Derazantinib and Atezolizumab in Patients With Urothelial... | NCT04045613

ID	Type	Description	Link
2019-000359-15	EudraCT Number

Label	Type	Description	Intervention Names
Substudy 1: Derazantinib 300 mg once daily	Experimental	Patients with urothelial cancer were treated with derazantinib 300 mg once daily	Drug: Derazantinib 300 mg once daily monotherapy
Substudy 2 (Dose-Level 1): Derazantinib 200 mg once daily + atezolizumab 1200 mg	Experimental	Patients with any solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as intravenous (IV) infusion	Drug: Derazantinib 200 mg once daily + atezolizumab 1200 mg
Substudy 2 (Dose-Level 2): Derazantinib 300 mg once daily + atezolizumab 1200 mg	Experimental	Patients with any solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion	Drug: Derazantinib 300 mg once daily+ atezolizumab 1200 mg
Substudy 3: Derazantinib 200 mg twice daily + atezolizumab 1200 mg	Experimental	Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion	Drug: Derazantinib 200 mg twice daily + atezolizumab 1200 mg
Substudy 4 (Cohort 4a):Derazantinib 300 mg once daily

Name	Type	Description	Arm Group Labels	Other Names
Derazantinib 300 mg once daily monotherapy	Drug	Derazantinib was administered orally at a dose of 300 mg once daily	Substudy 1: Derazantinib 300 mg once daily

Measure	Description	Time Frame
Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5)	ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1	From first dose up to 2 years
Recommended Phase 2 Dose (RP2D) of Derazantinib-atezolizumab in Combination Based on DLT Criteria, Safety and Efficacy Data (Substudy 2)	The RP2D was determined by a joint decision taken by the Independent Data Monitoring Committee (IDMC), Investigators, and the Sponsor in reviewing the aggregate of DLT and AE data, and considering efficacy data	From first dose up to 2 years
Number of Patients With Dose-limiting Toxicities (DLTs) in Substudy 2	In Substudy 2, the primary endpoint was the number of patients with DLTs. A DLT was defined as a clinically-significant adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications. Any DLT had to be a toxicity considered at least possibly related to derazantinib or the combination of derazantinib and atezolizumab	From first dose up to 2 years

Measure	Description	Time Frame
Disease Control Rate (DCR) Per RECIST 1.1 in All Substudies	DCR was defined as the proportion of patients who achieved a confirmed clinical response (CR), partial response (PR) or stable disease (SD) by BICR using the internationally recognized criteria in accordance with RECIST Version 1.1	From first dose up to 2 years

Name	Affiliation	Role
Manuel Häckl, MD	Basilea Pharmaceutica International Ltd, Allschwil	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
CTCA Clinical Research Inc., Atlanta		Newnan	Georgia	30265	United States
Englander Institute Weill Cornell Medicine

PubMed Identifier	Type	Citation	Retractions
38627238	Derived	Necchi A, Ramlau R, Falcon Gonzalez A, Chaudhry A, Todenhofer T, Tahbaz R, Fontana E, Giannatempo P, Deville JL, Pouessel D, Yoon S, Powles T, Bernat M, Hackl M, Marszewska M, McKernan P, Saulay M, Scaleia F, Engelhardt M, Loriot Y, Siefker-Radtke A, De Santis M. Derazantinib alone and with atezolizumab in metastatic urothelial carcinoma with activating FGFR aberrations. JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae030. doi: 10.1093/jncics/pkae030.

ID	Title	Description
FG000	Substudy 1: Derazantinib 300 mg Once Daily	Patients with urothelial cancer were treated with derazantinib 300 mg once daily Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
FG001	Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily + Atezolizumab 1200 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 8, 2021	Aug 9, 2023

Arm/Group Information

ID	Title	Description
BG000	Substudy 1: Derazantinib 300 mg Once Daily	Patients with urothelial cancer were treated with derazantinib 300 mg once daily Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
BG001	Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily+ Atezolizumab 1200 mg	Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 200 mg once daily+ atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
BG002	Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily+ Atezolizumab 1200 mg	Patients with solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 300 mg once daily+ atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
BG003	Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg	Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
BG004	Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily	Patients with urothelial cancer were treated with derazantinib 300 mg once daily Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
BG005	Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg	Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
BG006	Substudy 5: Derazantinib 200 mg Twice Daily	Patients with urothelial cancer were treated with derazantinib 200 mg twice daily Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily
BG007	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

Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5)

ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1

Efficacy analyses were performed using the modified Intent-to-Treat (mITT) population: all patients who received at least one dose of derazantinib or atezolizumab, and had at least one post-baseline imaging assessment in accordance with RECIST 1.1, or documented clinical progression

Posted

Number

95% Confidence Interval

Percentage of participants

From first dose up to 2 years

ID	Title	Description
OG000	Substudy 1: Derazantinib 300 mg Once Daily	Patients with urothelial cancer were treated with derazantinib 300 mg once daily Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
OG001	Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg	Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
OG002	Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily	Patients with urothelial cancer were treated with derazantinib 300 mg once daily Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
OG003	Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg	Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
OG004	Substudy 5: Derazantinib 200 mg Twice Daily	Patients with urothelial cancer were treated with derazantinib 200 mg twice daily Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily

Units	Counts
Participants	OG00032 OG0012 OG0027 OG003

Title

Denominators

Categories

Title	Measurements
	OG0009.4(2.0 to 25.0) OG0010.0(0.0 to 84.2) OG00214.3(0.4 to 57.9) OG003

Primary

Recommended Phase 2 Dose (RP2D) of Derazantinib-atezolizumab in Combination Based on DLT Criteria, Safety and Efficacy Data (Substudy 2)

The RP2D was determined by a joint decision taken by the Independent Data Monitoring Committee (IDMC), Investigators, and the Sponsor in reviewing the aggregate of DLT and AE data, and considering efficacy data

The safety/intent-to-treat (ITT) population consisted of all patients who received at least one dose of derazantinib or atezolizumab

Posted

Number

From first dose up to 2 years

ID	Title	Description
OG000	Substudy 2 Combined (Dose-Level 1 and 2): Derazantinib 200 or 300 Once Daily+ Atezolizumab 1200 mg	Patients with solid tumors were treated with derazantinib 200 mg or 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Units	Counts
Participants	OG000

Primary

Number of Patients With Dose-limiting Toxicities (DLTs) in Substudy 2

In Substudy 2, the primary endpoint was the number of patients with DLTs. A DLT was defined as a clinically-significant adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications. Any DLT had to be a toxicity considered at least possibly related to derazantinib or the combination of derazantinib and atezolizumab

The maximum tolerated dose (MTD)-determining population included all patients enrolled in the MTD Part of each dose level who met the following minimum criteria during the DLT period:

received at least one dose of derazantinib and atezolizumab and has experienced a DLT;
received ≥ 90% of the derazantinib and atezolizumab dose, respectively, in Cycle 1 and did not experience a DLT, have been observed for ≥ 21 days following the first dose, and have been evaluated for safety

Posted

Number

participants

From first dose up to 2 years

ID	Title	Description
OG000	Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily + Atezolizumab 1200 mg	Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 200 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
OG001	Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg

Secondary

Disease Control Rate (DCR) Per RECIST 1.1 in All Substudies

DCR was defined as the proportion of patients who achieved a confirmed clinical response (CR), partial response (PR) or stable disease (SD) by BICR using the internationally recognized criteria in accordance with RECIST Version 1.1

Posted

Number

95% Confidence Interval

Percentage of participants

From first dose up to 2 years

ID	Title	Description
OG000	Substudy 1: Derazantinib 300 mg Once Daily	Patients with urothelial cancer were treated with derazantinib 300 mg once daily Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
OG001	Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily + Atezolizumab 1200 mg	Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 200 mg once daily+ atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Secondary

Duration of Response (DOR) Per RECIST 1.1

DOR was calculated from the first date of documented tumor response (confirmed CR or PR) to the date of disease progression as assessed by BICR or death per RECIST 1.1

Posted

Median

95% Confidence Interval

months

From first dose up to 2 years

ID	Title	Description
OG000	Substudy 1: Derazantinib 300 mg Once Daily	Patients with urothelial cancer were treated with derazantinib 300 mg once daily Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
OG001	Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily+ Atezolizumab 1200 mg	Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 200 mg once daily+ atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
OG002	Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily+ Atezolizumab 1200 mg

Secondary

ORR Based on RECIST 1.1 (Substudy 2)

Posted

Number

95% Confidence Interval

Percentage of participants

From first dose up to 2 years

ID	Title	Description
OG000	Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily + Atezolizumab 1200 mg	Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 200 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
OG001	Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg	Patients with solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 300 mg once daily+ atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Secondary

Progression-free Survival (PFS) by RECIST in All Substudies

PFS was calculated as the time from cohort assignment until disease progression as assessed by BICR, or death from any cause, whichever came first

Posted

Median

95% Confidence Interval

months

From first dose up to 2 years

ID	Title	Description
OG000	Substudy 1: Derazantinib 300 mg Once Daily	Patients with urothelial cancer were treated with derazantinib 300 mg once daily Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
OG001	Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily + Atezolizumab 1200 mg	Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 200 mg once daily+ atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
OG002	Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily+ Atezolizumab 1200 mg

Secondary

Overall Survival (OS) in All Substudies

OS was calculated from the date of cohort assignment until death from any cause

Posted

Median

95% Confidence Interval

months

From first dose up to 2 years

ID	Title	Description
OG000	Substudy 1: Derazantinib 300 mg Once Daily	Patients with urothelial cancer were treated with derazantinib 300 mg once daily Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
OG001	Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily + Atezolizumab 1200 mg	Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 200 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
OG002	Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily+ Atezolizumab 1200 mg

Secondary

Number of Patients With at Least Grade 3 Adverse Events (AEs)

Common Terminology Criteria for Adverse Events (CTCAE) displayed by increasing severity grades 3 to 5 (CTCAE grade 3/4/5 )

The safety/intent-to-treat (ITT) population consisted of all patients who received at least one dose of derazantinib or atezolizumab

Posted

Count of Participants

Participants

From first dose and until 90 days following the last dose

ID	Title	Description
OG000	Substudy 1: Derazantinib 300 mg Once Daily	Patients with urothelial cancer were treated with derazantinib 300 mg once daily Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily
OG001	Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily+ Atezolizumab 1200 mg	Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 200 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
OG002	Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg

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	Substudy 1: Derazantinib 300 mg Once Daily	Patients with urothelial cancer were treated with derazantinib 300 mg once daily Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily	8	32	17	32	30	32
EG001	Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily + Atezolizumab 1200 mg	Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 200 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks	3	14	4	14	14	14
EG002	Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg	Patients with solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks	3	12	6	12	12	12
EG003	Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg	Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks	1	2	1	2	2	2
EG004	Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily	Patients with urothelial cancer were treated with derazantinib 300 mg once daily Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily	0	8	3	8	8	8
EG005	Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg	Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks	4	10	6	10	10	10
EG006	Substudy 5: Derazantinib 200 mg Twice Daily	Patients with urothelial cancer were treated with derazantinib 200 mg twice daily Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily	1	17	8	17	17	17

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Alanine aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG0030 affected2 at risk EG0040 affected8 at risk EG0052 affected10 at risk EG0060 affected17 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Blood creatinine increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Eastern Cooperative Oncology Group performance status worsened	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Nephritis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Hypercalcaemia of malignancy	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Cachexia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Endocarditis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Oral fungal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Embolism	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Disease progression	General disorders	MedDRA 22.0	Systematic Assessment	EG0007 affected32 at risk EG0012 affected14 at risk EG0023 affected12 at risk EG003
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Hypothermia	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Hepatic cytolysis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Alanine aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG00010 affected32 at risk EG0012 affected14 at risk EG0025 affected12 at risk EG0030 affected2 at risk EG0042 affected8 at risk EG0052 affected10 at risk EG0065 affected17 at risk
Amylase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0004 affected32 at risk EG0011 affected14 at risk EG0022 affected12 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG00012 affected32 at risk EG0012 affected14 at risk EG0023 affected12 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0004 affected32 at risk EG0011 affected14 at risk EG0022 affected12 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Blood creatinine increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0006 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0004 affected32 at risk EG0011 affected14 at risk EG0022 affected12 at risk EG003
Blood phosphorus increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0004 affected32 at risk EG0010 affected14 at risk EG0024 affected12 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
C-reactive protein increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0004 affected32 at risk EG0011 affected14 at risk EG0021 affected12 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Lipase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0004 affected32 at risk EG0012 affected14 at risk EG0021 affected12 at risk EG003
Platelet count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Transaminases increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Weight decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0003 affected32 at risk EG0012 affected14 at risk EG0020 affected12 at risk EG003
Palpitations	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0007 affected32 at risk EG0012 affected14 at risk EG0022 affected12 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected32 at risk EG0012 affected14 at risk EG0021 affected12 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Dizziness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected32 at risk EG0012 affected14 at risk EG0020 affected12 at risk EG003
Sciatica	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Tremor	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Cataract	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Central serous chorioretinopathy	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Dry eye	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Keratitis	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Maculopathy	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Punctate keratitis	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Vision blurred	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Xerophthalmia	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0012 affected14 at risk EG0020 affected12 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0011 affected14 at risk EG0022 affected12 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0022 affected12 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00010 affected32 at risk EG0011 affected14 at risk EG0021 affected12 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0007 affected32 at risk EG0014 affected14 at risk EG0023 affected12 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0007 affected32 at risk EG0011 affected14 at risk EG0022 affected12 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected14 at risk EG0021 affected12 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00014 affected32 at risk EG0016 affected14 at risk EG0024 affected12 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0006 affected32 at risk EG0014 affected14 at risk EG0023 affected12 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected14 at risk EG0021 affected12 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Nail dystrophy	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected32 at risk EG0011 affected14 at risk EG0022 affected12 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Cachexia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0009 affected32 at risk EG0013 affected14 at risk EG0023 affected12 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0014 affected14 at risk EG0020 affected12 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0012 affected14 at risk EG0020 affected12 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0012 affected14 at risk EG0020 affected12 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0011 affected14 at risk EG0021 affected12 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0011 affected14 at risk EG0020 affected12 at risk EG003
Lymphoedema	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Asthenia	General disorders	MedDRA 22.0	Systematic Assessment	EG0008 affected32 at risk EG0012 affected14 at risk EG0025 affected12 at risk EG003
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG0008 affected32 at risk EG0015 affected14 at risk EG0022 affected12 at risk EG003
Mucosal inflammation	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0022 affected12 at risk EG003
Oedema	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003
Oedema peripheral	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected14 at risk EG0022 affected12 at risk EG003
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected14 at risk EG0023 affected12 at risk EG003
Hepatic cytolysis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0020 affected12 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected14 at risk EG0021 affected12 at risk EG003

ID	Term
D002295	Carcinoma, Transitional Cell
D001749	Urinary Bladder Neoplasms
D000168	Acrocephalosyndactylia

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
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
D003398	Craniosynostoses
D013580	Synostosis
D004413	Dysostoses
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D013576	Syndactyly
D019465	Craniofacial Abnormalities
D009139	Musculoskeletal Abnormalities
D017880	Limb Deformities, Congenital
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities