A Study of LY3039478 in Combination With Dexamethasone in... | NCT02518113

ID	Type	Description	Link
I6F-MC-JJCB	Other Identifier	Eli Lilly and Company
2014-005024-10	EudraCT Number

Label	Type	Description	Intervention Names
LY3039478 + Dexamethasone (Adult)	Experimental	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.	Drug: LY3039478 Drug: Dexamethasone
LY3039478 + Dexamethasone (Pediatric)	Experimental	Part B: LY3039478 administered orally TIW at escalating doses and dexamethasone administered orally twice a day (BID) on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression. There were no participants enrolled to Part B of the study.	Drug: LY3039478 Drug: Dexamethasone
Phase 2: LY3039478 + Dexamethasone	Experimental	LY3039478 administered orally TIW and dexamethasone administered orally BID on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression. There were no participants enrolled to Phase 2 of the study.

Name	Type	Description	Arm Group Labels	Other Names
LY3039478	Drug	Administered orally	LY3039478 + Dexamethasone (Adult) LY3039478 + Dexamethasone (Pediatric) Phase 2: LY3039478 + Dexamethasone

Measure	Description	Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)	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).	Cycle 1 (Up To 28 Days)
Recommended Dose of LY3039478 in Combination With Dexamethasone	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.	Cycle 1 (28 Days)
Number of Participants Who Achieve Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi): Overall Remission Rate (ORR)	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.	Baseline to Objective Disease Progression (Up To 2 Months)

Measure	Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination With Dexamethasone in Day 1	Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination with Dexamethasone in Day 1	Cycle 1 Day 1: Predose, 1-2, 3-4,6-8,24-30 hours

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope National Medical Center		Duarte	California	91010-0269	United States
Dana Farber Cancer Institute

PubMed Identifier	Type	Citation	Retractions
33107983	Derived	Borthakur G, Martinelli G, Raffoux E, Chevallier P, Chromik J, Lithio A, Smith CL, Yuen E, Oakley GJ 3rd, Benhadji KA, DeAngelo DJ. Phase 1 study to evaluate Crenigacestat (LY3039478) in combination with dexamethasone in patients with T-cell acute lymphoblastic leukemia and lymphoma. Cancer. 2021 Feb 1;127(3):372-380. doi: 10.1002/cncr.33188. Epub 2020 Oct 27.

Label	URL
Click here for more information about this study: A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL	View source

ID	Title	Description
FG000	50 mg LY3039478 + Dexamethasone	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.
FG001	75 mg LY3039478 + Dexamethasone

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 4, 2015	Jan 11, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Dose Limiting Toxicities (DLTs)

All participants who received at least one dose of study drug in Part A.

Posted

Count of Participants

Participants

Cycle 1 (Up To 28 Days)

ID	Title	Description
OG000	50 mg LY3039478 + Dexamethasone	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.
OG001	75 mg LY3039478 + Dexamethasone	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.
OG002	100 mg LY3039478 + Dexamethasone	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.
OG003	125 mg LY3039478 + Dexamethasone	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.

Units	Counts
Participants	OG0006 OG00112 OG00215 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0012 OG0022 OG003

Primary

Recommended Dose of LY3039478 in Combination With Dexamethasone

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.

All participants who received at least one dose of study drug in Part A.

Posted

Number

Cycle 1 (28 Days)

ID	Title	Description
OG000	All Participants	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.

Primary

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

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.

All participants who received at least one dose of study drug in Part A.

Posted

Count of Participants

Participants

Baseline to Objective Disease Progression (Up To 2 Months)

ID	Title	Description
OG000	50 mg LY3039478 + Dexamethasone	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.
OG001	75 mg LY3039478 + Dexamethasone	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.
OG002

Secondary

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

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

All participants who received at least one dose of study drug in Part A and had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram hour per milliliter (ng*h/mL)

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

ID	Title	Description
OG000	50 mg LY3039478 + Dexamethasone	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.
OG001	75 mg LY3039478 + Dexamethasone	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.
OG002	100 mg LY3039478 + Dexamethasone	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.

Secondary

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

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

All participants who received at least one dose of study drug in Part A and had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*h/mL

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

ID	Title	Description
OG000	50 mg LY3039478 + Dexamethasone	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.
OG001	75 mg LY3039478 + Dexamethasone	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.
OG002	100 mg LY3039478 + Dexamethasone	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.

Secondary

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

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.

All participants who received at least one dose of study drug in Part A.

Posted

Count of Participants

Participants

Baseline to Objective Disease Progression (Up To 12 Months)

ID	Title	Description
OG000	50 mg LY3039478 + Dexamethasone	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.
OG001	75 mg LY3039478 + Dexamethasone	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.
OG002	100 mg LY3039478 + Dexamethasone

Secondary

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

Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.

Posted

Baseline to Objective Disease Progression (Up To 12 Months)

ID	Title	Description
OG000	LY3039478 + Dexamethasone	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.
OG001	Placebo + Dexamethasone	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.

Units	Counts
Participants	OG000

Secondary

Phase 2: Number of Participants Who Achieve PR

Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.

Posted

Baseline to Objective Disease Progression (Up To 12 Months)

ID	Title	Description
OG000	LY3039478 + Dexamethasone	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.
OG001	Placebo + Dexamethasone	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.

Units	Counts
Participants	OG000

Secondary

Phase 2: Duration of Remission (DoR)

Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.

Posted

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

ID	Title	Description
OG000	LY3039478 + Dexamethasone	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.
OG001	Placebo + Dexamethasone	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.

Units	Counts
Participants	OG000

Secondary

Phase 2:Relapse Free Survival (RFS)

Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.

Posted

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

ID	Title	Description
OG000	LY3039478 + Dexamethasone	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.
OG001	Placebo + Dexamethasone	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.

Units	Counts
Participants	OG000

Secondary

Phase 2: Event Free Survival (EFS)

Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.

Posted

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

ID	Title	Description
OG000	LY3039478 + Dexamethasone	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.
OG001	Placebo + Dexamethasone	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.

Units	Counts
Participants	OG000

Secondary

Phase 2: Overall Survival (OS)

Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.

Posted

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

ID	Title	Description
OG000	LY3039478 + Dexamethasone	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.
OG001	Placebo + Dexamethasone	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.

Units	Counts
Participants	OG000

Secondary

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

Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.

Posted

Baseline, End of Study (Approximately 1.5 Years)

ID	Title	Description
OG000	LY3039478 + Dexamethasone	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.
OG001	Placebo + Dexamethasone	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.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected12 at risk EG0020 events0 affected15 at risk EG0030 events0 affected3 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0012 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0013 events2 affected12 at risk EG0024 events2 affected15 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events2 affected12 at risk EG0020 events0 affected15 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0022 events1 affected15 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected12 at risk EG0020 events0 affected15 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Device related infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
H1n1 influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Lung infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Neutropenic infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0012 events2 affected12 at risk EG0022 events2 affected15 at risk EG003
Sepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Septic shock	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Lipase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Weight decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events3 affected12 at risk EG0023 events2 affected15 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Syncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Hypotension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0013 events3 affected12 at risk EG0020 events0 affected15 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0004 events3 affected6 at risk EG0013 events2 affected12 at risk EG0024 events3 affected15 at risk EG0031 events1 affected3 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0024 events2 affected15 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0011 events1 affected12 at risk EG0022 events2 affected15 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0022 events1 affected15 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected12 at risk EG0023 events3 affected15 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Diabetes insipidus	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Exophthalmos	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Eye pain	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Periorbital oedema	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Photophobia	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Vision blurred	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Vitritis	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected12 at risk EG0023 events3 affected15 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0022 events2 affected15 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0024 events4 affected15 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected6 at risk EG00120 events7 affected12 at risk EG00219 events8 affected15 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0023 events3 affected15 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected12 at risk EG0022 events2 affected15 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Lip dry	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0018 events5 affected12 at risk EG0026 events5 affected15 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0022 events2 affected15 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0023 events3 affected15 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0014 events3 affected12 at risk EG0028 events8 affected15 at risk EG003
Asthenia	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0015 events3 affected12 at risk EG0023 events3 affected15 at risk EG003
Chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Chills	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Complication associated with device	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Face oedema	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events3 affected12 at risk EG00210 events6 affected15 at risk EG003
Malaise	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Mucosal inflammation	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0022 events2 affected15 at risk EG003
Oedema peripheral	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0013 events1 affected12 at risk EG0022 events2 affected15 at risk EG003
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0014 events3 affected12 at risk EG0024 events4 affected15 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected12 at risk EG0021 events1 affected15 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Candida infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events2 affected12 at risk EG0021 events1 affected15 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Corona virus infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Dermatophytosis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Enterococcal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Epstein-barr virus infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Folliculitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Gastroenteritis norovirus	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Hordeolum	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Infective glossitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Lung infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0010 events0 affected12 at risk EG0022 events2 affected15 at risk EG003
Mucosal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Pneumonia fungal	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Pseudomonas infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Rhinitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Sepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Septic encephalopathy	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0014 events2 affected12 at risk EG0025 events3 affected15 at risk EG003
Amylase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0022 events1 affected15 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0016 events2 affected12 at risk EG0028 events4 affected15 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected12 at risk EG0024 events2 affected15 at risk EG003
Blood creatinine increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Blood glucose increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0023 events1 affected15 at risk EG003
Blood phosphorus increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
C-reactive protein increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0025 events1 affected15 at risk EG003
Chest x-ray abnormal	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0022 events1 affected15 at risk EG003
Immunoglobulins decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Lipase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0018 events2 affected12 at risk EG0028 events4 affected15 at risk EG003
Platelet count decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected12 at risk EG0029 events2 affected15 at risk EG003
Weight decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Weight increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
White blood cell count decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0006 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0013 events2 affected12 at risk EG0025 events5 affected15 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0004 events2 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0023 events2 affected15 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0024 events1 affected15 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected12 at risk EG0020 events0 affected15 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected12 at risk EG0027 events5 affected15 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0015 events3 affected12 at risk EG00214 events8 affected15 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0018 events2 affected12 at risk EG0023 events2 affected15 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0024 events4 affected15 at risk EG003
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Hypouricaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected12 at risk EG0022 events2 affected15 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Ageusia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Aphonia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Dizziness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0022 events2 affected15 at risk EG003
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Lethargy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Seizure	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Syncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Depression	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0022 events2 affected15 at risk EG003
Dysphoria	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0025 events4 affected15 at risk EG003
Mental disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0012 events2 affected12 at risk EG0021 events1 affected15 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected6 at risk EG0011 events1 affected12 at risk EG0026 events6 affected15 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0012 events2 affected12 at risk EG0023 events3 affected15 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected6 at risk EG0011 events1 affected12 at risk EG0024 events4 affected15 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0023 events2 affected15 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected12 at risk EG0021 events1 affected15 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Hand dermatitis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected12 at risk EG0020 events0 affected15 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0012 events2 affected12 at risk EG0023 events1 affected15 at risk EG003
Scab	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Flushing	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected12 at risk EG0021 events1 affected15 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected12 at risk EG0020 events0 affected15 at risk EG003
Hypotension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0011 events1 affected12 at risk EG0022 events2 affected15 at risk EG003
Peripheral artery thrombosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected12 at risk EG0020 events0 affected15 at risk EG003

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

ID	Title	Description
BG000	50 mg LY3039478 + Dexamethasone	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.
BG001	75 mg LY3039478 + Dexamethasone	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.
BG002	100 mg LY3039478 + Dexamethasone	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.
BG003	125 mg LY3039478 + Dexamethasone	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.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	50 mg LY3039478 + Dexamethasone	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.	6	6	6	6	6	6
EG001	75 mg LY3039478 + Dexamethasone	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.	8	12	11	12	12	12
EG002	100 mg LY3039478 + Dexamethasone	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	12	15	9	15	15	15
EG003	125 mg LY3039478 + Dexamethasone	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	2	3	3	3	3	3