Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 16 for:    "Acute T Cell Leukemia" | "Dexamethasone acetate"
Previous Study | Return to List | Next Study

A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518113
Recruitment Status : Completed
First Posted : August 7, 2015
Results First Posted : February 6, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions T-cell Acute Lymphoblastic Leukemia
T-cell Lymphoblastic Lymphoma
Interventions Drug: LY3039478
Drug: Dexamethasone
Drug: Placebo
Enrollment 36
Recruitment Details  
Pre-assignment Details Study completers are those participants that completed Part A cycle 1 or experienced a DLT. There were no participants enrolled to Part B and Phase 2 of the study.
Arm/Group Title 50 mg LY3039478 + Dexamethasone 75 mg LY3039478 + Dexamethasone 100 mg LY3039478 + Dexamethasone 125 mg LY3039478 + Dexamethasone
Hide Arm/Group Description Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression. Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression. Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression. Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Period Title: Overall Study
Started 6 12 15 3
Completed 3 7 11 3
Not Completed 3 5 4 0
Reason Not Completed
Adverse Event             1             0             1             0
Death             1             2             0             0
Physician Decision             0             1             0             0
Progressive Disease             1             2             3             0
Arm/Group Title 50 mg LY3039478 + Dexamethasone 75 mg LY3039478 + Dexamethasone 100 mg LY3039478 + Dexamethasone 125 mg LY3039478 + Dexamethasone Total
Hide Arm/Group Description Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression. Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression. Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression. Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression. Total of all reporting groups
Overall Number of Baseline Participants 6 12 15 3 36
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 12 participants 15 participants 3 participants 36 participants
38.83  (12.22) 36.42  (13.40) 45.87  (14.41) 26.67  (10.69) 39.94  (14.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 12 participants 15 participants 3 participants 36 participants
Female 0 5 5 1 11
Male 6 7 10 2 25
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 12 participants 15 participants 3 participants 36 participants
Hispanic or Latino 1 1 1 1 4
Not Hispanic or Latino 4 8 11 2 25
Unknown or Not Reported 1 3 3 0 7
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 12 participants 15 participants 3 participants 36 participants
American Indian or Alaska Native 0 0 0 0 0
Asian 0 1 0 0 1
Native Hawaiian or Other Pacific Islander 0 0 0 0 0
Black or African American 0 1 1 0 2
White 5 10 12 3 30
More than one race 0 0 0 0 0
Unknown or Not Reported 1 0 2 0 3
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 12 participants 15 participants 3 participants 36 participants
United States 2 7 7 1 17
Italy 0 0 2 2 4
France 3 4 4 0 11
Germany 1 1 2 0 4
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities (DLTs)
Hide Description A DLT was an Adverse Event(AE) observed during the first 28 day cycle that is determined by the investigator to be at least possibly related to LY3039478 according to CTCAE v 4.0 and fulfills any of the following criteria: CTCAE Grade 3 nonhematological toxicity with a few exceptions, any other significant toxicity deemed to be dose limiting (eg, any toxicity that is possibly related to the study medication that requires the withdrawal of the patient from the study during Cycle 1).
Time Frame Cycle 1 (Up To 28 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug in Part A.
Arm/Group Title 50 mg LY3039478 + Dexamethasone 75 mg LY3039478 + Dexamethasone 100 mg LY3039478 + Dexamethasone 125 mg LY3039478 + Dexamethasone
Hide Arm/Group Description:
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Overall Number of Participants Analyzed 6 12 15 3
Measure Type: Count of Participants
Unit of Measure: Participants
0 2 2 3
2.Primary Outcome
Title Recommended Dose of LY3039478 in Combination With Dexamethasone
Hide Description A DLT was an Adverse Event(AE) observed during the first 28 day cycle that is determined by the investigator to be at least possibly related to LY3039478 according to CTCAE v 4.0 and fulfills any of the following criteria:CTCAE Grade 3 nonhematological toxicity with a few exceptions, any other significant toxicity deemed to be dose limiting.A dose-limiting equivalent toxicity (DLET) was defined as an AE occurring between Day 1 and Day 28 of any cycle (other than Cycle 1) for a patient enrolled in the Phase 1 portion or in any cycle (including Cycle 1) for a patient enrolled in the Phase 2 portion that would have met the criteria for DLT if it had occurred during Cycle 1 for a patient enrolled in the Phase 1 portion.
Time Frame Cycle 1 (28 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug in Part A.
Arm/Group Title All Participants
Hide Arm/Group Description:

Part A:

50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: mg
75
3.Primary Outcome
Title Number of Participants Who Achieve Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi): Overall Remission Rate (ORR)
Hide Description ORR is defined as the number of participants who achieved a best overall response of either complete remission (CR) or incomplete remission (CRi). The ORR (CR and CRi) is the sum of patients achieving a CR or a CRi divided by the total number of patients randomized in that arm. CR is defined as the number of participants who achieved a best overall response of complete remission (CR), out of the total number of participants randomized in that arm.
Time Frame Baseline to Objective Disease Progression (Up To 2 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug in Part A.
Arm/Group Title 50 mg LY3039478 + Dexamethasone 75 mg LY3039478 + Dexamethasone 100 mg LY3039478 + Dexamethasone 125 mg LY3039478 + Dexamethasone
Hide Arm/Group Description:
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Overall Number of Participants Analyzed 6 12 15 3
Measure Type: Count of Participants
Unit of Measure: Participants
1 0 0 0
4.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination With Dexamethasone in Day 1
Hide Description Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination with Dexamethasone in Day 1
Time Frame Cycle 1 Day 1: Predose, 1-2, 3-4,6-8,24-30 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug in Part A and had evaluable PK data.
Arm/Group Title 50 mg LY3039478 + Dexamethasone 75 mg LY3039478 + Dexamethasone 100 mg LY3039478 + Dexamethasone 125 mg LY3039478 + Dexamethasone
Hide Arm/Group Description:
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Overall Number of Participants Analyzed 5 12 15 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram hour per milliliter (ng*h/mL)
3480
(26%)
5000
(45%)
5870
(49%)
6330 [1] 
(NA%)
[1]
For n=2, range 3180-12600 was reported.
5.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0- 48]) of LY3039478 in Combination With Dexamethasone in Day 8
Hide Description Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0- 48]) of LY3039478 in Combination with Dexamethasone in Day 8
Time Frame Cycle 1 Day 8: Predose, 1-2, 3-4,6-8,24-30 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug in Part A and had evaluable PK data.
Arm/Group Title 50 mg LY3039478 + Dexamethasone 75 mg LY3039478 + Dexamethasone 100 mg LY3039478 + Dexamethasone 125 mg LY3039478 + Dexamethasone
Hide Arm/Group Description:
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Overall Number of Participants Analyzed 5 8 12 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
3050
(18%)
4070
(92%)
4640
(55%)
8240 [1] 
(NA%)
[1]
For n=2, range 4410-16100 was reported.
6.Secondary Outcome
Title Number of Participants With CR or CRi and Notch-1 or FBXW7 Mutations
Hide Description ORR is defined as the number of participants who achieved a best overall response of either complete remission (CR) or incomplete remission (CRi). The ORR (CR and CRi) is the sum of participants achieving a CR or a CRi divided by the total number of participants randomized in that arm. CR is defined as the number of participants who achieved a best overall response of complete remission (CR), out of the total number of participants randomized in that arm.
Time Frame Baseline to Objective Disease Progression (Up To 12 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug in Part A.
Arm/Group Title 50 mg LY3039478 + Dexamethasone 75 mg LY3039478 + Dexamethasone 100 mg LY3039478 + Dexamethasone 125 mg LY3039478 + Dexamethasone
Hide Arm/Group Description:
Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Overall Number of Participants Analyzed 6 12 15 3
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0 0
7.Secondary Outcome
Title Phase 2: Number of Participants Who Achieve CR, CRi or Partial Remission (PR): Overall Remission Rate (ORR) Plus PR
Hide Description [Not Specified]
Time Frame Baseline to Objective Disease Progression (Up To 12 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Arm/Group Title LY3039478 + Dexamethasone Placebo + Dexamethasone
Hide Arm/Group Description:
LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Placebo administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Phase 2: Number of Participants Who Achieve PR
Hide Description [Not Specified]
Time Frame Baseline to Objective Disease Progression (Up To 12 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Arm/Group Title LY3039478 + Dexamethasone Placebo + Dexamethasone
Hide Arm/Group Description:
LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Placebo administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Phase 2: Duration of Remission (DoR)
Hide Description [Not Specified]
Time Frame Date of CR, CRi, or PR to Date of Relapse or Death from Any Cause (Approximately 1 Year)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Arm/Group Title LY3039478 + Dexamethasone Placebo + Dexamethasone
Hide Arm/Group Description:
LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Placebo administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Phase 2:Relapse Free Survival (RFS)
Hide Description [Not Specified]
Time Frame Date of CR to Relapse or Death from any Cause (Approximately 1 Year)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Arm/Group Title LY3039478 + Dexamethasone Placebo + Dexamethasone
Hide Arm/Group Description:
LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Placebo administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Phase 2: Event Free Survival (EFS)
Hide Description [Not Specified]
Time Frame Baseline to Objective Disease Progression or Death from Any Cause (Approximately 1 Year)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Arm/Group Title LY3039478 + Dexamethasone Placebo + Dexamethasone
Hide Arm/Group Description:
LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Placebo administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Phase 2: Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Baseline to the Date of Death from Any Cause (Approximately 1.5 Years)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Arm/Group Title LY3039478 + Dexamethasone Placebo + Dexamethasone
Hide Arm/Group Description:
LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Placebo administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Phase 2: Change From Baseline in the Functional Assessment of Cancer Therapy-Leukemia-General (FACT-Leu-G) Score
Hide Description [Not Specified]
Time Frame Baseline, End of Study (Approximately 1.5 Years)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.
Arm/Group Title LY3039478 + Dexamethasone Placebo + Dexamethasone
Hide Arm/Group Description:
LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Placebo administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up To 16 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 50 mg LY3039478 + Dexamethasone 75 mg LY3039478 + Dexamethasone 100 mg LY3039478 + Dexamethasone 125 mg LY3039478 + Dexamethasone
Hide Arm/Group Description Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression. Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression. Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression
All-Cause Mortality
50 mg LY3039478 + Dexamethasone 75 mg LY3039478 + Dexamethasone 100 mg LY3039478 + Dexamethasone 125 mg LY3039478 + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)      8/12 (66.67%)      12/15 (80.00%)      2/3 (66.67%)    
Show Serious Adverse Events Hide Serious Adverse Events
50 mg LY3039478 + Dexamethasone 75 mg LY3039478 + Dexamethasone 100 mg LY3039478 + Dexamethasone 125 mg LY3039478 + Dexamethasone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      11/12 (91.67%)      9/15 (60.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders         
Anaemia  1  0/6 (0.00%)  0 2/12 (16.67%)  2 0/15 (0.00%)  0 0/3 (0.00%)  0
Febrile neutropenia  1  1/6 (16.67%)  1 1/12 (8.33%)  2 0/15 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders         
Colitis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Diarrhoea  1  1/6 (16.67%)  2 2/12 (16.67%)  3 2/15 (13.33%)  4 1/3 (33.33%)  5
Gastric ulcer  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal haemorrhage  1  0/6 (0.00%)  0 2/12 (16.67%)  3 0/15 (0.00%)  0 0/3 (0.00%)  0
Ileus  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Intestinal obstruction  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Nausea  1  0/6 (0.00%)  0 1/12 (8.33%)  1 1/15 (6.67%)  2 0/3 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Vomiting  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
General disorders         
Fatigue  1  0/6 (0.00%)  0 2/12 (16.67%)  2 0/15 (0.00%)  0 0/3 (0.00%)  0
Non-cardiac chest pain  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Pain  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Pyrexia  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Infections and infestations         
Atypical pneumonia  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Bacteraemia  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Device related infection  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
H1n1 influenza  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Infection  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Lung infection  1  0/6 (0.00%)  0 1/12 (8.33%)  1 1/15 (6.67%)  1 1/3 (33.33%)  1
Neutropenic infection  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Perirectal abscess  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  2
Pneumonia  1  1/6 (16.67%)  1 2/12 (16.67%)  2 2/15 (13.33%)  2 0/3 (0.00%)  0
Sepsis  1  0/6 (0.00%)  0 1/12 (8.33%)  2 0/15 (0.00%)  0 0/3 (0.00%)  0
Septic shock  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 1/3 (33.33%)  1
Upper respiratory tract infection  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Injury, poisoning and procedural complications         
Overdose  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Investigations         
Lipase increased  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Weight decreased  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration  1  0/6 (0.00%)  0 3/12 (25.00%)  3 2/15 (13.33%)  3 1/3 (33.33%)  1
Failure to thrive  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Hypokalaemia  1  0/6 (0.00%)  0 1/12 (8.33%)  3 1/15 (6.67%)  1 1/3 (33.33%)  1
Tumour lysis syndrome  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Muscular weakness  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Nasopharyngeal cancer  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders         
Generalised tonic-clonic seizure  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Haemorrhage intracranial  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Syncope  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Renal and urinary disorders         
Acute kidney injury  1  0/6 (0.00%)  0 1/12 (8.33%)  2 0/15 (0.00%)  0 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Aspiration  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Dyspnoea  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Hypoxia  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Respiratory failure  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders         
Hypotension  1  1/6 (16.67%)  1 3/12 (25.00%)  3 0/15 (0.00%)  0 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
50 mg LY3039478 + Dexamethasone 75 mg LY3039478 + Dexamethasone 100 mg LY3039478 + Dexamethasone 125 mg LY3039478 + Dexamethasone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      12/12 (100.00%)      15/15 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders         
Anaemia  1  3/6 (50.00%)  4 2/12 (16.67%)  3 3/15 (20.00%)  4 1/3 (33.33%)  1
Febrile neutropenia  1  1/6 (16.67%)  1 0/12 (0.00%)  0 1/15 (6.67%)  1 1/3 (33.33%)  1
Immune thrombocytopenic purpura  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Increased tendency to bruise  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Leukocytosis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 2/15 (13.33%)  4 0/3 (0.00%)  0
Thrombocytopenia  1  1/6 (16.67%)  2 1/12 (8.33%)  1 2/15 (13.33%)  2 0/3 (0.00%)  0
Cardiac disorders         
Atrial fibrillation  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Bradycardia  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  2 0/3 (0.00%)  0
Cardiac failure congestive  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Pericardial effusion  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Sinus bradycardia  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Sinus tachycardia  1  0/6 (0.00%)  0 1/12 (8.33%)  1 1/15 (6.67%)  1 1/3 (33.33%)  1
Supraventricular tachycardia  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Tachycardia  1  0/6 (0.00%)  0 2/12 (16.67%)  2 3/15 (20.00%)  3 0/3 (0.00%)  0
Ventricular fibrillation  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Ventricular tachycardia  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Ear and labyrinth disorders         
Ear pain  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Hypoacusis  1  1/6 (16.67%)  1 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Tinnitus  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Endocrine disorders         
Adrenal insufficiency  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Diabetes insipidus  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Eye disorders         
Exophthalmos  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Eye pain  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Ocular hyperaemia  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Periorbital oedema  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Photophobia  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Vision blurred  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Vitritis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Gastrointestinal disorders         
Abdominal discomfort  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Abdominal distension  1  2/6 (33.33%)  2 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Abdominal pain  1  1/6 (16.67%)  1 1/12 (8.33%)  1 3/15 (20.00%)  3 0/3 (0.00%)  0
Abdominal pain upper  1  0/6 (0.00%)  0 0/12 (0.00%)  0 2/15 (13.33%)  2 1/3 (33.33%)  1
Colitis  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Constipation  1  0/6 (0.00%)  0 1/12 (8.33%)  1 4/15 (26.67%)  4 1/3 (33.33%)  1
Diarrhoea  1  3/6 (50.00%)  3 7/12 (58.33%)  20 8/15 (53.33%)  19 2/3 (66.67%)  6
Dry mouth  1  0/6 (0.00%)  0 0/12 (0.00%)  0 3/15 (20.00%)  3 0/3 (0.00%)  0
Dyspepsia  1  0/6 (0.00%)  0 2/12 (16.67%)  2 2/15 (13.33%)  2 0/3 (0.00%)  0
Dysphagia  1  2/6 (33.33%)  2 1/12 (8.33%)  1 1/15 (6.67%)  1 0/3 (0.00%)  0
Eructation  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Flatulence  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Gastric haemorrhage  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal haemorrhage  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Gastrooesophageal reflux disease  1  1/6 (16.67%)  1 0/12 (0.00%)  0 1/15 (6.67%)  1 1/3 (33.33%)  1
Gingival bleeding  1  0/6 (0.00%)  0 1/12 (8.33%)  1 1/15 (6.67%)  1 0/3 (0.00%)  0
Haematemesis  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Haematochezia  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Haemorrhoids  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Ileus  1  0/6 (0.00%)  0 1/12 (8.33%)  1 1/15 (6.67%)  1 1/3 (33.33%)  1
Lip dry  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Mouth haemorrhage  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Nausea  1  1/6 (16.67%)  1 5/12 (41.67%)  8 5/15 (33.33%)  6 3/3 (100.00%)  8
Oesophagitis  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Pancreatitis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Proctalgia  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Proctitis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 2/15 (13.33%)  2 0/3 (0.00%)  0
Rectal haemorrhage  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Stomatitis  1  1/6 (16.67%)  1 0/12 (0.00%)  0 3/15 (20.00%)  3 0/3 (0.00%)  0
Toothache  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Vomiting  1  2/6 (33.33%)  2 3/12 (25.00%)  4 8/15 (53.33%)  8 3/3 (100.00%)  9
General disorders         
Asthenia  1  0/6 (0.00%)  0 3/12 (25.00%)  5 3/15 (20.00%)  3 0/3 (0.00%)  0
Chest pain  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Chills  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Complication associated with device  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Face oedema  1  0/6 (0.00%)  0 1/12 (8.33%)  1 1/15 (6.67%)  1 0/3 (0.00%)  0
Fatigue  1  0/6 (0.00%)  0 3/12 (25.00%)  3 6/15 (40.00%)  10 2/3 (66.67%)  8
Malaise  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Mucosal inflammation  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Multiple organ dysfunction syndrome  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Non-cardiac chest pain  1  0/6 (0.00%)  0 1/12 (8.33%)  1 2/15 (13.33%)  2 1/3 (33.33%)  1
Oedema peripheral  1  2/6 (33.33%)  2 1/12 (8.33%)  3 2/15 (13.33%)  2 0/3 (0.00%)  0
Pyrexia  1  2/6 (33.33%)  2 3/12 (25.00%)  4 4/15 (26.67%)  4 1/3 (33.33%)  1
Hepatobiliary disorders         
Hepatomegaly  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Immune system disorders         
Hypersensitivity  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations         
Bacteraemia  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Bronchitis  1  0/6 (0.00%)  0 2/12 (16.67%)  2 1/15 (6.67%)  1 0/3 (0.00%)  0
Bronchopulmonary aspergillosis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Candida infection  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Cellulitis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Clostridium difficile colitis  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Clostridium difficile infection  1  0/6 (0.00%)  0 2/12 (16.67%)  3 1/15 (6.67%)  1 0/3 (0.00%)  0
Conjunctivitis  1  1/6 (16.67%)  2 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Corona virus infection  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Cytomegalovirus infection  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Dermatophytosis  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Enterococcal infection  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Epstein-barr virus infection  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Folliculitis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Gastroenteritis norovirus  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Hordeolum  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Infective glossitis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Influenza  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Lung infection  1  1/6 (16.67%)  2 0/12 (0.00%)  0 2/15 (13.33%)  2 0/3 (0.00%)  0
Mucosal infection  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Nasopharyngitis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Oral candidiasis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Pharyngitis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Pneumonia  1  0/6 (0.00%)  0 1/12 (8.33%)  1 1/15 (6.67%)  1 0/3 (0.00%)  0
Pneumonia cytomegaloviral  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Pneumonia fungal  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Pseudomonas infection  1  0/6 (0.00%)  0 1/12 (8.33%)  2 0/15 (0.00%)  0 0/3 (0.00%)  0
Rhinitis  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Rhinovirus infection  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 1/3 (33.33%)  1
Sepsis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Septic encephalopathy  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Sinusitis  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Staphylococcal infection  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Tonsillitis  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Upper respiratory tract infection  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Urinary tract infection  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Injury, poisoning and procedural complications         
Contusion  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Fall  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Muscle strain  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Overdose  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  2/6 (33.33%)  2 2/12 (16.67%)  4 3/15 (20.00%)  5 1/3 (33.33%)  2
Amylase increased  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  2 0/3 (0.00%)  0
Aspartate aminotransferase increased  1  1/6 (16.67%)  1 2/12 (16.67%)  6 4/15 (26.67%)  8 1/3 (33.33%)  3
Blood bilirubin increased  1  1/6 (16.67%)  1 1/12 (8.33%)  1 2/15 (13.33%)  4 0/3 (0.00%)  0
Blood creatinine increased  1  1/6 (16.67%)  1 1/12 (8.33%)  1 1/15 (6.67%)  1 0/3 (0.00%)  0
Blood glucose increased  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Blood lactate dehydrogenase increased  1  0/6 (0.00%)  0 1/12 (8.33%)  1 1/15 (6.67%)  3 0/3 (0.00%)  0
Blood phosphorus increased  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
C-reactive protein increased  1  1/6 (16.67%)  1 0/12 (0.00%)  0 1/15 (6.67%)  5 0/3 (0.00%)  0
Chest x-ray abnormal  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Gamma-glutamyltransferase increased  1  1/6 (16.67%)  1 0/12 (0.00%)  0 1/15 (6.67%)  2 1/3 (33.33%)  5
Immunoglobulins decreased  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Lipase increased  1  1/6 (16.67%)  2 2/12 (16.67%)  8 4/15 (26.67%)  8 0/3 (0.00%)  0
Platelet count decreased  1  1/6 (16.67%)  1 1/12 (8.33%)  1 2/15 (13.33%)  9 0/3 (0.00%)  0
Weight decreased  1  1/6 (16.67%)  2 1/12 (8.33%)  1 0/15 (0.00%)  0 1/3 (33.33%)  1
Weight increased  1  0/6 (0.00%)  0 1/12 (8.33%)  3 0/15 (0.00%)  0 0/3 (0.00%)  0
White blood cell count decreased  1  1/6 (16.67%)  6 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  1/6 (16.67%)  1 2/12 (16.67%)  3 5/15 (33.33%)  5 0/3 (0.00%)  0
Dehydration  1  1/6 (16.67%)  1 1/12 (8.33%)  1 1/15 (6.67%)  1 0/3 (0.00%)  0
Fluid overload  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Hyperglycaemia  1  2/6 (33.33%)  4 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Hyperkalaemia  1  0/6 (0.00%)  0 1/12 (8.33%)  1 2/15 (13.33%)  3 0/3 (0.00%)  0
Hypernatraemia  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  4 0/3 (0.00%)  0
Hyperphosphataemia  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Hyperuricaemia  1  0/6 (0.00%)  0 2/12 (16.67%)  2 0/15 (0.00%)  0 0/3 (0.00%)  0
Hypoalbuminaemia  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 1/3 (33.33%)  1
Hypocalcaemia  1  0/6 (0.00%)  0 1/12 (8.33%)  2 5/15 (33.33%)  7 0/3 (0.00%)  0
Hypokalaemia  1  2/6 (33.33%)  2 3/12 (25.00%)  5 8/15 (53.33%)  14 0/3 (0.00%)  0
Hypomagnesaemia  1  2/6 (33.33%)  2 2/12 (16.67%)  8 2/15 (13.33%)  3 0/3 (0.00%)  0
Hyponatraemia  1  1/6 (16.67%)  1 1/12 (8.33%)  1 1/15 (6.67%)  1 0/3 (0.00%)  0
Hypophosphataemia  1  1/6 (16.67%)  1 0/12 (0.00%)  0 4/15 (26.67%)  4 1/3 (33.33%)  5
Hypoproteinaemia  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Hypouricaemia  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Lactic acidosis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Malnutrition  1  0/6 (0.00%)  0 1/12 (8.33%)  1 1/15 (6.67%)  1 0/3 (0.00%)  0
Tumour lysis syndrome  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/6 (0.00%)  0 1/12 (8.33%)  2 2/15 (13.33%)  2 0/3 (0.00%)  0
Back pain  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Bone pain  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Muscle spasms  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Muscular weakness  1  1/6 (16.67%)  1 1/12 (8.33%)  1 1/15 (6.67%)  1 0/3 (0.00%)  0
Musculoskeletal pain  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Myalgia  1  0/6 (0.00%)  0 1/12 (8.33%)  1 1/15 (6.67%)  1 0/3 (0.00%)  0
Pain in extremity  1  1/6 (16.67%)  1 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Nervous system disorders         
Ageusia  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Aphonia  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Depressed level of consciousness  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Dizziness  1  0/6 (0.00%)  0 1/12 (8.33%)  1 1/15 (6.67%)  1 0/3 (0.00%)  0
Dysgeusia  1  1/6 (16.67%)  1 0/12 (0.00%)  0 2/15 (13.33%)  2 0/3 (0.00%)  0
Headache  1  1/6 (16.67%)  2 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Lethargy  1  1/6 (16.67%)  1 1/12 (8.33%)  1 1/15 (6.67%)  1 0/3 (0.00%)  0
Metabolic encephalopathy  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Seizure  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Syncope  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 1/3 (33.33%)  1
Psychiatric disorders         
Anxiety  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Depressed mood  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Depression  1  0/6 (0.00%)  0 1/12 (8.33%)  1 2/15 (13.33%)  2 0/3 (0.00%)  0
Dysphoria  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Insomnia  1  0/6 (0.00%)  0 1/12 (8.33%)  1 4/15 (26.67%)  5 0/3 (0.00%)  0
Mental disorder  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Renal and urinary disorders         
Acute kidney injury  1  2/6 (33.33%)  2 2/12 (16.67%)  2 1/15 (6.67%)  1 0/3 (0.00%)  0
Dysuria  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Urinary retention  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure  1  0/6 (0.00%)  0 1/12 (8.33%)  1 1/15 (6.67%)  1 0/3 (0.00%)  0
Cough  1  3/6 (50.00%)  3 1/12 (8.33%)  1 6/15 (40.00%)  6 0/3 (0.00%)  0
Dysphonia  1  1/6 (16.67%)  1 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Dyspnoea  1  1/6 (16.67%)  1 2/12 (16.67%)  2 3/15 (20.00%)  3 0/3 (0.00%)  0
Epistaxis  1  3/6 (50.00%)  3 1/12 (8.33%)  1 4/15 (26.67%)  4 1/3 (33.33%)  2
Hiccups  1  0/6 (0.00%)  0 0/12 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1
Hypoxia  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Nasal congestion  1  1/6 (16.67%)  1 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Oropharyngeal pain  1  2/6 (33.33%)  2 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Pleural effusion  1  0/6 (0.00%)  0 0/12 (0.00%)  0 2/15 (13.33%)  3 0/3 (0.00%)  0
Pneumonitis  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Productive cough  1  0/6 (0.00%)  0 1/12 (8.33%)  2 1/15 (6.67%)  1 0/3 (0.00%)  0
Pulmonary fibrosis  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Pulmonary oedema  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Respiratory failure  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Rhinitis allergic  1  1/6 (16.67%)  1 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Sinus congestion  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Tachypnoea  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Wheezing  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders         
Alopecia  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Dermatitis acneiform  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Dermatitis allergic  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Dry skin  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Ecchymosis  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Erythema  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Hand dermatitis  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Night sweats  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Pruritus  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Rash  1  0/6 (0.00%)  0 2/12 (16.67%)  2 0/15 (0.00%)  0 0/3 (0.00%)  0
Rash maculo-papular  1  1/6 (16.67%)  1 2/12 (16.67%)  2 1/15 (6.67%)  3 0/3 (0.00%)  0
Scab  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
Skin ulcer  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Vascular disorders         
Flushing  1  0/6 (0.00%)  0 0/12 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0
Hypertension  1  1/6 (16.67%)  1 0/12 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0
Hypotension  1  2/6 (33.33%)  2 1/12 (8.33%)  1 2/15 (13.33%)  2 0/3 (0.00%)  0
Peripheral artery thrombosis  1  0/6 (0.00%)  0 1/12 (8.33%)  1 0/15 (0.00%)  0 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
There were no participants enrolled to Part B and Phase 2 of the study.
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: NCT02518113     History of Changes
Other Study ID Numbers: 14548
I6F-MC-JJCB ( Other Identifier: Eli Lilly and Company )
2014-005024-10 ( EudraCT Number )
First Submitted: August 5, 2015
First Posted: August 7, 2015
Results First Submitted: January 14, 2019
Results First Posted: February 6, 2019
Last Update Posted: September 11, 2019