A Study of Hedgehog Pathway Inhibitor GDC-0449 in Patient... | NCT00968981

NCT00968981

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Intervention Names
A	Experimental	Drug: GDC-0449
B	Experimental	Drug: GDC-0449
C	Experimental	Drug: GDC-0449

Name	Type	Description	Arm Group Labels	Other Names
GDC-0449	Drug	Daily oral repeating dose	A
GDC-0449

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady-State for Both Total and Unbound GDC-0449		Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Number of Participants With Greater Than (>) 50 Percent (%) Decrease in Trough Concentration at Steady State (Css, Trough)	Percent change = ([trough concentration on Day 15 minus trough concentration on Day 57] divided by trough concentration on Day 15) multiplied by 100.	Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Ratio of Total and Unbound Trough GDC-0449 Concentration Between Day 57 to Day 15	Ratio = trough concentration on Day 57 divided by trough concentration on Day 15. If the ratio of total and unbound trough GDC-0449 concentration between Day 57 to Day 15 is less than 1, then it indicates reduction in total and unbound trough GDC-0449 concentration between Day 15 to Day 57.	Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Plasma Concentration at Steady State (Css) for Total and Unbound GDC-0449	Plasma GDC-0449 concentrations were reported in nanogram per milliliter (ng/mL) units and converted to micromolar (mcM) units using the molecular weight (421.30 grams per mole [g/mol]) prior to PK analysis. Css was calculated for Days 28 to 56.	Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Maximum Plasma Concentration (Cmax) of Total and Unbound GDC-0449	Plasma GDC-0449 concentrations were reported in ng/mL units and converted to mcM units using the molecular weight (421.30 g/mol) prior to PK analysis.

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Disease Progression or Death	Disease progression (assessed by Response Evaluation Criteria in Solid Tumors [RECIST]) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing non target lesions.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Histologically documented, incurable, locally advanced or metastatic solid malignancy that has progressed after first-line and second-line therapy (if there is a second-line therapy that has been shown to provide clinical benefit); patients with basal cell carcinoma will be excluded from this study unless they do not qualify for another open GDC-0449 clinical trial
For patients with disease that is evaluable by physical examination only, diagnosis must also include biomarker confirmation
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Documented negative pregnancy test for women of childbearing potential and agreement to use an effective form of contraception for the duration of the study
Adequate hematopoietic capacity
Adequate hepatic function
Adequate renal function
At least 3 weeks since last chemotherapy, investigational agent, radiation therapy, or major surgical procedure and recovery to pre-treatment baseline or stabilization of all treatment-related toxicities

Exclusion Criteria

Known, untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for ≥ 3 months
Active infection requiring intravenous (IV) antibiotics
Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis
Any medical condition or diagnosis that would likely impair absorption of an orally administered drug (e.g., gastrectomy, ileal bypass, chronic diarrhea, gastroparesis)
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications
Pregnant or lactating
Treatment with excluded medications, including strong CYP450 inhibitors and inducers

Contacts/Locations Module

Name	Affiliation	Role
Jennifer Low, M.D.	Genentech, Inc.	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28250200	Derived	Jia G, Chandriani S, Abbas AR, DePianto DJ, N'Diaye EN, Yaylaoglu MB, Moore HM, Peng I, DeVoss J, Collard HR, Wolters PJ, Egen JG, Arron JR. CXCL14 is a candidate biomarker for Hedgehog signalling in idiopathic pulmonary fibrosis. Thorax. 2017 Sep;72(9):780-787. doi: 10.1136/thoraxjnl-2015-207682. Epub 2017 Mar 1.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	GDC-0449 150 mg QD	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule once daily (QD) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
FG001	GDC-0449 150 mg TIW

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

All enrolled participants were included for baseline parameters.

Arm/Group Information

ID	Title	Description
BG000	GDC-0449 150 mg QD	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
BG001	GDC-0449 150 mg TIW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
BG002	GDC-0449 150 mg QW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00023 BG00122 BG00222 BG00367

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00052.9 OG00175.0 OG00240.0

Secondary

Percentage of Participants With a Response by Best Overall Response (BOR)

BOR was defined as the best overall response observed during the treatment period according to RECIST. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Efficacy Evaluable Population; only participants with measurable disease at baseline were included in the analysis.

Posted

Number

percentage of participants

Screening Day 57, and every 8 weeks thereafter up to 52 weeks

ID	Title	Description
OG000	GDC-0449 150 mg QD	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
OG001	GDC-0449 150 mg TIW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).

Secondary

Progression-Free Survival (PFS) Time

PFS defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by the investigator review of tumor assessments using RECIST, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).

Efficacy Evaluable Population.

Posted

Median

95% Confidence Interval

months

Screening Day 57, and every 8 weeks thereafter up to 52 weeks

ID	Title	Description
OG000	GDC-0449 150 mg QD	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
OG001	GDC-0449 150 mg TIW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
OG002	GDC-0449 150 mg QW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).

Primary

Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady-State for Both Total and Unbound GDC-0449

The PK Evaluable Population. Number of participants analyzed (N) is equal to (=) participants with baseline and at least one post-baseline assessment for this outcome; n = participants evaluable at specified time-points.

Posted

Median

Full Range

hours

Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57

ID	Title	Description
OG000	GDC-0449 150 mg QD	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
OG001	GDC-0449 150 mg TIW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
OG002	GDC-0449 150 mg QW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).

Primary

Number of Participants With Greater Than (>) 50 Percent (%) Decrease in Trough Concentration at Steady State (Css, Trough)

Percent change = ([trough concentration on Day 15 minus trough concentration on Day 57] divided by trough concentration on Day 15) multiplied by 100.

PK Evaluable Population. Here number of participants analyzed (N) = participants with baseline and at least 1 post baseline assessment for this outcome.

Posted

Number

participants

Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57

ID	Title	Description
OG000	GDC-0449 150 mg QD	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
OG001	GDC-0449 150 mg TIW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
OG002	GDC-0449 150 mg QW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).

Primary

Ratio of Total and Unbound Trough GDC-0449 Concentration Between Day 57 to Day 15

Ratio = trough concentration on Day 57 divided by trough concentration on Day 15. If the ratio of total and unbound trough GDC-0449 concentration between Day 57 to Day 15 is less than 1, then it indicates reduction in total and unbound trough GDC-0449 concentration between Day 15 to Day 57.

The PK Evaluable Population. N = participants who completed Day 57 of the study were included in this analysis.

Posted

Mean

Full Range

ratio

Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57

ID	Title	Description
OG000	GDC-0449 150 mg QD	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
OG001	GDC-0449 150 mg TIW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
OG002	GDC-0449 150 mg QW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).

Primary

Plasma Concentration at Steady State (Css) for Total and Unbound GDC-0449

Plasma GDC-0449 concentrations were reported in nanogram per milliliter (ng/mL) units and converted to micromolar (mcM) units using the molecular weight (421.30 grams per mole [g/mol]) prior to PK analysis. Css was calculated for Days 28 to 56.

PK Evaluable Population. N = participants with baseline and post baseline data available for measurement of Css at steady state.

Posted

Mean

Standard Deviation

mcM

Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57

ID	Title	Description
OG000	GDC-0449 150 mg QD	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
OG001	GDC-0449 150 mg TIW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
OG002	GDC-0449 150 mg QW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).

Primary

Maximum Plasma Concentration (Cmax) of Total and Unbound GDC-0449

Plasma GDC-0449 concentrations were reported in ng/mL units and converted to mcM units using the molecular weight (421.30 g/mol) prior to PK analysis.

PK Evaluable Population. 'n' signifies number of participants with data available at specified timepoint in each group.

Posted

Mean

Standard Deviation

mcM

0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1, 15 and 57 post-dose

ID	Title	Description
OG000	GDC-0449 150 mg QD	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
OG001	GDC-0449 150 mg TIW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
OG002	GDC-0449 150 mg QW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).

Primary

Area Under the Curve From Time Zero to 24 Hour (AUC0-24) for Total and Unbound GDC-0449

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). Below the limit of quantitation (BLQ) values at pre-dose were considered as zero for PK analysis.

PK Evaluable Population. n = number of participants with data available at specified timepoint in each group.

Posted

Mean

Standard Deviation

mcM*hour

Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57

ID	Title	Description
OG000	GDC-0449 150 mg QD	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
OG001	GDC-0449 150 mg TIW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
OG002	GDC-0449 150 mg QW

Primary

Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) for Total and Unbound GDC-0449

AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). BLQ values at pre-dose were considered as zero for PK analysis.

PK Evaluable Population. n = number of participants with data available at specified time point in each group.

Posted

Mean

Standard Deviation

mcM*hour

Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57

ID	Title	Description
OG000	GDC-0449 150 mg QD	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
OG001	GDC-0449 150 mg TIW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
OG002	GDC-0449 150 mg QW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).

Secondary

Duration of Response (DR)

DR during first line therapy is defined as the time from when response (complete response [CR] or partial response [PR]) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only be calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow up for progression of disease during first line therapy. CR: disappearance of all target lesions (TLs) with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters. PR: at least a 30% decrease in the sum of diameters of TLs, with reference to baseline sum diameters. DR was not calculated as only 1 responding participant reached their response at the last scheduled response assessment, hence follow-up data are not available.

Not Posted

Screening Day 57, and every 8 weeks thereafter up to 52 weeks

Participants

Primary

Time to Achieve Maximum Observed Plasma Concentration (Tmax) After a Single Dose of GDC-0449

PK Evaluable Population.

Posted

Median

Full Range

hours

0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1

ID	Title	Description
OG000	GDC-0449 150 mg: All Participants	All participants received single dose of GDC-0449 150 mg capsule orally on Day 1.

Units	Counts
Participants	OG00063

Title	Denominators

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	GDC-0449 150 mg QD	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).	6	20	19	20
EG001	GDC-0449 150 mg TIW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).	8	21	19	21
EG002	GDC-0449 150 mg QW	Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).	8	22	20	22

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Intestinal obstruction	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Constipation	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Jejunal ulcer	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Gait disturbance	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Pain	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Urosepsis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0012 affected21 at risk EG0020 affected22 at risk
Abdominal wall abscess	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Pneumonia	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Cystitis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Headache	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Spinal cord compression	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Mental status changes	Psychiatric disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Lymphoedema	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG00011 affected20 at risk EG0018 affected21 at risk EG0028 affected22 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0007 affected20 at risk EG0013 affected21 at risk EG0028 affected22 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected20 at risk EG0014 affected21 at risk EG0026 affected22 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected20 at risk EG0013 affected21 at risk EG0025 affected22 at risk
Constipation	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected20 at risk EG0012 affected21 at risk EG0024 affected22 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected20 at risk EG0011 affected21 at risk EG0022 affected22 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected20 at risk EG0011 affected21 at risk EG0021 affected22 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk EG0022 affected22 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected20 at risk EG0011 affected21 at risk EG0021 affected22 at risk
Ascites	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0010 affected21 at risk EG0023 affected22 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk EG0021 affected22 at risk
Flatulence	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk EG0021 affected22 at risk
Faeces hard	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Fatigue	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0008 affected20 at risk EG0018 affected21 at risk EG0029 affected22 at risk
Oedema peripheral	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected20 at risk EG0012 affected21 at risk EG0023 affected22 at risk
Pain	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0013 affected21 at risk EG0021 affected22 at risk
Early satiety	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Chest pain	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0012 affected21 at risk EG0021 affected22 at risk
Chills	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0012 affected21 at risk EG0021 affected22 at risk
Pyrexia	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0022 affected22 at risk
Asthenia	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Catheter site pain	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Gait disturbance	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Oedema	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Suprapubic pain	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Mucosal inflammation	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Non-cardiac chest pain	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Swelling	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0006 affected20 at risk EG0013 affected21 at risk EG0025 affected22 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected20 at risk EG0012 affected21 at risk EG0024 affected22 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected20 at risk EG0011 affected21 at risk EG0023 affected22 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0012 affected21 at risk EG0022 affected22 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0011 affected21 at risk EG0024 affected22 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected20 at risk EG0012 affected21 at risk EG0020 affected22 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk EG0022 affected22 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0006 affected20 at risk EG0016 affected21 at risk EG0025 affected22 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected20 at risk EG0013 affected21 at risk EG0024 affected22 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0012 affected21 at risk EG0020 affected22 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Weight decreased	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected20 at risk EG0014 affected21 at risk EG0025 affected22 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0015 affected21 at risk EG0022 affected22 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0014 affected21 at risk EG0022 affected22 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0012 affected21 at risk EG0023 affected22 at risk
Alanine aminotransferase increased	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0011 affected21 at risk EG0022 affected22 at risk
Blood creatinine increased	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Blood chloride decreased	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Body temperature increased	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Breath sounds abnormal	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
White blood cell count increased	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected20 at risk EG0015 affected21 at risk EG0024 affected22 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0016 affected21 at risk EG0024 affected22 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk EG0022 affected22 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk EG0021 affected22 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Dizziness	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected20 at risk EG0012 affected21 at risk EG0023 affected22 at risk
Headache	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0013 affected21 at risk EG0023 affected22 at risk
Dysgeusia	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected20 at risk EG0014 affected21 at risk EG0020 affected22 at risk
Hypogeusia	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Sinus headache	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0010 affected21 at risk EG0022 affected22 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Poor quality sleep	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected20 at risk EG0014 affected21 at risk EG0022 affected22 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0012 affected21 at risk EG0021 affected22 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Paratracheal lymphadenopathy	Blood and lymphatic system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Urinary tract infection	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0013 affected21 at risk EG0022 affected22 at risk
Candidiasis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Infection	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0012 affected21 at risk EG0020 affected22 at risk
Oral herpes	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0010 affected21 at risk EG0022 affected22 at risk
Pneumonia	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0010 affected21 at risk EG0022 affected22 at risk
Herpes zoster	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Skin candida	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Depression	Psychiatric disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0012 affected21 at risk EG0021 affected22 at risk
Insomnia	Psychiatric disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0011 affected21 at risk EG0023 affected22 at risk
Anxiety	Psychiatric disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Confusional state	Psychiatric disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0012 affected21 at risk EG0020 affected22 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk EG0021 affected22 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Subcutaneous nodule	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Dysuria	Renal and urinary disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk EG0021 affected22 at risk
Chromaturia	Renal and urinary disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0012 affected21 at risk EG0020 affected22 at risk
Haematuria	Renal and urinary disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Urinary retention	Renal and urinary disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Hypotension	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected20 at risk EG0011 affected21 at risk EG0020 affected22 at risk
Hypertension	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0021 affected22 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Lymphoedema	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0012 affected21 at risk EG0023 affected22 at risk
Drug toxicity	Injury, poisoning and procedural complications	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Tachycardia	Cardiac disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0012 affected21 at risk EG0021 affected22 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Conjunctivitis	Eye disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Photopsia	Eye disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Visual impairment	Eye disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Jaundice	Hepatobiliary disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0012 affected21 at risk EG0020 affected22 at risk
Ear congestion	Ear and labyrinth disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0010 affected21 at risk EG0020 affected22 at risk

ID	Term
D002280	Carcinoma, Basal Cell

ID	Term
C538724	HhAntag691

Units	Counts
Participants	OG00015 OG00118 OG00218

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018295	Neoplasms, Basal Cell