Open-Label, Dose-Finding Study Evaluating Safety and PK o... | NCT02318329

Label	Type	Description	Intervention Names
Part 1A: FPA144 Dose Escalation Solid Tumors	Experimental	Dose escalation of FPA144 (0.3 mg/kg to 15 mg/kg)	Drug: FPA144
Part 1B: FPA144 Dose Escalation Gastric Cancer	Experimental	Dose escalation of FPA144 (3-10 mg/kg) in patients with gastric cancer	Drug: FPA144
Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors	Experimental	Evaluation of objective responses in patients with tumors with various levels of FGFR2b overexpression	Drug: FPA144

Name	Type	Description	Arm Group Labels	Other Names
FPA144	Drug	FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.	Part 1A: FPA144 Dose Escalation Solid Tumors Part 1B: FPA144 Dose Escalation Gastric Cancer

Measure	Description	Time Frame
Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).	Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)	4 weeks on average
Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only)	Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)	16 weeks on average

Measure	Description	Time Frame
Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration	Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2. • Summary of area under serum concentration-time curve, maximum serum concentration,	16 weeks on average

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Life expectancy of at least 3 months
ECOG performance status of 0 to 1

• In sexually-active patients, willingness to use 2 effective methods of contraception
Adequate hematological and organ function, confirmed by lab values
Tumor tissue must be available for prospective determination of FGFR2b overexpression
- Locally recurrent or metastatic disease that has progressed on or following standard treatment, or is not a candidate for standard treatment
- Histologically or cytologically confirmed transitional cell carcinoma of the genitourinary tract
- Measurable disease as defined by RECIST version 1.1

Exclusion Criteria:

Untreated or symptomatic central nervous system (CNS) metastases
Impaired cardiac function or clinically significant cardiac disease

- Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs </=14 days (</=28 days for patients in Korea) prior to first dose of FPA144
Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI CTCAE Grade 1
Retinal disease or a history of retinal disease or detachment
Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea
Major surgical procedures are not allowed ≤28 days prior to FPA144 administration
Females who are pregnant or breastfeeding; women of childbearing potential must not be considering getting pregnant during the study

- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
Known allergy or hypersensitivity to components of the FPA144 formulation including polysorbate
History of prior malignancy except:
a) Curatively treated non-melanoma skin cancer or
b) Solid tumor treated curatively more than 5 years previously without evidence of recurrence or
c) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect
Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway

Name	Affiliation	Role
Medical Lead	Five Prime Therapeutics, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope Comprehensive Cancer Center		Duarte	California	91010	United States
Ronald Reagan UCLA Medical Center

PubMed Identifier	Type	Citation	Retractions
31094225	Background	Catenacci DV, Tesfaye A, Tejani M, Cheung E, Eisenberg P, Scott AJ, Eng C, Hnatyszyn J, Marina N, Powers J, Wainberg Z. Bemarituzumab with modified FOLFOX6 for advanced FGFR2-positive gastroesophageal cancer: FIGHT Phase III study design. Future Oncol. 2019 Jun;15(18):2073-2082. doi: 10.2217/fon-2019-0141. Epub 2019 May 16.
32167861

ID	Title	Description
FG000	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg	3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
FG001	Part 1A: FPA144 Dose Escalation Solid Tumors 1mg/kg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 30, 2017

Arm/Group Information

ID	Title	Description
BG000	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg	3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
BG001	Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg	3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
BG002	Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg	3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles..
BG003	Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg	3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
BG004	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg	3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
BG005	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg	3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
BG006	Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg	3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.
BG007	Part 1B: FPA144 Dose Escalation Gastric 6 mg/kg	3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.
BG008	Part 1B: FPA144 Dose Escalation Gastric 10 mg/kg	3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 15 mg/kg IV every 2 weeks in 28 day cycles.
BG009	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors	Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
BG010	Total	Total of all reporting groups

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 Protocol Specified Dose-limiting Toxicities (Part 1 Only).

Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)

All patients who received FPA144

Posted

Count of Participants

Participants

4 weeks on average

ID	Title	Description
OG000	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg	3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG001	Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg	3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG002	Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg	3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG003	Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg	3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG004	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg	3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG005	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg	3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG006	Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg	3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.
OG007	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg	3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles.
OG008	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg	3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.

Units	Counts
Participants	OG0003 OG0014 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Primary

Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only)

Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)

All patients who received FPA144

Posted

Count of Participants

Participants

16 weeks on average

ID	Title	Description
OG000	Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg	3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles..
OG001	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg	3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles.
OG002	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg	3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.

Secondary

Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration

Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.

• Summary of area under serum concentration-time curve, maximum serum concentration,

All patients in the PK Full Analysis Population who have sufficient PK samples for the calculation of at least one PK parameter on at least one Study Day. Dose normalized PK parameters were reported so that patients at 0.3 mg/kg were excluded from mean value for part 1a because it is in the non-linear dose range.

Posted

Mean

Standard Deviation

ug/ml

16 weeks on average

ID	Title	Description
OG000	Phase 1a Dose Escalation 0.3 mg/kg	3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG001	Phase 1a Dose Escalation 1 mg/kg	3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG002	Phase 1a Dose Escalation 3 mg/kg	3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG003

Secondary

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Patients with various levels of FGFR2b overexpression in tumor samples treated with bemarituzumab who had baseline and post baseline scans performed.

Posted

Count of Participants

Participants

16 weeks on average

ID	Title	Description
OG000	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg	3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG001	Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg	3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG002	Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg	3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG003

Secondary

Duration of Response Per RECIST 1.1 (Part 2 Only)

Duration of complete or partial response with 95% confidence intervals in gastric cancer population.

Gastric cancer patients with various levels of FGFR2b overexpression treated with FPA144 who had an objective response.

Posted

Median

95% Confidence Interval

Weeks

16 weeks on average

ID	Title	Description
OG000	Part 1/2: FPA144 Dose Expansion Gastric or Other Solid Tumors	Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.

Units	Counts
Participants	OG000

Secondary

Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve

Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.

• Summary of area under serum concentration-time curve, maximum serum concentration,

Posted

Mean

Standard Deviation

ug*day/ml

16 weeks on average

ID	Title	Description
OG000	Phase 1a Dose Escalation 0.3 mg/kg	3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG001	Phase 1a Dose Escalation 1 mg/kg	3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG002	Phase 1a Dose Escalation 3 mg/kg	3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.
OG003

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg	3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	0	3	1	3	3	3
EG001	Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg	3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	0	4	0	4	4	4
EG002	Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg	3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	0	3	2	3	3	3
EG003	Part 1A: FPA144 Dose Escalation Solid Tumors 6.0 mg/kg	3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	0	3	0	3	3	3
EG004	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg	3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	0	3	0	3	2	3
EG005	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg	3 + 3 dose escalation cohort with 15mg/kg FPA144 IV every 2 weeks in 28 day cycles.	0	3	1	3	3	3
EG006	Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg	3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles	0	1	0	1	1	1
EG007	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg	3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles	0	1	0	1	1	1
EG008	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg	3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles	0	6	2	6	6	6
EG009	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors	Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.	5	52	17	52	48	52

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastrointestinal Hemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG0030 affected3 at risk EG0040 affected3 at risk EG0050 affected3 at risk EG0060 affected1 at risk EG0070 affected1 at risk EG0080 affected6 at risk EG0090 affected52 at risk
Liver Abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Abdominal Pain, Upper	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Limbal stem cell deficiency	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Hemorrhoids	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Duodenal Perforation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Septic Shock	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Psoas Abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Acute Kidney Injury	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Azotemia	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
urinary tract obstruction	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Ulcerative Keratitis	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Tumor Hemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Corneal Dystrophy	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Infusion Reaction	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Large intestinal Obstruction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Device Malfunction	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Hematemesis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Intestinal Obstruction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Intestinal Perforation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Peripheral Oedema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Bacteremia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Device Related Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Escherichia Bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG0031 affected3 at risk EG0040 affected3 at risk EG0050 affected3 at risk EG0060 affected1 at risk EG0070 affected1 at risk EG0081 affected6 at risk EG00914 affected52 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Ear Pain	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Eustachian Tube Obstruction	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Dry Eye	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected3 at risk EG0011 affected4 at risk EG0022 affected3 at risk EG003
Eye Disorder	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Eye Pruritus	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Keratitis	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Lacrimation Increased	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Limbal Stem Cell Deficiency	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Metamorphosia	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Abdominal Discomfort	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Abdominal Distention	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Dry Mouth	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Gastrointestinal Sounds Abnormal	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Oesophageal Hemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Asthenia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Chest Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Chills	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Early Satiety	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Facial Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0022 affected3 at risk EG003
Oedema Peripheral	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Anorectal Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Bronchitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Ear Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Fungal Skin Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Oral Herpes	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Sinusitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Skin Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Upper Respiratory Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Infusion Related Reaction	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Muscle Strain	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Alanine Aminotransferase Increase	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Blood Alkaline Phosphatase Increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Blood Creatinine Increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Lymphocyte Count Decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Neutrophil Count Decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Platelet Count Decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Weight Decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0012 affected4 at risk EG0020 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Hypercalcemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Hyperkalemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0021 affected3 at risk EG003
Hypoalbuminemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0021 affected3 at risk EG003
Hypomagnesemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0021 affected3 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Cancer Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Tumor Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0021 affected3 at risk EG003
Lethargy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Nervous System Disorder	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Neuropathy Peripheral	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Paresthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Depression	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Cystitis Non-infective	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Urinary Retention	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Dyspareunia	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Vulvovaginal Dryness	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0022 affected3 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Nasal Ulcer	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Rhinalgia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Upper Airway Cough Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Actinic Keratosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Hair Colour Changes	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Nail Disorder	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0021 affected3 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0021 affected3 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Sinus Operation	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected4 at risk EG0020 affected3 at risk EG003
Hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected4 at risk EG0020 affected3 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected3 at risk EG0012 affected4 at risk EG0020 affected3 at risk EG003

ID	Term
D013274	Stomach Neoplasms
D001749	Urinary Bladder Neoplasms
D004938	Esophageal Neoplasms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases
D006258	Head and Neck Neoplasms
D004935	Esophageal Diseases