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Clinical Trial Results:
A Phase 1b/Randomized Phase 2 Study to Evaluate LY3039478 in Combination with Dexamethasone in T-ALL/T-LBL Patients

Summary
EudraCT number	2014-005024-10
Trial protocol	DE SE IT
Global end of trial date	15 Jan 2018

Results information
Results version number	v1(current)
This version publication date	09 Feb 2019
First version publication date	09 Feb 2019
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

I6F-MC-JJCB

ISRCTN number

US NCT number

NCT02518113

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 14548

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

15 Jan 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

15 Jan 2018

Was the trial ended prematurely?

Main objective of the trial

Phase1: to determine the recommended dose of LY3039478 in combination with dexamethasone in adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) (Part A) and pediatric patients (Part B) Phase2: to determine if the overall remission rate (ORR) (CR plus CR with incomplete blood count recovery [CRi]) in adult patients with relapsed/refractory T-ALL/T-LBL treated with LY3039478 in combination with dexamethasone exceeds that of those patients treated with placebo in combination with dexamethasone

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Oct 2015

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

2 Years

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

France: 11

Country: Number of subjects enrolled

Germany: 4

Country: Number of subjects enrolled

United States: 17

Country: Number of subjects enrolled

Italy: 4

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

No text entered

Screening 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.

Period 1 title

Period 1 (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

50 mg LY3039478 + Dexamethasone

Arm 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.

Arm type

Experimental

Investigational medicinal product name

LY3039478

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

50 mg LY3039478 administered orally three times per week (TIW).

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles.

75 mg LY3039478 + Dexamethasone

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

LY3039478

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

75 mg LY3039478 administered orally three times per week (TIW).

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles.

100 mg LY3039478 + Dexamethasone

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

LY3039478

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

100 mg LY3039478 administered orally three times per week (TIW).

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles.

125 mg LY3039478 + Dexamethasone

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

LY3039478

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

125 mg LY3039478 administered orally three times per week (TIW).

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles.

Number of subjects in period 1	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Started	6	12	15	3
Completed	3	7	11	3
Not completed	3	5	4	0
Physician decision	-	1	-	-
Adverse Event	1	-	1	-
Death	1	2	-	-
Progressive Disease	1	2	3	-

Baseline characteristics

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Reporting group title

50 mg LY3039478 + Dexamethasone

Reporting group description

Reporting group title

75 mg LY3039478 + Dexamethasone

Reporting group description

Reporting group title

100 mg LY3039478 + Dexamethasone

Reporting group description

Reporting group title

125 mg LY3039478 + Dexamethasone

Reporting group description

Reporting group values	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone	Total
Number of subjects	6	12	15	3	36
Age categorical
Units: Subjects
In utero					0
Preterm newborn infants (gestational age < 37 wks)					0
Newborns (0-27 days)					0
Infants and toddlers (28 days-23 months)					0
Children (2-11 years)					0
Adolescents (12-17 years)					0
Adults (18-64 years)					0
From 65-84 years					0
85 years and over					0
Age continuous
All participants who received at least one dose of study drug.
Units: years
arithmetic mean (standard deviation)	38.8 ( 12.2 )	36.4 ( 13.4 )	45.8 ( 14.4 )	26.6 ( 10.6 )	-
Gender categorical
Units: Subjects
Female	0	5	5	1	11
Male	6	7	10	2	25
Ethnicity
Units: Subjects
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
Units: Subjects
Asian	0	1	0	0	1
Black or African American	0	1	1	0	2
White	5	10	12	3	30
Unknown or Not Reported	1	0	2	0	3
Region Of Enrollment
Units: Subjects
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

End points

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Reporting group title

50 mg LY3039478 + Dexamethasone

Reporting group description

Reporting group title

75 mg LY3039478 + Dexamethasone

Reporting group description

Reporting group title

100 mg LY3039478 + Dexamethasone

Reporting group description

Reporting group title

125 mg LY3039478 + Dexamethasone

Reporting group description

Subject analysis set title

All Participants

Subject analysis set type

Full analysis

Subject analysis set description

Part A data.

Primary: Number of Participants With Dose Limiting Toxicities (DLTs)

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End point title

Number of Participants With Dose Limiting Toxicities (DLTs) ^[1]

End point 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). Analysis Population Description (APD) : All participants who received at least one dose of study drug in Part A.

End point type

Primary

End point timeframe

Cycle 1 (Up To 28 Days)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No arm comparison analyses were planned or conducted.

End point values	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Number of subjects analysed	6	12	15	3
Units: participants	0	2	2	3

No statistical analyses for this end point

Primary: Recommended Dose of LY3039478 in Combination With Dexamethasone

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End point title

Recommended Dose of LY3039478 in Combination With Dexamethasone ^[2]

End point 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. APD: All participants who received at least one dose of study drug in Part A.

End point type

Primary

End point timeframe

Cycle 1 (28 Days)

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No arm comparison analyses were planned or conducted.

End point values	All Participants
Number of subjects analysed	36
Units: mg
number (not applicable)	75

No statistical analyses for this end point

Primary: Number of Participants Who Achieve Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi): Overall Remission Rate (ORR)

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End point title

Number of Participants Who Achieve Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi): Overall Remission Rate (ORR) ^[3]

End point 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. APD: All participants who received at least one dose of study drug in Part A.

End point type

Primary

End point timeframe

Baseline to Objective Disease Progression (Up To 2 Months)

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No arm comparison analyses were planned or conducted.

End point values	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Number of subjects analysed	6	12	15	3
Units: participants	1	0	0	0

No statistical analyses for this end point

Secondary: Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination With Dexamethasone in Day 1

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End point title

Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination With Dexamethasone in Day 1

End point description

Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination with Dexamethasone in Day 1. APD: All participants who received at least one dose of study drug in Part A and had evaluable PK data.

End point type

Secondary

End point timeframe

Cycle 1 Day 1: Predose, 1-2, 3-4,6-8,24-30 hours

End point values	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Number of subjects analysed	5	12	15	2 ^[4]
Units: nanogram hour per milliliter (ng*h/mL)
geometric mean (geometric coefficient of variation)	3480 ( 26 )	5000 ( 45 )	5870 ( 49 )	6330 ( 9999 )

Notes
[4] - 9999 = NA ( For n=2, range 3180-12600 was reported)

No statistical analyses for this end point

Secondary: Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0- 48]) of LY3039478 in Combination With Dexamethasone in Day 8

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End point title

Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0- 48]) of LY3039478 in Combination With Dexamethasone in Day 8

End point description

Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0- 48]) of LY3039478 in Combination with Dexamethasone in Day 8. APD: All participants who received at least one dose of study drug in Part A and had evaluable PK data.

End point type

Secondary

End point timeframe

Cycle 1 Day 8: Predose, 1-2, 3-4,6-8,24-30 hours

End point values	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Number of subjects analysed	5	8	12	2 ^[5]
Units: ng*h/mL
geometric mean (geometric coefficient of variation)	3050 ( 18 )	4070 ( 92 )	4640 ( 55 )	8240 ( 9999 )

Notes
[5] - 9999=NA (For n=2, range 4410-16100 was reported.)

No statistical analyses for this end point

Secondary: Number of Participants With CR or CRi and Notch-1 or FBXW7 Mutations

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End point title

Number of Participants With CR or CRi and Notch-1 or FBXW7 Mutations

End point 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. APD: All participants who received at least one dose of study drug in Part A.

End point type

Secondary

End point timeframe

Baseline to Objective Disease Progression (Up To 12 Months)

End point values	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Number of subjects analysed	6	12	15	3
Units: Participants	0	0	0	0

No statistical analyses for this end point

Secondary: Phase 2: Number of Participants Who Achieve CR, CRi or Partial Remission (PR): Overall Remission Rate (ORR) Plus PR

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End point title

Phase 2: Number of Participants Who Achieve CR, CRi or Partial Remission (PR): Overall Remission Rate (ORR) Plus PR

End point description

There were no participants enrolled to Part B and Phase 2 of the study. The plan for Phase 2 was to randomize participants into two groups: LY3039478 + Dexamethasone and Placebo + Dexamethasone. Due to system limitation we cannot present data in the two arms for this outcome measure because number started is "0". The database does not allow a started number/enrolled number of "0" therefore reported data in the existing 4 Part A arms.

End point type

Secondary

End point timeframe

Baseline to Objective Disease Progression (Up To 12 Months)

End point values	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Number of subjects analysed	0 ^[6]	0 ^[7]	0 ^[8]	0 ^[9]
Units: participants

Notes
[6] - There were no participants enrolled to Part B and Phase 2 of the study.
[7] - There were no participants enrolled to Part B and Phase 2 of the study.
[8] - There were no participants enrolled to Part B and Phase 2 of the study.
[9] - There were no participants enrolled to Part B and Phase 2 of the study.

No statistical analyses for this end point

Secondary: Phase 2: Number of Participants Who Achieve PR

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End point title

Phase 2: Number of Participants Who Achieve PR

End point description

End point type

Secondary

End point timeframe

Date of CR, CRi, or PR to Date of Relapse or Death from Any Cause (Approximately 1 Year)

End point values	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Number of subjects analysed	0 ^[10]	0 ^[11]	0 ^[12]	0 ^[13]
Units: participants

Notes
[10] - There were no participants enrolled to Part B and Phase 2 of the study.
[11] - There were no participants enrolled to Part B and Phase 2 of the study.
[12] - There were no participants enrolled to Part B and Phase 2 of the study.
[13] - There were no participants enrolled to Part B and Phase 2 of the study.

No statistical analyses for this end point

Secondary: Phase 2: Duration of Remission (DoR)

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End point title

Phase 2: Duration of Remission (DoR)

End point description

End point type

Secondary

End point timeframe

Date of CR, CRi, or PR to Date of Relapse or Death from Any Cause (Approximately 1 Year)

End point values	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Number of subjects analysed	0 ^[14]	0 ^[15]	0 ^[16]	0 ^[17]
Units: years
median (confidence interval 95%)	( to )	( to )	( to )	( to )

Notes
[14] - There were no participants enrolled to Part B and Phase 2 of the study.
[15] - There were no participants enrolled to Part B and Phase 2 of the study.
[16] - There were no participants enrolled to Part B and Phase 2 of the study.
[17] - There were no participants enrolled to Part B and Phase 2 of the study.

No statistical analyses for this end point

Secondary: Phase 2:Relapse Free Survival (RFS)

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End point title

Phase 2:Relapse Free Survival (RFS)

End point description

End point type

Secondary

End point timeframe

Date of CR to Relapse or Death from any Cause (Approximately 1 Year)

End point values	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Number of subjects analysed	0 ^[18]	0 ^[19]	0 ^[20]	0 ^[21]
Units: Years
median (confidence interval 95%)	( to )	( to )	( to )	( to )

Notes
[18] - There were no participants enrolled to Part B and Phase 2 of the study.
[19] - There were no participants enrolled to Part B and Phase 2 of the study.
[20] - There were no participants enrolled to Part B and Phase 2 of the study.
[21] - There were no participants enrolled to Part B and Phase 2 of the study.

No statistical analyses for this end point

Secondary: Phase 2: Event Free Survival (EFS)

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End point title

Phase 2: Event Free Survival (EFS)

End point description

End point type

Secondary

End point timeframe

Baseline to Objective Disease Progression or Death from Any Cause (Approximately 1 Year)

End point values	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Number of subjects analysed	0 ^[22]	0 ^[23]	0 ^[24]	0 ^[25]
Units: Years
median (confidence interval 95%)	( to )	( to )	( to )	( to )

Notes
[22] - There were no participants enrolled to Part B and Phase 2 of the study.
[23] - There were no participants enrolled to Part B and Phase 2 of the study.
[24] - There were no participants enrolled to Part B and Phase 2 of the study.
[25] - There were no participants enrolled to Part B and Phase 2 of the study.

No statistical analyses for this end point

Secondary: Phase 2: Overall Survival (OS)

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End point title

Phase 2: Overall Survival (OS)

End point description

End point type

Secondary

End point timeframe

Baseline to the Date of Death from Any Cause (Approximately 1.5 Years)

End point values	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Number of subjects analysed	0 ^[26]	0 ^[27]	0 ^[28]	0 ^[29]
Units: Years
median (confidence interval 95%)	( to )	( to )	( to )	( to )

Notes
[26] - There were no participants enrolled to Part B and Phase 2 of the study.
[27] - There were no participants enrolled to Part B and Phase 2 of the study.
[28] - There were no participants enrolled to Part B and Phase 2 of the study.
[29] - There were no participants enrolled to Part B and Phase 2 of the study.

No statistical analyses for this end point

Secondary: Phase 2: Change From Baseline in the Functional Assessment of Cancer Therapy-Leukemia-General (FACT-Leu-G) Score

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End point title

Phase 2: Change From Baseline in the Functional Assessment of Cancer Therapy-Leukemia-General (FACT-Leu-G) Score

End point description

End point type

Secondary

End point timeframe

Baseline, End of Study (Approximately 1.5 Years)

End point values	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Number of subjects analysed	0 ^[30]	0 ^[31]	0 ^[32]	0 ^[33]
Units: units on a scale
least squares mean (standard error)	( )	( )	( )	( )

Notes
[30] - There were no participants enrolled to Part B and Phase 2 of the study.
[31] - There were no participants enrolled to Part B and Phase 2 of the study.
[32] - There were no participants enrolled to Part B and Phase 2 of the study.
[33] - There were no participants enrolled to Part B and Phase 2 of the study.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Entire Study

Adverse event reporting additional description

I6F-MC-JJCB

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.1

Reporting group title

50 mg LY3039478 + Dexamethasone

Reporting group description

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.

Reporting group title

75 mg LY3039478 + Dexamethasone

Reporting group description

Reporting group title

100 mg LY3039478 + Dexamethasone

Reporting group description

Reporting group title

125 mg LY3039478 + Dexamethasone

Reporting group description

Serious adverse events	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 6 (100.00%)	11 / 12 (91.67%)	9 / 15 (60.00%)	3 / 3 (100.00%)
number of deaths (all causes)	1	4	1	1
number of deaths resulting from adverse events	0	1	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
nasopharyngeal cancer
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
hypotension
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	3 / 12 (25.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
fatigue
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	2 / 12 (16.67%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
non-cardiac chest pain
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pain
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pyrexia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
aspiration
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
dyspnoea
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypoxia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
respiratory failure
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Investigations
lipase increased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
weight decreased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
overdose
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
generalised tonic-clonic seizure
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
haemorrhage intracranial
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
syncope
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	2 / 12 (16.67%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
febrile neutropenia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
colitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
diarrhoea
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	2 / 12 (16.67%)	2 / 15 (13.33%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	2 / 2	3 / 3	4 / 4	5 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastric ulcer
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastrointestinal haemorrhage
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	2 / 12 (16.67%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ileus
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
intestinal obstruction
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
nausea
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
upper gastrointestinal haemorrhage
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
vomiting
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
acute kidney injury
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
muscular weakness
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
atypical pneumonia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
bacteraemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
device related infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
h1n1 influenza
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
lung infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
neutropenic infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
perirectal abscess
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pneumonia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	2 / 12 (16.67%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
sepsis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
septic shock
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
upper respiratory tract infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
dehydration
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	3 / 12 (25.00%)	2 / 15 (13.33%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	1 / 3	3 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
failure to thrive
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypokalaemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	3 / 3	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
tumour lysis syndrome
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	50 mg LY3039478 + Dexamethasone	75 mg LY3039478 + Dexamethasone	100 mg LY3039478 + Dexamethasone	125 mg LY3039478 + Dexamethasone
Total subjects affected by non serious adverse events
subjects affected / exposed	6 / 6 (100.00%)	12 / 12 (100.00%)	15 / 15 (100.00%)	3 / 3 (100.00%)
Vascular disorders
flushing
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
hypertension
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
hypotension
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	2	1	2	0
peripheral artery thrombosis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
General disorders and administration site conditions
asthenia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	3 / 12 (25.00%)	3 / 15 (20.00%)	0 / 3 (0.00%)
occurrences all number	0	5	3	0
chest pain
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
chills
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
complication associated with device
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
face oedema
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	1	1	0
fatigue
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	3 / 12 (25.00%)	6 / 15 (40.00%)	2 / 3 (66.67%)
occurrences all number	0	3	10	8
malaise
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
mucosal inflammation
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1
multiple organ dysfunction syndrome
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
non-cardiac chest pain
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	2 / 15 (13.33%)	1 / 3 (33.33%)
occurrences all number	0	1	2	1
oedema peripheral
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	2	3	2	0
pyrexia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	2 / 6 (33.33%)	3 / 12 (25.00%)	4 / 15 (26.67%)	1 / 3 (33.33%)
occurrences all number	2	4	4	1
Immune system disorders
hypersensitivity
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	1	1	0
cough
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	3 / 6 (50.00%)	1 / 12 (8.33%)	6 / 15 (40.00%)	0 / 3 (0.00%)
occurrences all number	3	1	6	0
dysphonia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	1	0	0
dyspnoea
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	2 / 12 (16.67%)	3 / 15 (20.00%)	0 / 3 (0.00%)
occurrences all number	1	2	3	0
epistaxis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	3 / 6 (50.00%)	1 / 12 (8.33%)	4 / 15 (26.67%)	1 / 3 (33.33%)
occurrences all number	3	1	4	2
hiccups
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1
hypoxia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
nasal congestion
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0
oropharyngeal pain
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	2 / 6 (33.33%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	2	0	1	0
pleural effusion
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	0	0	3	0
pneumonitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
productive cough
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	2	1	0
pulmonary fibrosis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
pulmonary oedema
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
respiratory failure
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
rhinitis allergic
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0
sinus congestion
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
tachypnoea
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
wheezing
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
Psychiatric disorders
anxiety
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
depressed mood
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1
depression
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	0	1	2	0
dysphoria
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
insomnia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	4 / 15 (26.67%)	0 / 3 (0.00%)
occurrences all number	0	1	5	0
mental disorder
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
Investigations
alanine aminotransferase increased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	2 / 6 (33.33%)	2 / 12 (16.67%)	3 / 15 (20.00%)	1 / 3 (33.33%)
occurrences all number	2	4	5	2
amylase increased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	2	0
aspartate aminotransferase increased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	2 / 12 (16.67%)	4 / 15 (26.67%)	1 / 3 (33.33%)
occurrences all number	1	6	8	3
blood bilirubin increased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	1 / 12 (8.33%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	1	1	4	0
blood creatinine increased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	1	1	1	0
blood glucose increased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
blood lactate dehydrogenase increased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	1	3	0
blood phosphorus increased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
c-reactive protein increased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	1	0	5	0
chest x-ray abnormal
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
gamma-glutamyltransferase increased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	1 / 15 (6.67%)	1 / 3 (33.33%)
occurrences all number	1	0	2	5
immunoglobulins decreased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
lipase increased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	2 / 12 (16.67%)	4 / 15 (26.67%)	0 / 3 (0.00%)
occurrences all number	2	8	8	0
platelet count decreased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	1 / 12 (8.33%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	1	1	9	0
weight decreased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	1 / 12 (8.33%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	2	1	0	1
weight increased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	3	0	0
white blood cell count decreased
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	6	0	0	0
Injury, poisoning and procedural complications
contusion
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
fall
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
muscle strain
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
overdose
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
Cardiac disorders
atrial fibrillation
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
bradycardia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	2	0
cardiac failure congestive
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
pericardial effusion
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
sinus bradycardia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1
sinus tachycardia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	1 / 3 (33.33%)
occurrences all number	0	1	1	1
supraventricular tachycardia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
tachycardia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	2 / 12 (16.67%)	3 / 15 (20.00%)	0 / 3 (0.00%)
occurrences all number	0	2	3	0
ventricular fibrillation
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
ventricular tachycardia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
Nervous system disorders
ageusia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
aphonia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
depressed level of consciousness
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
dizziness
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	1	1	0
dysgeusia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	1	0	2	0
headache
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	0	0	0
lethargy
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	1	1	1	0
metabolic encephalopathy
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
seizure
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
syncope
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	1	0	1
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	3 / 6 (50.00%)	2 / 12 (16.67%)	3 / 15 (20.00%)	1 / 3 (33.33%)
occurrences all number	4	3	4	1
febrile neutropenia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	1 / 15 (6.67%)	1 / 3 (33.33%)
occurrences all number	1	0	1	1
immune thrombocytopenic purpura
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1
increased tendency to bruise
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1
leukocytosis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	0	0	4	0
thrombocytopenia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	1 / 12 (8.33%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	2	1	2	0
Ear and labyrinth disorders
ear pain
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
hypoacusis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	1	0	0
tinnitus
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
Eye disorders
exophthalmos
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
eye pain
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
ocular hyperaemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
periorbital oedema
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
photophobia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
vision blurred
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
vitritis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
Gastrointestinal disorders
abdominal discomfort
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
abdominal distension
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	2 / 6 (33.33%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	2	0	1	0
abdominal pain
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	1 / 12 (8.33%)	3 / 15 (20.00%)	0 / 3 (0.00%)
occurrences all number	1	1	3	0
abdominal pain upper
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	2 / 15 (13.33%)	1 / 3 (33.33%)
occurrences all number	0	0	2	1
colitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
constipation
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	4 / 15 (26.67%)	1 / 3 (33.33%)
occurrences all number	0	1	4	1
diarrhoea
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	3 / 6 (50.00%)	7 / 12 (58.33%)	8 / 15 (53.33%)	2 / 3 (66.67%)
occurrences all number	3	20	19	6
dry mouth
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	3 / 15 (20.00%)	0 / 3 (0.00%)
occurrences all number	0	0	3	0
dyspepsia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	2 / 12 (16.67%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	0	2	2	0
dysphagia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	2 / 6 (33.33%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	2	1	1	0
eructation
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
flatulence
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
gastric haemorrhage
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
gastrointestinal haemorrhage
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
gastrooesophageal reflux disease
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	1 / 15 (6.67%)	1 / 3 (33.33%)
occurrences all number	1	0	1	1
gingival bleeding
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	1	1	0
haematemesis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
haematochezia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1
haemorrhoids
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
ileus
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	1 / 3 (33.33%)
occurrences all number	0	1	1	1
lip dry
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
mouth haemorrhage
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
nausea
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	5 / 12 (41.67%)	5 / 15 (33.33%)	3 / 3 (100.00%)
occurrences all number	1	8	6	8
oesophagitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
pancreatitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
proctalgia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
proctitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	0	0	2	0
rectal haemorrhage
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
stomatitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	3 / 15 (20.00%)	0 / 3 (0.00%)
occurrences all number	1	0	3	0
toothache
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
vomiting
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	2 / 6 (33.33%)	3 / 12 (25.00%)	8 / 15 (53.33%)	3 / 3 (100.00%)
occurrences all number	2	4	8	9
Hepatobiliary disorders
hepatomegaly
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
Skin and subcutaneous tissue disorders
alopecia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
dermatitis acneiform
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
dermatitis allergic
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
dry skin
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
ecchymosis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
erythema
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
hand dermatitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
night sweats
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
pruritus
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
rash
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	2 / 12 (16.67%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	0	0
rash maculo-papular
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	2 / 12 (16.67%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	1	2	3	0
scab
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
skin ulcer
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
Renal and urinary disorders
acute kidney injury
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	2 / 6 (33.33%)	2 / 12 (16.67%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	2	2	1	0
dysuria
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
urinary retention
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1
Endocrine disorders
adrenal insufficiency
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
diabetes insipidus
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	0	2	2	0
back pain
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
bone pain
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
muscle spasms
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
muscular weakness
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	1	1	1	0
musculoskeletal pain
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
myalgia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	1	1	0
pain in extremity
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0
Infections and infestations
bacteraemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
bronchitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	2 / 12 (16.67%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	2	1	0
bronchopulmonary aspergillosis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
candida infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
cellulitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1
clostridium difficile colitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
clostridium difficile infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	2 / 12 (16.67%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	3	1	0
conjunctivitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	0	0	0
corona virus infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
cytomegalovirus infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
dermatophytosis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
enterococcal infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
epstein-barr virus infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1
folliculitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1
gastroenteritis norovirus
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
hordeolum
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
infective glossitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1
influenza
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
lung infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	2	0	2	0
mucosal infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
nasopharyngitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
oral candidiasis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
pharyngitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
pneumonia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	1	1	0
pneumonia cytomegaloviral
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
pneumonia fungal
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
pseudomonas infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	0	0
rhinitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
rhinovirus infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	1	0	1
sepsis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
septic encephalopathy
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
sinusitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
staphylococcal infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	0	1
tonsillitis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
upper respiratory tract infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
urinary tract infection
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
Metabolism and nutrition disorders
decreased appetite
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	2 / 12 (16.67%)	5 / 15 (33.33%)	0 / 3 (0.00%)
occurrences all number	1	3	5	0
dehydration
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	1	1	1	0
fluid overload
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0
hyperglycaemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	2 / 6 (33.33%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	4	0	0	0
hyperkalaemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	0	1	3	0
hypernatraemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	4	0
hyperphosphataemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
hyperuricaemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	2 / 12 (16.67%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	0	0
hypoalbuminaemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	1 / 3 (33.33%)
occurrences all number	0	0	1	1
hypocalcaemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	5 / 15 (33.33%)	0 / 3 (0.00%)
occurrences all number	0	2	7	0
hypokalaemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	2 / 6 (33.33%)	3 / 12 (25.00%)	8 / 15 (53.33%)	0 / 3 (0.00%)
occurrences all number	2	5	14	0
hypomagnesaemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	2 / 6 (33.33%)	2 / 12 (16.67%)	2 / 15 (13.33%)	0 / 3 (0.00%)
occurrences all number	2	8	3	0
hyponatraemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	1	1	1	0
hypophosphataemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	4 / 15 (26.67%)	1 / 3 (33.33%)
occurrences all number	1	0	4	5
hypoproteinaemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0
hypouricaemia
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
lactic acidosis
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0
malnutrition
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 3 (0.00%)
occurrences all number	0	1	1	0
tumour lysis syndrome
alternative dictionary used: MedDRA 20.1
subjects affected / exposed	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

04 Jun 2015

This study was amended at the request of the Food and Drug Administration (FDA) to clarify the criteria for DLTs and to change the PK sampling. In addition, CSF sampling was simplified based on new data; the CSF sampling has been reduced to one draw. PK sampling for Dexamethasone during the phase 1 portion of the study was added and one additional time point for the determination of plasma concentrations of LY3039478 and dexamethasone was added during Phase 2 portion of the study.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

There were no participants enrolled to Part B and Phase 2 of the study.

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Clinical trials

Clinical Trial Results: A Phase 1b/Randomized Phase 2 Study to Evaluate LY3039478 in Combination with Dexamethasone in T-ALL/T-LBL Patients

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Participants With Dose Limiting Toxicities (DLTs)

Primary: Number of Participants With Dose Limiting Toxicities (DLTs)

Primary: Recommended Dose of LY3039478 in Combination With Dexamethasone

Primary: Recommended Dose of LY3039478 in Combination With Dexamethasone

Primary: Number of Participants Who Achieve Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi): Overall Remission Rate (ORR)

Primary: Number of Participants Who Achieve Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi): Overall Remission Rate (ORR)

Secondary: Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination With Dexamethasone in Day 1

Secondary: Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination With Dexamethasone in Day 1

Secondary: Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0- 48]) of LY3039478 in Combination With Dexamethasone in Day 8

Secondary: Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0- 48]) of LY3039478 in Combination With Dexamethasone in Day 8

Secondary: Number of Participants With CR or CRi and Notch-1 or FBXW7 Mutations

Secondary: Number of Participants With CR or CRi and Notch-1 or FBXW7 Mutations

Secondary: Phase 2: Number of Participants Who Achieve CR, CRi or Partial Remission (PR): Overall Remission Rate (ORR) Plus PR

Secondary: Phase 2: Number of Participants Who Achieve CR, CRi or Partial Remission (PR): Overall Remission Rate (ORR) Plus PR

Secondary: Phase 2: Number of Participants Who Achieve PR

Secondary: Phase 2: Number of Participants Who Achieve PR

Secondary: Phase 2: Duration of Remission (DoR)

Secondary: Phase 2: Duration of Remission (DoR)

Secondary: Phase 2:Relapse Free Survival (RFS)

Secondary: Phase 2:Relapse Free Survival (RFS)

Secondary: Phase 2: Event Free Survival (EFS)

Secondary: Phase 2: Event Free Survival (EFS)

Secondary: Phase 2: Overall Survival (OS)

Secondary: Phase 2: Overall Survival (OS)

Secondary: Phase 2: Change From Baseline in the Functional Assessment of Cancer Therapy-Leukemia-General (FACT-Leu-G) Score

Secondary: Phase 2: Change From Baseline in the Functional Assessment of Cancer Therapy-Leukemia-General (FACT-Leu-G) Score

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 1b/Randomized Phase 2 Study to Evaluate LY3039478 in Combination with Dexamethasone in T-ALL/T-LBL Patients