A Multicenter, Open-label, Phase 1b Study of Carfilzomib,... | NCT01980589

Label	Type	Description	Intervention Names
Carfilzomib, Cyclophosphamide and Dexamethasone (CCd)	Experimental	Participants received carfilzomib, cyclophosphamide and dexamethasone for up to eight 28-day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.	Drug: Carfilzomib Drug: Cyclophosphamide Drug: Dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
Carfilzomib	Drug	Carfilzomib administered as a 30-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. On Days 1 and 2 of Cycle 1, all participants received carfilzomib at 20 mg/m².

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Dose-limiting Toxicities (DLTs)	The MTD is defined as the highest carfilzomib dose at which fewer than 33% of participants experience a treatment-related dose-limiting toxicity (DLT) during the first 28-day cycle. The number of participants who experienced a DLT is reported. Dose-limiting toxicities are defined as any of the following carfilzomib-related adverse events: Nonhematologic: ≥ Grade 3 non-hematological toxicity ≥ Grade 3 acute kidney injury (creatinine > 3 × baseline or > 4.0 mg/dL) lasting > 72 hours Hematologic: Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10^9/L) lasting for > 7 days Febrile neutropenia (ANC < 1.0 × 10^9/L with a fever ≥ 38.3ºC) of any duration Grade 4 thrombocytopenia (< 25 × 10^9/L) that persists for > 14 days, despite holding treatment Grade 3 or 4 thrombocytopenia associated with > Grade 1 bleeding	First cycle treatment over 28-days

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR)	Participants were evaluated for disease response and progression by the investigator according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). Disease response and progression assessments included serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum immunofixation, serum free light chain (SFLC), bone marrow sample (including fluorescent in situ hybridization [FISH]), plasmacytoma evaluation, and skeletal survey. Overall response rate is defined as the percentage of participants with a best response of stringent complete response, complete response, very good partial response (VGPR), or partial response.

Eligibility Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
California Cancer Associates for Research and Excellence		Encinitas	California		United States
James R. Berenson, MD

ID	Title	Description
FG000	Carfilzomib 36 mg/m²	Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.

ID	Title	Description
BG000	Carfilzomib 36 mg/m²	Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
BG001	Carfilzomib 45 mg/m²	Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
BG002	Carfilzomib 56 mg/m²	Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0003 BG0013 BG00216 BG00322

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)

The MTD is defined as the highest carfilzomib dose at which fewer than 33% of participants experience a treatment-related dose-limiting toxicity (DLT) during the first 28-day cycle. The number of participants who experienced a DLT is reported.

Dose-limiting toxicities are defined as any of the following carfilzomib-related adverse events:

Nonhematologic:

≥ Grade 3 non-hematological toxicity
≥ Grade 3 acute kidney injury (creatinine > 3 × baseline or > 4.0 mg/dL) lasting > 72 hours

Hematologic:

Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10^9/L) lasting for > 7 days
Febrile neutropenia (ANC < 1.0 × 10^9/L with a fever ≥ 38.3ºC) of any duration
Grade 4 thrombocytopenia (< 25 × 10^9/L) that persists for > 14 days, despite holding treatment
Grade 3 or 4 thrombocytopenia associated with > Grade 1 bleeding

The Safety population is defined as all enrolled participants who received any study treatment.

Posted

Number

participants

First cycle treatment over 28-days

ID	Title	Description
OG000	Carfilzomib 36 mg/m²	Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
OG001	Carfilzomib 45 mg/m²	Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
OG002	Carfilzomib 56 mg/m²	Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.

Units	Counts
Participants	OG0003 OG0013 OG00216

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020

Secondary

Overall Response Rate (ORR)

Participants were evaluated for disease response and progression by the investigator according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). Disease response and progression assessments included serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum immunofixation, serum free light chain (SFLC), bone marrow sample (including fluorescent in situ hybridization [FISH]), plasmacytoma evaluation, and skeletal survey. Overall response rate is defined as the percentage of participants with a best response of stringent complete response, complete response, very good partial response (VGPR), or partial response.

Safety population

Posted

Number

95% Confidence Interval

percentage of participants

Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.

ID	Title	Description
OG000	Carfilzomib 36 mg/m²	Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
OG001	Carfilzomib 45 mg/m²	Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.

Secondary

Time To Response (TTR)

Time to response is defined as months from treatment start to first documentation of response of partial response or better. Summary of time to response includes confirmed responders of PR or better only.

Participants with an overall response

Posted

Median

Full Range

months

Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.

ID	Title	Description
OG000	Carfilzomib 36 mg/m²	Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
OG001	Carfilzomib 45 mg/m²	Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.

Secondary

Number of Participants With Adverse Events

Adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 and using the following scale:

Grade 1 = Mild, Grade 3 = Moderate; Grade 3 = Severe, Grade 4 = Life-threatening; Grade 5 = Fatal.

Safety population

Posted

Number

participants

From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.

ID	Title	Description
OG000	Carfilzomib 36 mg/m²	Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
OG001	Carfilzomib 45 mg/m²	Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Carfilzomib 36 mg/m²	Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.	0	3	3	3
EG001	Carfilzomib 45 mg/m²	Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.	1	3	3	3
EG002	Carfilzomib 56 mg/m²	Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.	5	16	16	16

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0028 affected16 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected16 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0026 affected16 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0024 affected16 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Angina unstable	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Palpitations	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected3 at risk EG0010 affected3 at risk EG0022 affected16 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Diplopia	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Vision blurred	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected16 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0023 affected16 at risk
Dental caries	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0029 affected16 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Eructation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Flatulence	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected16 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected3 at risk EG0013 affected3 at risk EG00211 affected16 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0012 affected3 at risk EG0026 affected16 at risk
Application site rash	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Asthenia	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected16 at risk
Breakthrough pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Catheter site erythema	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Catheter site pruritus	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Chest discomfort	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Chills	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0023 affected16 at risk
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0028 affected16 at risk
Feeling abnormal	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Infusion site pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Localised oedema	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Malaise	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Mass	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Nodule	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Oedema	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Oedema peripheral	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0025 affected16 at risk
Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0023 affected16 at risk
Peripheral swelling	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0025 affected16 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Bronchitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Candida infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Influenza	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected16 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Onychomycosis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Rhinitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Septic shock	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Sinusitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0026 affected16 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected16 at risk
Vaginal infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Alanine aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Blood creatinine increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0025 affected16 at risk
Blood iron decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Blood potassium decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Blood urea increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Body temperature increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Ejection fraction decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Hepatic enzyme increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Neutrophil count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Neutrophil count increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Platelet count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Transaminases increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Urine output increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Weight increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
White blood cell count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected16 at risk
White blood cell count increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0024 affected16 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected16 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected16 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected16 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected16 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected16 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected3 at risk EG0010 affected3 at risk EG0025 affected16 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected3 at risk EG0011 affected3 at risk EG0024 affected16 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Lower extremity mass	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0023 affected16 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected16 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected3 at risk EG0020 affected16 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0023 affected16 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected3 at risk EG0010 affected3 at risk EG0025 affected16 at risk
Ageusia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Disturbance in attention	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Dizziness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Dysarthria	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Dysgeusia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0021 affected16 at risk
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected3 at risk EG0027 affected16 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Tremor	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Anxiety	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Depression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Insomnia	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected3 at risk EG0012 affected3 at risk EG0026 affected16 at risk
Restlessness	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected16 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected16 at risk
Incontinence	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Nocturia	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Testicular mass	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected3 at risk EG0010 affected3 at risk EG00210 affected16 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected3 at risk EG0011 affected3 at risk EG0022 affected16 at risk
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected3 at risk EG0012 affected3 at risk EG0024 affected16 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Hypocapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0024 affected16 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected16 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Interstitial granulomatous dermatitis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Macule	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected16 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected16 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0022 affected16 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Hot flush	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected16 at risk
Hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Peripheral venous disease	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Phlebitis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D000074583	Short Chain Dehydrogenase-Reductases
D064430	NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases
D000429	Alcohol Oxidoreductases
D010088	Oxidoreductases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D025521	Tumor Suppressor Proteins
D009363	Neoplasm Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery occlusion	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected16 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected16 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected16 at risk

ID	Term
C524865	carfilzomib
D000074584	WW Domain-Containing Oxidoreductase
D003520	Cyclophosphamide
D003907	Dexamethasone