A Safety Study in Participants With Advanced Solid Tumors | NCT01284335

ID	Type	Description	Link
H8K-MC-JZAK	Other Identifier	Eli Lilly and Company

Label	Type	Intervention Names
Gemcitabine plus LY573636	Experimental	Drug: Gemcitabine Drug: LY573636
Docetaxel plus LY573636	Experimental	Drug: Docetaxel Drug: LY573636
Temozolomide plus LY573636	Experimental	Drug: Temozolomide Drug: LY573636
Cisplatin plus LY573636	Experimental	Drug: Cisplatin Drug: LY573636
Erlotinib plus LY573636	Experimental	Drug: Erlotinib Drug: LY573636

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine	Drug	1000 mg/m2 administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.

Measure	Description	Time Frame
Number of Participants With Dose-Limiting Toxicities Cycle 1	A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade 4 neutropenia lasting more than 5 days. Grade 4 neutropenia with fever or Grade 4 thrombocytopenia, regardless of duration; Grade ≥3 thrombocytopenia with bleeding, regardless of duration; Grade ≥3 nonhematologic toxicity (excluding nausea/vomiting or diarrhea that can be controlled with medication, and alopecia). Grade 3 electrolyte toxicity (for example, hypokalemia, hypophosphatemia) will not be considered a DLT unless it is considered related to the study drug or combination and does not resolve with standard replacement treatments within 42 days after Cycle 1 Day 1. A summary of other nonserious AEs and all Serious Adverse Events (SAE), regardless of causality is located in the Reported Adverse Event section.	Baseline to Cycle 1 (Up to Day 28)

Measure	Description	Time Frame
Pharmacokinetic (PK): Concentration Maximum (Cmax)	Cycle 2: predose,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.	Cycle 1: predose,0,30min,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.
Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)

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

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Birmingham	Alabama	35233

PubMed Identifier	Type	Citation	Retractions
25260842	Derived	Jotte RM, Von Hoff DD, Braiteh F, Becerra CR, Richards DA, Smith DA, Garbo L, Stephenson J, Conkling PR, Robert-Vizcarrondo F, Chen J, Turner PK, Chow KH, Tai DF, Ilaria R Jr. An innovative, multi-arm, complete phase 1b study of the novel anti-cancer agent tasisulam in patients with advanced solid tumors. Invest New Drugs. 2015 Feb;33(1):148-58. doi: 10.1007/s10637-014-0160-z. Epub 2014 Sep 28.

ID	Title	Description
FG000	Arm A Tasisulam + Gemcitabine Dose Escalation	Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met. Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.

Arm/Group Information

ID	Title	Description
BG000	Arm A Tasisulam + Gemcitabine Dose Escalation	Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met. Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
BG001	Arm A Tasisulam + Gemcitabine Dose Confirmation	Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met. Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
BG002	Arm B* Tasisulam + Docetaxel Dose Escalation	Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
BG003	Arm B1 Tasisulam + Docetaxel Dose Escalation	Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met. Tasisulam Day 4 of a 28 day cycle. Participant's may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
BG004	Arm B2 Tasisulam + Docetaxel Dose Escalation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
BG005	Arm B2 Tasisulam + Docetaxel Dose Confirmation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
BG006	Arm C Tasisulam + Temozolomide Dose Escalation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
BG007	Arm C Tasisulam + Temozolomide Dose Confirmation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
BG008	Arm D* Tasisulam + Cisplatin Dose Escalation	Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
BG009	Arm D Tasisulam + Cisplatin Dose Escalation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
BG010	Arm D Tasisulam + Cisplatin Dose Confirmation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
BG011	Arm E Tasisulam + Erlotinib Dose Escalation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
BG012	Arm E Tasisulam + Erlotinib Dose Confirmation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
BG013	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 Dose-Limiting Toxicities Cycle 1

A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade 4 neutropenia lasting more than 5 days. Grade 4 neutropenia with fever or Grade 4 thrombocytopenia, regardless of duration; Grade ≥3 thrombocytopenia with bleeding, regardless of duration; Grade ≥3 nonhematologic toxicity (excluding nausea/vomiting or diarrhea that can be controlled with medication, and alopecia). Grade 3 electrolyte toxicity (for example, hypokalemia, hypophosphatemia) will not be considered a DLT unless it is considered related to the study drug or combination and does not resolve with standard replacement treatments within 42 days after Cycle 1 Day 1. A summary of other nonserious AEs and all Serious Adverse Events (SAE), regardless of causality is located in the Reported Adverse Event section.

All participants who received at least one dose of study drug Tasisulam in dose escalation phase and experienced a dose-limiting toxicity.

Posted

Count of Participants

Participants

Baseline to Cycle 1 (Up to Day 28)

ID	Title	Description
OG000	Arm A Tasisulam + Gemcitabine Dose Escalation	Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met. Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
OG001	Arm A Tasisulam + Gemcitabine Dose Confirmation	Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met. Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
OG002	Arm B* Tasisulam + Docetaxel Dose Escalation	Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
OG003	Arm B1 Tasisulam + Docetaxel Dose Escalation	Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met. Tasisulam Day 4 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
OG004	Arm B2 Tasisulam + Docetaxel Dose Escalation

Units	Counts
Participants	OG00025 OG00133 OG0025 OG003

Title

Denominators

Categories

Title	Measurements
	OG0004 OG0010 OG0024 OG003

Secondary

Pharmacokinetic (PK): Concentration Maximum (Cmax)

Cycle 2: predose,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.

All participants who received at least one dose of study drug Tasisulam and had evaluable PK data

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms per milliliter (µg/mL)

Cycle 1: predose,0,30min,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.

ID	Title	Description
OG000	Tasisulam	Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion are met.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)

Best overall tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions.

All participants who received study drug Tasisulam and had CR or PR tumor response at dose confirmation phase.

Posted

Number

90% Confidence Interval

percentage of participants

Baseline to Study Completion (Up to 2 years)

ID	Title	Description
OG000	Arm A Tasisulam + Gemcitabine Dose Confirmation	Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met. Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
OG001	Arm B* Tasisulam + Docetaxel Dose Confirmation	Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.

Secondary

Number of Participants With a Clinically Significant Effects

Clinically significant effects are reported if a Grade 3 or higher treatment emergent adverse event (TEAE) and observed in ≥10% of participants or a toxicity possibly related to study drug based on Common Terminology Criteria for Adverse Events (CTCAE). A summary of other nonserious AEs and all SAEs, regardless of causality is located in the Reported Adverse Event section.

All participants who received at least one dose of study drug Tasisulam and experienced a Grade 3 or higher TEAE or drug toxicity possibly related to study drug.

Posted

Count of Participants

Participants

Baseline to Study Completion (Up to 2 years)

ID	Title	Description
OG000	Arm A Tasisulam + Gemcitabine Dose Escalation	Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met. Tasisulam dose is dependent on participants height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
OG001	Arm A Tasisulam + Gemcitabine Dose Confirmation	Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met. Tasisulam dose is dependent on participants height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.

Secondary

PK: Area Under the Curve Albumin (AUCalb)

Cycle 2: predose,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.

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

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms*hour/milliliter (µg*h/mL)

Cycle 1: predose,0,30min,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.

ID	Title	Description
OG000	Tasisulam	Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters

Units	Counts
Participants	OG000

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	Arm A Tasisulam + Gemcitabine Dose Escalation	Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met. Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.	2	25	9	25	24	25
EG001	Arm A Tasisulam + Gemcitabine Dose Confirmation	Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met. Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.	8	33	14	33	33	33
EG002	Arm B* Tasisulam + Docetaxel Dose Escalation	Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.	1	5	1	5	5	5
EG003	Arm B1 Tasisulam + Docetaxel Dose Escalation	Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met. Tasisulam Day 4 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.	1	5	2	5	5	5
EG004	Arm B2 Tasisulam + Docetaxel Dose Escalation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.	0	24	9	24	24	24
EG005	Arm B2 Tasisulam + Docetaxel Dose Confirmation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.	4	26	12	26	26	26
EG006	Arm C Tasisulam + Temozolomide Dose Escalation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met	3	19	8	19	19	19
EG007	Arm C Tasisulam + Temozolomide Dose Confirmation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.	3	6	4	6	6	6
EG008	Arm D* Tasisulam + Cisplatin Dose Escalation	Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.	1	4	1	4	4	4
EG009	Arm D Tasisulam+ Cisplatin Dose Escalation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.	2	14	4	14	14	14
EG010	Arm D Tasisulam+ Cisplatin Dose Confirmation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.	7	45	19	45	43	45
EG011	Arm E Tasisulam + Erlotinib Dose Escalation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.	3	16	6	16	16	16
EG012	Arm E Tasisulam + Erlotinib Dose Confirmation	Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.	3	12	7	12	11	12

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0004 events2 affected25 at risk EG0013 events2 affected33 at risk EG0020 events0 affected5 at risk EG0030 events0 affected5 at risk EG0045 events1 affected24 at risk EG0050 events0 affected26 at risk EG0061 events1 affected19 at risk EG0070 events0 affected6 at risk EG0080 events0 affected4 at risk EG0090 events0 affected14 at risk EG0104 events3 affected45 at risk EG0110 events0 affected16 at risk EG0120 events0 affected12 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0013 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events1 affected14 at risk EG0020 events0 affected2 at risk EG003
Adrenal haemorrhage	Endocrine disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0013 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Jejunal ulcer	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Oesophageal obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0005 events2 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Asthenia	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Complication associated with device	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
General physical health deterioration	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Mucosal inflammation	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Oedema peripheral	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0003 events2 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Bile duct obstruction	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Cellulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Endocarditis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0021 events1 affected5 at risk EG003
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pseudomonal bacteraemia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Septic shock	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Systemic candida	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Acute haemolytic transfusion reaction	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Platelet count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Aphasia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Dizziness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Presyncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Seizure	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Vasogenic cerebral oedema	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Obstructive uropathy	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0021 events1 affected5 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0014 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0021 events1 affected5 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00066 events11 affected25 at risk EG00128 events13 affected33 at risk EG0025 events3 affected5 at risk EG00311 events4 affected5 at risk EG00445 events11 affected24 at risk EG00582 events11 affected26 at risk EG00621 events6 affected19 at risk EG0074 events2 affected6 at risk EG0080 events0 affected4 at risk EG00913 events5 affected14 at risk EG01071 events19 affected45 at risk EG01127 events8 affected16 at risk EG01214 events4 affected12 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00011 events4 affected25 at risk EG0010 events0 affected33 at risk EG0021 events1 affected5 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00048 events13 affected25 at risk EG00130 events7 affected33 at risk EG0025 events4 affected5 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00041 events12 affected25 at risk EG00128 events11 affected33 at risk EG0021 events1 affected5 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Palpitations	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0016 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Chorioretinal disorder	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Dry eye	Eye disorders	MedDRA 19.0	Systematic Assessment	EG00014 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Eye discharge	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Eye pain	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0025 events1 affected5 at risk EG003
Macular detachment	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Orbital oedema	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Periorbital oedema	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Vision blurred	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0004 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Visual impairment	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0018 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0014 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00022 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00011 events4 affected25 at risk EG0019 events5 affected33 at risk EG0020 events0 affected5 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0004 events2 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00026 events7 affected25 at risk EG00164 events16 affected33 at risk EG0027 events1 affected5 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00022 events13 affected25 at risk EG00151 events9 affected33 at risk EG0024 events2 affected5 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0014 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 events1 affected25 at risk EG0018 events1 affected33 at risk EG0022 events1 affected5 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0005 events3 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG00111 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected25 at risk EG00112 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Large intestinal stenosis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Lip ulceration	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0004 events2 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00050 events10 affected25 at risk EG00142 events7 affected33 at risk EG0023 events3 affected5 at risk EG003
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Oral discomfort	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected33 at risk EG0021 events1 affected5 at risk EG003
Pancreatic insufficiency	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0006 events4 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0005 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00013 events6 affected25 at risk EG0014 events3 affected33 at risk EG0023 events2 affected5 at risk EG003
Application site dermatitis	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Asthenia	General disorders	MedDRA 19.0	Systematic Assessment	EG00012 events5 affected25 at risk EG00114 events4 affected33 at risk EG0020 events0 affected5 at risk EG003
Chest discomfort	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Chest pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected33 at risk EG0021 events1 affected5 at risk EG003
Chills	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0013 events3 affected33 at risk EG0023 events2 affected5 at risk EG003
Decreased activity	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Discomfort	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Face oedema	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG00076 events17 affected25 at risk EG00190 events17 affected33 at risk EG00211 events3 affected5 at risk EG003
Feeling hot	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Gait disturbance	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0021 events1 affected5 at risk EG003
Influenza like illness	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Infusion site pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0012 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Injection site pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Malaise	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0021 events1 affected5 at risk EG003
Mucosal inflammation	General disorders	MedDRA 19.0	Systematic Assessment	EG00011 events6 affected25 at risk EG0019 events4 affected33 at risk EG0023 events1 affected5 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Oedema	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG00111 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Oedema peripheral	General disorders	MedDRA 19.0	Systematic Assessment	EG0007 events4 affected25 at risk EG00113 events3 affected33 at risk EG0026 events2 affected5 at risk EG003
Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0016 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Peripheral swelling	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0005 events5 affected25 at risk EG00126 events5 affected33 at risk EG0025 events2 affected5 at risk EG003
Temperature intolerance	General disorders	MedDRA 19.0	Systematic Assessment	EG0003 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Thirst	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Xerosis	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0003 events1 affected25 at risk EG0015 events3 affected33 at risk EG0020 events0 affected5 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG00110 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Angular cheilitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Bronchitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Candida infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0013 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Cellulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Cystitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Fungal infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Localised infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Nail infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Oral herpes	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0013 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected33 at risk EG0022 events1 affected5 at risk EG003
Pseudomonal bacteraemia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Sinusitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 events2 affected25 at risk EG0015 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0004 events2 affected25 at risk EG0014 events3 affected33 at risk EG0020 events0 affected5 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0007 events6 affected25 at risk EG0014 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Viral infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected19 at risk EG0020 events0 affected3 at risk EG003
Vulvovaginitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected19 at risk EG0020 events0 affected3 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0004 events3 affected25 at risk EG0012 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0015 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Blood creatine increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Blood creatinine increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0009 events3 affected25 at risk EG0015 events3 affected33 at risk EG0022 events2 affected5 at risk EG003
Blood urea increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Blood urine present	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Carbon dioxide decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0021 events1 affected5 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0015 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
International normalised ratio increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Platelet count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Precancerous cells present	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Prothrombin time prolonged	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Urine leukocyte esterase	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Weight decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG00013 events5 affected25 at risk EG00117 events5 affected33 at risk EG0020 events0 affected5 at risk EG003
Weight increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0007 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
White blood cell count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0006 events2 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG00022 events7 affected25 at risk EG00127 events6 affected33 at risk EG0020 events0 affected5 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG00010 events4 affected25 at risk EG0012 events2 affected33 at risk EG0021 events1 affected5 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0005 events3 affected25 at risk EG0016 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0009 events3 affected25 at risk EG00113 events6 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG00013 events7 affected25 at risk EG00115 events4 affected33 at risk EG0021 events1 affected5 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0003 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0003 events2 affected25 at risk EG0014 events3 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG00011 events5 affected25 at risk EG0015 events3 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0004 events3 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00023 events4 affected25 at risk EG0019 events1 affected33 at risk EG0023 events1 affected5 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00014 events5 affected25 at risk EG0015 events4 affected33 at risk EG0020 events0 affected5 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0007 events2 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00019 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0019 events3 affected33 at risk EG0020 events0 affected5 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0014 events2 affected33 at risk EG0023 events1 affected5 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0006 events2 affected25 at risk EG0010 events0 affected33 at risk EG0022 events1 affected5 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00010 events3 affected25 at risk EG0017 events1 affected33 at risk EG0023 events1 affected5 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0005 events3 affected25 at risk EG0018 events1 affected33 at risk EG0022 events1 affected5 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Amnesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Dizziness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0011 events1 affected33 at risk EG0021 events1 affected5 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0004 events2 affected25 at risk EG00137 events8 affected33 at risk EG0020 events0 affected5 at risk EG003
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00013 events3 affected25 at risk EG0012 events2 affected33 at risk EG0025 events4 affected5 at risk EG003
Lethargy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0007 events3 affected25 at risk EG00118 events2 affected33 at risk EG0021 events1 affected5 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0019 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Speech disorder	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Syncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Device occlusion	Product Issues	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected25 at risk EG00114 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Depression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0007 events2 affected25 at risk EG00111 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Disorientation	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0021 events1 affected5 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG00014 events4 affected25 at risk EG0016 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Stress	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Bladder pain	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0005 events3 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Ureteric obstruction	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Urinary hesitation	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0003 events2 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0018 events2 affected14 at risk EG0020 events0 affected2 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected14 at risk EG0020 events0 affected2 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events1 affected19 at risk EG0020 events0 affected3 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0004 events2 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00011 events4 affected25 at risk EG00143 events11 affected33 at risk EG0025 events2 affected5 at risk EG003
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00029 events9 affected25 at risk EG00135 events9 affected33 at risk EG0023 events1 affected5 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00015 events4 affected25 at risk EG0015 events2 affected33 at risk EG0021 events1 affected5 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0015 events3 affected33 at risk EG0023 events1 affected5 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG00114 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0007 events3 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0025 events1 affected5 at risk EG003
Nasal mucosal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0005 events4 affected25 at risk EG00113 events4 affected33 at risk EG0025 events3 affected5 at risk EG003
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0004 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0021 events1 affected5 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0015 events2 affected33 at risk EG0021 events1 affected5 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00012 events2 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0014 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0025 events2 affected5 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0018 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0014 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00010 events3 affected25 at risk EG00128 events6 affected33 at risk EG0026 events1 affected5 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0008 events1 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0019 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hirsutism	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected19 at risk EG0020 events0 affected3 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events2 affected33 at risk EG0021 events1 affected5 at risk EG003
Nail bed inflammation	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0022 events1 affected5 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0003 events1 affected25 at risk EG0014 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0008 events2 affected25 at risk EG00110 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0005 events2 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Flushing	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected33 at risk EG0023 events1 affected5 at risk EG003
Haematoma	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0025 events1 affected5 at risk EG003
Hot flush	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0007 events1 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0009 events7 affected25 at risk EG0012 events2 affected33 at risk EG0020 events0 affected5 at risk EG003
Pallor	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Phlebitis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0012 events1 affected33 at risk EG0020 events0 affected5 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003
Vasodilatation	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected33 at risk EG0020 events0 affected5 at risk EG003

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000093542	Gemcitabine
D000077143	Docetaxel
D000077204	Temozolomide
D002945	Cisplatin
D000069347	Erlotinib Hydrochloride
C534068	N-((5-bromo-2-thienyl)sulfonyl)-2,4-dichlorobenzamide

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D003606	Dacarbazine
D014226	Triazenes
D007093	Imidazoles
D001393	Azoles
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring