Study of CP-751,871 in Combination With Docetaxel and Pre... | NCT00313781

Label	Type	Description	Intervention Names
A	Experimental	For patients treated with docetaxel and prednisone only, who progress during treatment, CP-751,871 will be added to the regimen to test reversibility of chemoresistance.	Drug: CP-751,871 Drug: docetaxel Drug: prednisone
B	Active Comparator		Drug: docetaxel Drug: prednisone

Name	Type	Description	Arm Group Labels	Other Names
CP-751,871	Drug	CP-750,871 is administered intravenously at a dose of 20 mg/kg on day 1 of each 21-day cycle (for patient convenience and logistical management, the dose of CP-751,871 may be deferred up to 7 days).

Measure	Description	Time Frame
Percentage of Participants With Prostate Specific Antigen (PSA) Best Response	Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as >= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.	Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS was defined as the time from randomization to first event of disease progression. Disease progression events were defined as the following: PSA progression,objective disease progression as per RECIST, death, and discontinuation of treatment due to symptomatic deterioration. PSA progression was defined as the time-point of PSA progression on 2 successive evaluations taken 1 week apart after dosing in cycle 3.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Los Angeles	California	90048	United States
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
24536060	Derived	de Bono JS, Piulats JM, Pandha HS, Petrylak DP, Saad F, Aparicio LM, Sandhu SK, Fong P, Gillessen S, Hudes GR, Wang T, Scranton J, Pollak MN. Phase II randomized study of figitumumab plus docetaxel and docetaxel alone with crossover for metastatic castration-resistant prostate cancer. Clin Cancer Res. 2014 Apr 1;20(7):1925-34. doi: 10.1158/1078-0432.CCR-13-1869. Epub 2014 Feb 17.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion intravenously (IV) over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21 days cycle, up to 17 cycles.
FG001

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

Percentage of Participants With Prostate Specific Antigen (PSA) Best Response

Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as >= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.

Response-evaluable population: All enrolled participants who had a baseline PSA reference value and received at least one dose of assigned treatment with the exception of those participants without symptomatic or objective progression (participants with PSA progression only) who withdraw consent prior to Cycle 3.

Posted

Mean

90% Confidence Interval

Percentage of participants

Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)

ID	Title	Description
OG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
OG001	Docetaxel+Prednisone	Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
OG002	Docetaxel+Prednisone+CP-751,871 Crossover	Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.

Units	Counts
Participants	OG00087 OG00198 OG00232

Title

Denominators

Categories

Title	Measurements
	OG00051.7(42.4 to 61.0) OG00160.2(51.4 to 68.5) OG00228.1(15.5 to 43.9)

Secondary

Progression Free Survival (PFS)

PFS was defined as the time from randomization to first event of disease progression. Disease progression events were defined as the following: PSA progression,objective disease progression as per RECIST, death, and discontinuation of treatment due to symptomatic deterioration. PSA progression was defined as the time-point of PSA progression on 2 successive evaluations taken 1 week apart after dosing in cycle 3.

Full analysis set included all participants who were enrolled into the study and received at least one assigned treatment.

Posted

Median

95% Confidence Interval

Months

Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)

ID	Title	Description
OG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
OG001	Docetaxel+Prednisone	Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
OG002	Docetaxel+Prednisone+CP-751,871 Crossover

Secondary

Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)

Levels of HAHA in serum were detected at baseline.

All participants who were enrolled in the study, received at least one assigned treatment and had available HAHA assessment.

Posted

Mean

Standard Deviation

mg/deciliter (dl)

Baseline (Day 1 of Cycle 1)

ID	Title	Description
OG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
OG001	Docetaxel+Prednisone	Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.

Units	Counts
Participants	OG000

Secondary

Human Anti-human Antibody (HAHA) at the Last Follow-up Visit

Levels of HAHA in serum were detected at the last follow-up visit.

All participants who were enrolled in the study, received at least one assigned treatment and had HAHA available assessment.

Posted

Mean

Standard Deviation

mg/dl

The last follow-up visit (150 days post last dose)

ID	Title	Description
OG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
OG001	Docetaxel+Prednisone	Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
OG002	Docetaxel+Prednisone+CP-751,871 Crossover	Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.

Secondary

Population PK Parameters of CP-751,871

Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-751,871 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-751,871 concentrations

Not Posted

Mean

Standard Deviation

ng/mL

Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

Secondary

Total Number of Circulation Tumor Cells (CTCs)

Blood samples were collected and processed to enumerate the number of total CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive epithelial cell adhesion molecule (EpCAM) and cytokeratin staining.

Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.

Posted

Mean

Standard Deviation

Number of CTCs/7.5 mL

Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)

ID	Title	Description
OG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
OG001	Docetaxel+Prednisone	Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.

Units	Counts
Participants

Secondary

Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs

Blood samples were collected to enumerate the number of total IGF-1R positive CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive EpCAM and cytokeratin staining. A separate CellSave tube of cells was also collected and processed with cell surface staining of IGF-1R to enumerate surfaces of IGF-1R-positive CTCs.

Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.

Posted

Mean

Standard Deviation

Number of IGF-1R positive CTCs/7.5 mL

Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)

ID	Title	Description
OG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
OG001	Docetaxel+Prednisone	Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.

Secondary

Quality of Life Measured by the Functional Assessment of Cancer Treatment-Prostate (FACT-P)

The FACT-P was a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The total FACT-P score ranged from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represented the best outcome.

The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the patient reported outcome (PRO) summary irrelevant 2) lack of resources as the program was terminated.

Posted

Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)

ID	Title	Description
OG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
OG001	Docetaxel+Prednisone	Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.

Secondary

Pain Measured by the Modified Brief Pain Inventory-Short Form (mBPI-sf Modified Pfizer)

The mBPI-sf was a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the worst pain item of the mBPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an "X" in one of the 10 boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuraxial block.

The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the PRO summary irrelevant 2) lack of resources as the program was terminated.

Posted

Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)

ID	Title	Description
OG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
OG001	Docetaxel+Prednisone	Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.

Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871

Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration.

The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.

Posted

Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

ID	Title	Description
OG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
OG001	Docetaxel+Prednisone+CP-751,871 Crossover	Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.

Units	Counts
Participants

Secondary

Maximum Observed Plasma Concentration (Cmax) for CP-751,871

The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.

Posted

Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

ID	Title	Description
OG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
OG001	Docetaxel+Prednisone+CP-751,871 Crossover	Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.

Units	Counts
Participants	OG000

Secondary

Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871

The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.

Posted

Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

ID	Title	Description
OG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
OG001	Docetaxel+Prednisone+CP-751,871 Crossover	Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.

Units	Counts
Participants	OG000

Secondary

Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871

The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.

Posted

Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

ID	Title	Description
OG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
OG001	Docetaxel+Prednisone+CP-751,871 Crossover	Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG00012 affected97 at risk EG0017 affected102 at risk EG0022 affected37 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG00010 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Cardiac failure	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Myocardial infarction	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Hypercalcaemia of malignancy	Endocrine disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Asthenia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Chest pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Death	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Disease progression	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected97 at risk EG0013 affected102 at risk EG0026 affected37 at risk
Drug interaction	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Fatigue	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0010 affected102 at risk EG0023 affected37 at risk
Pyrexia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Hypersensitivity	Immune system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Abscess	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Candidiasis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Cellulitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Clostridial infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Diverticulitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Gastrointestinal fungal infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Localised infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0013 affected102 at risk EG0020 affected37 at risk
Peridiverticular abscess	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0014 affected102 at risk EG0022 affected37 at risk
Salmonellosis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Septic shock	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Soft tissue infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Blood creatinine increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Troponin T increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Weight decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG00011 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Cerebral infarction	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Cognitive disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Convulsion	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Lethargy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Mental impairment	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Presyncope	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Speech disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Spinal cord compression	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Syncope	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Confusional state	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Major depression	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Mental status changes	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Suicide attempt	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Renal impairment	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Urinary retention	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0022 affected37 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Haematoma	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Hypotension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Vasculitis	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG00013 affected97 at risk EG00121 affected102 at risk EG00211 affected37 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG00022 affected97 at risk EG00124 affected102 at risk EG0024 affected37 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected97 at risk EG00110 affected102 at risk EG0024 affected37 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG00034 affected97 at risk EG00137 affected102 at risk EG00210 affected37 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Bradycardia	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Cardiac failure	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Coronary artery disease	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Extrasystoles	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Mitral valve prolapse	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Palpitations	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Tachycardia	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Deafness	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Deafness bilateral	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Ear disorder	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Ear haemorrhage	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Cushingoid	Endocrine disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0013 affected102 at risk EG0020 affected37 at risk
Hypothyroidism	Endocrine disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Blepharitis	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Cataract	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Conjunctival pallor	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Conjunctivitis	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected97 at risk EG0015 affected102 at risk EG0022 affected37 at risk
Dry eye	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Ectropion	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Eye haemorrhage	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Eye pain	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Eye pruritus	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Keratoconjunctivitis sicca	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Lacrimation increased	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected97 at risk EG0018 affected102 at risk EG0026 affected37 at risk
Ocular hyperaemia	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Periorbital oedema	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Photophobia	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Retinal detachment	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Retinal disorder	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Scleral haemorrhage	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Vision blurred	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0015 affected102 at risk EG0022 affected37 at risk
Visual impairment	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected97 at risk EG0012 affected102 at risk EG0023 affected37 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Anal inflammation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Anorectal disorder	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Colitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00022 affected97 at risk EG00117 affected102 at risk EG0028 affected37 at risk
Defaecation urgency	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Dental caries	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00064 affected97 at risk EG00138 affected102 at risk EG00214 affected37 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected97 at risk EG0014 affected102 at risk EG0023 affected37 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected97 at risk EG0016 affected102 at risk EG0023 affected37 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0013 affected102 at risk EG0022 affected37 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0012 affected102 at risk EG0022 affected37 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Flatulence	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0022 affected37 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Gastritis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Gastrointestinal oedema	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Gingival ulceration	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0022 affected37 at risk
Gingivitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0013 affected102 at risk EG0022 affected37 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Melaena	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00034 affected97 at risk EG00128 affected102 at risk EG00210 affected37 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Oral pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0014 affected102 at risk EG0021 affected37 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0012 affected102 at risk EG0023 affected37 at risk
Proctitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Rectal discharge	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Rectal fissure	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00010 affected97 at risk EG0016 affected102 at risk EG0022 affected37 at risk
Rectal tenesmus	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Sensitivity of teeth	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Steatorrhoea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00018 affected97 at risk EG0018 affected102 at risk EG0023 affected37 at risk
Tongue disorder	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Tongue oedema	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Tooth loss	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Toothache	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00019 affected97 at risk EG00112 affected102 at risk EG00210 affected37 at risk
Vomiting projectile	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Asthenia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00038 affected97 at risk EG00133 affected102 at risk EG00213 affected37 at risk
Catheter site pruritus	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Chest discomfort	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0014 affected102 at risk EG0021 affected37 at risk
Chest pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0013 affected102 at risk EG0022 affected37 at risk
Chills	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected97 at risk EG0016 affected102 at risk EG0023 affected37 at risk
Death	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Device occlusion	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Discomfort	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Disease progression	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Energy increased	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Extravasation	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Face oedema	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Fatigue	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00040 affected97 at risk EG00136 affected102 at risk EG00214 affected37 at risk
Feeling cold	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Feeling hot	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Gait disturbance	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0012 affected102 at risk EG0022 affected37 at risk
General physical health deterioration	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0022 affected37 at risk
Influenza like illness	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Infusion site pruritus	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Injection site reaction	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Irritability	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Local swelling	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Malaise	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0013 affected102 at risk EG0020 affected37 at risk
Mucosal dryness	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Mucosal inflammation	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00015 affected97 at risk EG00112 affected102 at risk EG0021 affected37 at risk
Oedema	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0022 affected37 at risk
Oedema peripheral	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00010 affected97 at risk EG00128 affected102 at risk EG0024 affected37 at risk
Pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected97 at risk EG0013 affected102 at risk EG0024 affected37 at risk
Premature ageing	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Pyrexia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00012 affected97 at risk EG00113 affected102 at risk EG0024 affected37 at risk
Sensation of pressure	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Temperature intolerance	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Therapeutic response unexpected	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Thirst	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Ulcer	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Jaundice	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Allergic oedema	Immune system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Hypersensitivity	Immune system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Anorectal infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Bronchitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Candidiasis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0013 affected102 at risk EG0020 affected37 at risk
Catheter site cellulitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Cellulitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Conjunctivitis infective	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Device related infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Diverticulitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Ear infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Gastric infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Genital candidiasis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Gingival infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Herpes virus infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Herpes zoster	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0013 affected102 at risk EG0021 affected37 at risk
Infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Influenza	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Localised infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Lung infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Nail infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0014 affected102 at risk EG0020 affected37 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG00111 affected102 at risk EG0024 affected37 at risk
Onychomycosis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0015 affected102 at risk EG0022 affected37 at risk
Oral candidiasis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0014 affected102 at risk EG0020 affected37 at risk
Oral herpes	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Oral viral infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Paronychia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Parotitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Pharyngitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0013 affected102 at risk EG0022 affected37 at risk
Rhinitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0016 affected102 at risk EG0022 affected37 at risk
Sepsis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Septic shock	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Sinusitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Skin infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Soft tissue infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Tinea pedis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Tooth infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0016 affected102 at risk EG0020 affected37 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG00012 affected97 at risk EG0017 affected102 at risk EG0022 affected37 at risk
Viral infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Wound infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Chemical injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG0014 affected102 at risk EG0022 affected37 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0009 affected97 at risk EG0010 affected102 at risk EG0023 affected37 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Nail injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Splinter	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Superficial injury of eye	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Alanine aminotransferase	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Alanine aminotransferase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Aspartate aminotransferase	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Blood albumin decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Blood alkaline phosphatase	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0014 affected102 at risk EG0023 affected37 at risk
Blood amylase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Blood bicarbonate decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Blood bilirubin increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Blood creatinine increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0009 affected97 at risk EG0010 affected102 at risk EG0022 affected37 at risk
Blood glucose	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Blood glucose abnormal	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Blood glucose increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0013 affected102 at risk EG0023 affected37 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Blood magnesium decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Blood magnesium increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Blood phosphorus	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Blood potassium decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Blood potassium increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Blood sodium decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Blood urea increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0011 affected102 at risk EG0022 affected37 at risk
Blood uric acid increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0013 affected102 at risk EG0021 affected37 at risk
General physical condition abnormal	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Granulocyte count decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Haemoglobin	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Haemoglobin decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
International normalised ratio abnormal	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
International normalised ratio increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Lipase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Lymphocyte count	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Lymphocyte count decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Murphy's sign positive	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Neutrophil count decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Neutrophil count increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Platelet count	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Platelet count decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Platelet count increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Renal function test abnormal	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Troponin increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Weight decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG00018 affected97 at risk EG0018 affected102 at risk EG0026 affected37 at risk
Weight increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0013 affected102 at risk EG0021 affected37 at risk
White blood cell count	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
White blood cell count decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0013 affected102 at risk EG0020 affected37 at risk
White blood cell count increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Central obesity	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG00056 affected97 at risk EG00132 affected102 at risk EG00220 affected37 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Hyperalbuminaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0022 affected37 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG00034 affected97 at risk EG00115 affected102 at risk EG00214 affected37 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0013 affected102 at risk EG0021 affected37 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0014 affected102 at risk EG0021 affected37 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG0014 affected102 at risk EG0022 affected37 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Polydipsia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00010 affected97 at risk EG00115 affected102 at risk EG00210 affected37 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00020 affected97 at risk EG00113 affected102 at risk EG00211 affected37 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0017 affected102 at risk EG0021 affected37 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0012 affected102 at risk EG0022 affected37 at risk
Joint stiffness	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0012 affected102 at risk EG0022 affected37 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00019 affected97 at risk EG0017 affected102 at risk EG0026 affected37 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00013 affected97 at risk EG00111 affected102 at risk EG0026 affected37 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0013 affected102 at risk EG0023 affected37 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00014 affected97 at risk EG0018 affected102 at risk EG0025 affected37 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected97 at risk EG00113 affected102 at risk EG0024 affected37 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Neck mass	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0015 affected102 at risk EG0021 affected37 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00014 affected97 at risk EG00118 affected102 at risk EG00210 affected37 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Upper extremity mass	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Benign neoplasm of testis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Ageusia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0013 affected102 at risk EG0021 affected37 at risk
Amnesia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0011 affected102 at risk EG0022 affected37 at risk
Aphonia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Ataxia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Balance disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Burning sensation	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Cognitive disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Dementia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Disturbance in attention	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00010 affected97 at risk EG00116 affected102 at risk EG0026 affected37 at risk
Dizziness exertional	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Dizziness postural	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Drooling	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Dysarthria	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Dysgeusia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00037 affected97 at risk EG00137 affected102 at risk EG00212 affected37 at risk
Extrapyramidal disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Headache	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected97 at risk EG0017 affected102 at risk EG0021 affected37 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0018 affected102 at risk EG0022 affected37 at risk
Hypogeusia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Lethargy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00015 affected97 at risk EG00116 affected102 at risk EG0025 affected37 at risk
Loss of consciousness	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Memory impairment	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Migraine	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Monoparesis	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Nervous system disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00016 affected97 at risk EG00122 affected102 at risk EG00212 affected37 at risk
Neurotoxicity	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected97 at risk EG0013 affected102 at risk EG0020 affected37 at risk
Paraesthesia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG00115 affected102 at risk EG0025 affected37 at risk
Paraparesis	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0015 affected102 at risk EG0024 affected37 at risk
Polyneuropathy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Presyncope	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Sciatica	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Sleep phase rhythm disturbance	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Somnolence	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Speech disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Spinal cord compression	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0022 affected37 at risk
Syncope	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0014 affected102 at risk EG0021 affected37 at risk
Tremor	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Aggression	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Agitation	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Anxiety	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Bradyphrenia	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Confusional state	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Delirium	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Depressed mood	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0013 affected102 at risk EG0021 affected37 at risk
Depression	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG0011 affected102 at risk EG0022 affected37 at risk
Disorientation	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Euphoric mood	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Hallucination	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Insomnia	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected97 at risk EG00112 affected102 at risk EG0021 affected37 at risk
Listless	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Mental disorder	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Mood swings	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Nervousness	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Personality change	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Restlessness	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Sleep disorder	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Anuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Azotaemia	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Bladder spasm	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Dysuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0013 affected102 at risk EG0022 affected37 at risk
Enuresis	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG0013 affected102 at risk EG0023 affected37 at risk
Haemoglobinuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Incontinence	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Micturition disorder	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Nocturia	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected97 at risk EG0019 affected102 at risk EG0024 affected37 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0014 affected102 at risk EG0022 affected37 at risk
Polyuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0010 affected102 at risk EG0022 affected37 at risk
Proteinuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0013 affected102 at risk EG0023 affected37 at risk
Renal impairment	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Urinary hesitation	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG0014 affected102 at risk EG0023 affected37 at risk
Urinary retention	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Urinary tract disorder	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Urine flow decreased	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0022 affected37 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Pelvic discomfort	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0014 affected102 at risk EG0023 affected37 at risk
Penile pain	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Perineal pain	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Prostatic pain	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Scrotal oedema	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00015 affected97 at risk EG00113 affected102 at risk EG0025 affected37 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG00111 affected102 at risk EG0021 affected37 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00015 affected97 at risk EG00123 affected102 at risk EG00210 affected37 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0013 affected102 at risk EG0023 affected37 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00021 affected97 at risk EG00115 affected102 at risk EG0027 affected37 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Hypopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Lower respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0013 affected102 at risk EG0020 affected37 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0016 affected102 at risk EG0021 affected37 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0022 affected37 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0015 affected102 at risk EG0020 affected37 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Rhinalgia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected97 at risk EG0015 affected102 at risk EG0022 affected37 at risk
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00046 affected97 at risk EG00151 affected102 at risk EG00217 affected37 at risk
Blood blister	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected97 at risk EG00114 affected102 at risk EG0024 affected37 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0010 affected102 at risk EG0022 affected37 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected97 at risk EG00110 affected102 at risk EG0022 affected37 at risk
Hair colour changes	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0021 affected37 at risk
Hair disorder	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0013 affected102 at risk EG0022 affected37 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Hypoaesthesia facial	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Macule	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Nail bed bleeding	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Nail bed disorder	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0012 affected102 at risk EG0020 affected37 at risk
Nail discomfort	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG00115 affected102 at risk EG0027 affected37 at risk
Nail toxicity	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected97 at risk EG0016 affected102 at risk EG0020 affected37 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0013 affected102 at risk EG0021 affected37 at risk
Onychalgia	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected97 at risk EG0016 affected102 at risk EG0021 affected37 at risk
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Precancerous skin lesion	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected97 at risk EG0014 affected102 at risk EG0022 affected37 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0010 affected102 at risk EG0022 affected37 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected97 at risk EG0017 affected102 at risk EG0022 affected37 at risk
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Skin atrophy	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Skin discomfort	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Skin fragility	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0023 affected37 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0010 affected102 at risk EG0024 affected37 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Denture wearer	Social circumstances	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Capillary fragility	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Flushing	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0018 affected102 at risk EG0021 affected37 at risk
Haematoma	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected97 at risk EG0012 affected102 at risk EG0021 affected37 at risk
Hot flush	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0016 affected102 at risk EG0020 affected37 at risk
Hypertension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected97 at risk EG0014 affected102 at risk EG0022 affected37 at risk
Hypotension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected97 at risk EG0015 affected102 at risk EG0021 affected37 at risk
Intermittent claudication	Surgical and medical procedures	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk
Intra-abdominal haematoma	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Pallor	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected97 at risk EG0011 affected102 at risk EG0023 affected37 at risk
Peripheral embolism	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected97 at risk EG0010 affected102 at risk EG0021 affected37 at risk
Phlebitis	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0010 affected102 at risk EG0020 affected37 at risk
Thrombosis	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected97 at risk EG0011 affected102 at risk EG0020 affected37 at risk

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
BG001	Docetaxel+Prednisone	Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.	64	97	96	97
EG001	Docetaxel+Prednisone	Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.	37	102	53	102
EG002	Docetaxel+Prednisone+CP-751,871 Crossover	Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.	20	37	21	37