
Title Number of Participants With Tumor Response
Hide Description Tumor response was assessed using confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). Complete response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; partial response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions.
Time Frame Baseline through Study Completion (Cycle 3, day 21)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title LY3076226-0.2mg/kg LY3076226-0.4mg/kg LY3076226-0.8mg/kg LY3076226-1.6mg/kg LY3076226-2.4mg/kg LY3076226-3.2mg/kg LY3076226-4.0mg/kg LY3076226-5.0mg/kg LY3076226-5.0mg/kg Dose Expansion
Hide Arm/Group Description:
Cohort 1 of dose escalation of LY3076226 at 0.2 mg/kg.
Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
Dose expansion of LY3076226 at 5.0mg/kg.
Overall Number of Participants Analyzed 1 1 1 3 3 4 3 6 3
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0 0 0 0 0
Time Frame Up To 33 Days post study treatment
Adverse Event Reporting Description All participants who received at least one dose of study drug.
 
Arm/Group Title LY3076226-0.2mg/kg LY3076226-0.4mg/kg LY3076226-0.8mg/kg LY3076226-1.6mg/kg LY3076226-2.4mg/kg LY3076226-3.2mg/kg LY3076226-4.0mg/kg LY3076226-5.0mg/kg LY3076226-5.0mg/kg Dose Expansion
Hide Arm/Group Description Part A cohort 1 of dose escalation of LY3076226 at 0.2mg/kg. Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg. Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg. Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg. Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg. Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg. Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg. Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg. Part B dose expansion of LY3076226 at 5.0mg/kg.
All-Cause Mortality
LY3076226-0.2mg/kg LY3076226-0.4mg/kg LY3076226-0.8mg/kg LY3076226-1.6mg/kg LY3076226-2.4mg/kg LY3076226-3.2mg/kg LY3076226-4.0mg/kg LY3076226-5.0mg/kg LY3076226-5.0mg/kg Dose Expansion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/4 (0.00%)      0/3 (0.00%)      0/6 (0.00%)      0/3 (0.00%)    
Hide Serious Adverse Events
LY3076226-0.2mg/kg LY3076226-0.4mg/kg LY3076226-0.8mg/kg LY3076226-1.6mg/kg LY3076226-2.4mg/kg LY3076226-3.2mg/kg LY3076226-4.0mg/kg LY3076226-5.0mg/kg LY3076226-5.0mg/kg Dose Expansion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   0/1 (0.00%)      1/1 (100.00%)      0/1 (0.00%)      1/3 (33.33%)      1/3 (33.33%)      0/4 (0.00%)      0/3 (0.00%)      1/6 (16.67%)      0/3 (0.00%)    
Gastrointestinal disorders                   
Small intestinal obstruction  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations                   
Kidney infection  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Injury, poisoning and procedural complications                   
Fall  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders                   
Hypokalaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Renal and urinary disorders                   
Acute kidney injury  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LY3076226-0.2mg/kg LY3076226-0.4mg/kg LY3076226-0.8mg/kg LY3076226-1.6mg/kg LY3076226-2.4mg/kg LY3076226-3.2mg/kg LY3076226-4.0mg/kg LY3076226-5.0mg/kg LY3076226-5.0mg/kg Dose Expansion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   1/1 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      4/4 (100.00%)      3/3 (100.00%)      6/6 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders                   
Anaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/3 (33.33%)  1
Cardiac disorders                   
Atrial fibrillation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Sinus bradycardia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Sinus tachycardia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Eye disorders                   
Corneal epithelial microcysts  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1
Dry eye  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Keratitis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Photopsia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Retinal pigment epitheliopathy  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Vision blurred  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  2 0/4 (0.00%)  0 1/3 (33.33%)  2 1/6 (16.67%)  1 0/3 (0.00%)  0
Gastrointestinal disorders                   
Abdominal distension  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Abdominal pain  1  0/1 (0.00%)  0 1/1 (100.00%)  1 1/1 (100.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  2 1/6 (16.67%)  1 0/3 (0.00%)  0
Ascites  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Constipation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2 0/3 (0.00%)  0
Diarrhoea  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  3 1/4 (25.00%)  1 3/3 (100.00%)  6 4/6 (66.67%)  4 0/3 (0.00%)  0
Dry mouth  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Dysphagia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Eructation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Gastritis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Gastrooesophageal reflux disease  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  2 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Nausea  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/3 (66.67%)  3 3/3 (100.00%)  3 2/4 (50.00%)  2 0/3 (0.00%)  0 2/6 (33.33%)  2 2/3 (66.67%)  8
Oesophageal pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Rectal discharge  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Rectal haemorrhage  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Stomatitis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Vomiting  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  2
General disorders                   
Chest discomfort  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Chills  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  2 1/6 (16.67%)  2 0/3 (0.00%)  0
Early satiety  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Fatigue  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/3 (66.67%)  2 1/3 (33.33%)  1 2/4 (50.00%)  2 3/3 (100.00%)  4 0/6 (0.00%)  0 2/3 (66.67%)  3
Non-cardiac chest pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Oedema peripheral  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Pyrexia  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations                   
Cystitis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1 1/3 (33.33%)  1
Nasal vestibulitis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Oral candidiasis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Pharyngitis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Sepsis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Skin infection  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Urinary tract infection  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 0/3 (0.00%)  0
Injury, poisoning and procedural complications                   
Fall  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Ligament sprain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Thermal burn  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Investigations                   
Alanine aminotransferase increased  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Aspartate aminotransferase increased  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 3/6 (50.00%)  3 1/3 (33.33%)  1
Blood alkaline phosphatase increased  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 2/3 (66.67%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  2
Blood bilirubin increased  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Blood creatinine increased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Platelet count decreased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2 2/3 (66.67%)  3
Weight decreased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders                   
Decreased appetite  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 2/3 (66.67%)  2 1/6 (16.67%)  2 1/3 (33.33%)  2
Dehydration  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Hypercalcaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  1
Hyperglycaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Hyperkalaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Hypoalbuminaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 0/3 (0.00%)  0
Hypokalaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Hypomagnesaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Hyponatraemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Hypophosphataemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Arthritis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 0/3 (0.00%)  0
Back pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Muscular weakness  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Musculoskeletal chest pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Myalgia  1  0/1 (0.00%)  0 1/1 (100.00%)  1 1/1 (100.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Pain in extremity  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Tumour pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1
Nervous system disorders                   
Dysaesthesia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Dysgeusia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Headache  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  2 0/4 (0.00%)  0 2/3 (66.67%)  3 1/6 (16.67%)  2 0/3 (0.00%)  0
Neuralgia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Paraesthesia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1
Peripheral motor neuropathy  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Peripheral sensory neuropathy  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 1/6 (16.67%)  2 1/3 (33.33%)  1
Spinal cord compression  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Syncope  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Tremor  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Psychiatric disorders                   
Anxiety  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Confusional state  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Depression  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Renal and urinary disorders                   
Acute kidney injury  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Chromaturia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Haematuria  1  0/1 (0.00%)  0 1/1 (100.00%)  2 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Urinary retention  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
Cough  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Dysphonia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  1
Dyspnoea  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/3 (33.33%)  1
Hiccups  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Nasal congestion  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Oropharyngeal pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Pleural effusion  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/3 (66.67%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Productive cough  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Pulmonary haemorrhage  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1
Rhinitis allergic  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Upper-airway cough syndrome  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Wheezing  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Dermatitis contact  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Dry skin  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1
Hyperhidrosis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Photosensitivity reaction  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0
Pruritus  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Rash maculo-papular  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/3 (66.67%)  2 1/6 (16.67%)  1 0/3 (0.00%)  0
Skin hyperpigmentation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders                   
Embolism  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Hot flush  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0
Hypertension  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  3 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Due to pipeline reprioritization, development of LY3076226 was discontinued at the end of 2017 and no further patients were enrolled.
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
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02529553    
Other Study ID Numbers: 15383
I7O-MC-JOBA ( Other Identifier: Eli Lilly and Company )
First Submitted: August 19, 2015
First Posted: August 20, 2015
Results First Submitted: March 8, 2020
Results First Posted: April 17, 2020
Last Update Posted: April 17, 2020