Cilengitide (EMD 121974) for Recurrent Glioblastoma Multi... | NCT00093964

Label	Type	Description	Intervention Names
Cilengitide 500 Milligram (mg)	Experimental		Drug: Cilengitide 500 mg
Cilengitide 2000 mg	Experimental		Drug: Cilengitide 2000 mg

Name	Type	Description	Arm Group Labels	Other Names
Cilengitide 500 mg	Drug	Subjects will receive 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Measure	Description	Time Frame
Percentage of Subjects With Progression-free Survival	Progression-free survival was defined as subjects who survived greater than or equal to (>=) 180 days without disease progression. Disease progression was assessed as per independent central blinded radiology assessment.	Month 6

Measure	Description	Time Frame
Percentage of Subjects With Overall Response Rate	Overall response rate was defined as percentage of subjects who had best response during the study which was either complete response (CR: disappearance of all tumors, no new lesions and stable or improved neurological examination) or partial response (PR: >= reduction in the sum of the products of the largest perpendicular diameters compared to the baseline sum, no worsening of evaluable lesion and stable or improved neurological examination). CR or PR was confirmed within 31 days with a repeat neuroimaging.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent obtained before undergoing any study-related activities.
Males or females 18 years of age or older who can be treated in an outpatient setting.
Histologically proven GBM, which is recurrent or progressive following surgery or biopsy, external beam radiation therapy, and 1 previous regimen of systemic chemotherapy (Gliadel wafer therapy is not considered systemic chemotherapy). Malignancy is to be documented with a previous histopathological report.
Subjects initially diagnosed with other conditions similar to GBM (such as anaplastic astrocytoma [AA] or low grade glioma) that subsequently progressed to histologically proven GBM and have had surgery or biopsy, external beam radiation therapy, and 1 previous regimen of systemic chemotherapy for the original diagnosis are eligible if they meet all inclusion criteria.
GBM recurring only in the contralateral hemisphere must be histologically confirmed by biopsy. GBM recurring bilaterally does not need to be histologically confirmed by biopsy (i.e., if recurrence is ipsilateral and contralateral).
Archived tumor tissue specimens from the GBM surgery or biopsy must be available for central pathology review and exploratory analysis of angiogenic markers (e.g. αvβ3 and αvβ5 integrins).
Measurable disease (solid contrast-enhancing lesion greater than or equal to (>=)1 cm in any dimension) evaluated by gadolinium-enhanced magnetic resonance imaging (Gd MRI) within 2 weeks prior to the first dose of EMD 121974.
At least 12 weeks have elapsed since the last radiation treatment, and at least 4 weeks have elapsed since the last chemotherapy dose (at least 6 weeks for nitrosourea-containing chemotherapy) prior to the first dose of EMD 121974.
If the subject underwent recent surgery, status must be >=2 weeks post surgery or >=1 week post biopsy, in stable condition, and maintained on a stable corticosteroid regimen for >=5 days prior to first dose of EMD 121974.
Karnofsky Performance Score (KPS) of >=70%.
Subjects with the potential for pregnancy or impregnating their partner must agree to follow acceptable methods of birth control to avoid conception during the study and for at least 6 months after receiving the last dose of study drug.
Women of childbearing potential must have a negative pregnancy test at screening.
Laboratory values (within 1 week prior to the first dose of EMD 121974, except for blood count and Prothrombin time (PT)/Partial thromboplastin time (PTT), which are to be within 72 hours of the first dose): Absolute neutrophil count >=1500/millimeter (mm)^3. Platelets >=100,000/mm^3. Creatinine less than or equal to (<=) 1.5 milligram/deciliter (mg/dL) or creatinine clearance >=60 mL/min. Hematocrit >=30%. Prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits. Hemoglobin >=10 mg/dL. Total bilirubin <=1.5 times the upper limit of normal. Aspartate aminotransferase and alanine aminotransferase <=2.5 times above upper limit of normal.
No more than 8 weeks have elapsed since recurrence was detected

Exclusion Criteria:

Prior radiation therapy greater than (>) 66 Gray.
Subject anticipates undergoing elective surgery, dental extraction, or invasive dental procedures.
History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment.
History of prior malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for ≥5 years are eligible for this study.
History of coagulation disorder associated with bleeding or recurrent thrombotic events.
Concurrent illness, including severe infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety.
Subject is pregnant, anticipates becoming pregnant within 6 months after study participation, or is currently breast-feeding.
Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of EMD 121974.
Prior antiangiogenic therapy.
Placement of Gliadel wafer at surgery for recurrence.
Unable to undergo Gd MRI.
Current known alcohol dependence or drug abuse.
Requiring concomitant chemotherapy.
Treatment with a prohibited concomitant medication.
Known hypersensitivity to the study treatment.
Legal incapacity or limited legal capacity.

Name	Affiliation	Role
Medical Responsible	EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294-3280	United States
Barrow Neurological Institute

PubMed Identifier	Type	Citation	Retractions
18981465	Result	Reardon DA, Fink KL, Mikkelsen T, Cloughesy TF, O'Neill A, Plotkin S, Glantz M, Ravin P, Raizer JJ, Rich KM, Schiff D, Shapiro WR, Burdette-Radoux S, Dropcho EJ, Wittemer SM, Nippgen J, Picard M, Nabors LB. Randomized phase II study of cilengitide, an integrin-targeting arginine-glycine-aspartic acid peptide, in recurrent glioblastoma multiforme. J Clin Oncol. 2008 Dec 1;26(34):5610-7. doi: 10.1200/JCO.2008.16.7510. Epub 2008 Nov 3.

ID	Title	Description
FG000	Cilengitide 500 Milligram (mg)	Subjects received 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
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 Subjects With Progression-free Survival

Progression-free survival was defined as subjects who survived greater than or equal to (>=) 180 days without disease progression. Disease progression was assessed as per independent central blinded radiology assessment.

The intention-to-treat (ITT) population included all randomized subjects who had received at least 1 intravenous administration of cilengitide. Here,"Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure.

Posted

Number

95% Confidence Interval

percentage of subjects

Month 6

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Units	Counts
Participants	OG00040 OG00140

Title

Denominators

Categories

Title	Measurements
	OG0007.5(1.6 to 20.4) OG00115.0(5.7 to 29.8)

Secondary

Percentage of Subjects With Overall Response Rate

Overall response rate was defined as percentage of subjects who had best response during the study which was either complete response (CR: disappearance of all tumors, no new lesions and stable or improved neurological examination) or partial response (PR: >= reduction in the sum of the products of the largest perpendicular diameters compared to the baseline sum, no worsening of evaluable lesion and stable or improved neurological examination). CR or PR was confirmed within 31 days with a repeat neuroimaging.

ITT population included all randomized subjects who had received at least 1 intravenous administration of cilengitide. Here,"Number of participants analysed" signifies those subjects who were evaluable for this outcome measure.

Posted

Number

95% Confidence Interval

percentage of subjects

From the start of treatment up to 6 years

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Secondary

Time to Disease Progression

Time to disease progression was defined as the number of days between the first dose and the date of first assessment of progressive disease during the study or until death. Surviving subjects without progressive disease were censored at the time of the last visit and the subject was known to be non-progressing. Disease progression was assessed as per independent central blinded radiology assessment.

ITT population included all randomized subjects who had received at least 1 intravenous administration of cilengitide.

Posted

Median

Full Range

months

From the start of treatment until disease progression (assessed up to a maximum of 6 years)

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Secondary

Overall Survival Time

Survival time was defined as the number of months between the date of randomization and the date of death or the last date the subject was known to be alive.

ITT population included all randomized subjects who had received at least 1 intravenous administration of cilengitide.

Posted

Median

Full Range

months

From the start of treatment until death (assessed up to a maximum of 6 years)

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Units	Counts

Secondary

Percentage of Subjects With 1-year of Survival Rate

1-year survival rate was defined as percentage of subjects who survived for >=365 days with or without disease progression. Disease progression was assessed as per independent central blinded radiology assessment.

ITT population included all randomized subjects who had received at least 1 intravenous administration of cilengitide.

Posted

Number

95% Confidence Interval

percentage of subjects

From the start of treatment up to 1 year

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Secondary

Maximum Observed Plasma Concentration (Cmax)

Cmax is the maximum observed plasma concentration of cilengitide after administration.

The pharmacokinetic (PK) population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,"Overall Number of participants analyzed" = subjects evaluable for this outcome and "Number analyzed" = subjects evaluable for the specified category.

Posted

Mean

Standard Deviation

microgram per milliliter (mcg/mL)

Pre-dose, 1, 1.5, 2, 3, 4, 8, 24 hours post-infusion on Day 1 of Week 1 in Cycle 1 and 2

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Secondary

Time to Reach Maximum Plasma Concentration (Tmax)

Tmax is the time to reach the maximum plasma concentration (Cmax) of cilengitide.

The PK population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,"Overall Number of participants analyzed" = subjects evaluable for this outcome and "Number analyzed" = subjects evaluable for the specified category.

Posted

Median

Full Range

Hour (h)

Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity After Administration (AUC 0-infinity)

AUC 0-infinity is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration of cilengitide.

Posted

Mean

Standard Deviation

Microgram per milliliter*hour (mcg/mL*h)

Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Secondary

Apparent Terminal Rate Constant (Lambda z)

Lambda z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.

Posted

Mean

Standard Deviation

Per hour (/h)

Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Secondary

Terminal Half-life (t1/2)

The t1/2 is the time taken to eliminate half the amount of cilengitide.

Posted

Median

Full Range

Hour (h)

Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Secondary

Mean Residence Time of Drug in the Body (MRT)

MRT is defined as the mean duration of time a drug molecule is present in the systemic circulation.

Posted

Mean

Standard Deviation

Hour (h)

Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Secondary

Total Body Clearance (CL) of Drug From Plasma/Cerebro Spinal Fluid (CSF)

CL is a quantitative measure of the rate at which a drug substance is removed from the body, calculated as dose divided by AUC0-infinity.

Posted

Mean

Standard Deviation

Liter per hour (L/h)

Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Secondary

Apparent Volume of Distribution During the Terminal Phase (Vz)

Vz was calculated as Dose/(AUC0-infinity multiplied by elimination rate constant [lambda z]) following single dose.

The PK population included the subjects who had received cilengitide and who had had blood samples drawn in Week 1 and/or 5 that provided drug concentration for non-compartmental PK evaluation. Here, "Number of participants analysed" signifies those subjects who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

Liter (L)

Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Secondary

Apparent Volume of Distribution at Steady State (Vss)

Vss is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state.

The PK population included the subjects who had received cilengitide and who had blood samples drawn in Week 1 and/or 5 that provided drug concentration for non-compartmental PK evaluation. Here, "Number of participants analysed" signifies those subjects who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

Liter (L)

Pre-dose, 1, 1.5, 2, 3, 4, 8, 24 hours post-infusion on Day 1 of Week 1 in Cycle 1 and 2

ID	Title	Description
OG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Secondary

Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a subject which did not necessarily have a causal relationship with the study drug. A TEAE was any AE that started on or any time after the day of first dose of cilengitide during the treatment phase or within the safety follow-up after last dose of cilengitide. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly.

The safety population included all randomized subjects who had received at least 1 intravenous administration of cilengitide.

Posted

Number

subjects

From the start of treatment up to 6 years

ID	Title	Description
OG000	Cilengitide 500 Milligram (mg)	Subjects received 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
OG001	Cilengitide 2000 mg	Subjects received 1-hour intravenous infusion of 2000 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphopenia	Blood and lymphatic system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Diplopia	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Nausea	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Splenic artery aneurysm	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Vomiting	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Asthenia	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Chest pain	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Fatigue	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Gait disturbance	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Generalised oedema	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Oedema peripheral	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Aspergillosis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Brain abscess	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Cellulitis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Clostridium colitis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Herpes zoster	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Sepsis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Blood glucose increased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Amnesia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Aphasia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0013 affected40 at risk
Ataxia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Brain oedema	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Convulsion	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0005 affected41 at risk EG0018 affected40 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Headache	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0005 affected41 at risk EG0012 affected40 at risk
Hemiparesis	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Hemiplegia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Motor dysfunction	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Neurologic neglect syndrome	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Neuropathy	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Postictal paralysis	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Somnolence	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Affective disorder	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Confusional state	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Mental status changes	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Renal failure	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0013 affected40 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0012 affected40 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haemoglobinaemia	Blood and lymphatic system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0012 affected40 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Deafness	Ear and labyrinth disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0012 affected40 at risk
Middle ear effusion	Ear and labyrinth disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Cushingoid	Endocrine disorders	MedDRA 7.1	Non-systematic Assessment	EG0005 affected41 at risk EG0013 affected40 at risk
Hirsutism	Endocrine disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Cataract	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Conjunctivitis	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Diplopia	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0012 affected40 at risk
Dry eye	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Eye irritation	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Eye pain	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Eyelid oedema	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Gaze palsy	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Glaucoma	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Lacrimation increased	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Ophthalmoplegia	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Papilloedema	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Photophobia	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Scleral haemorrhage	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Vision blurred	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0005 affected41 at risk EG0013 affected40 at risk
Visual acuity reduced	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0005 affected41 at risk EG0011 affected40 at risk
Vitreous floaters	Eye disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0011 affected40 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0013 affected40 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Chapped lips	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Constipation	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0014 affected40 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0007 affected41 at risk EG0015 affected40 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0013 affected40 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Flatulence	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0010 affected40 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Gingival hypertrophy	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Gingivitis	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Lip disorder	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Lip dry	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Loose stools	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Nausea	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG00010 affected41 at risk EG0016 affected40 at risk
Stomach discomfort	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Toothache	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Vomiting	Gastrointestinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0012 affected40 at risk
Abasia	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Adverse drug reaction	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Asthenia	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0016 affected40 at risk
Catheter related complication	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Catheter site haemorrhage	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Catheter site oedema	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Catheter site pain	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0012 affected40 at risk
Chest discomfort	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Chest pain	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Chills	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Cyst	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0012 affected40 at risk
Difficulty in walking	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Facial pain	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Fatigue	General disorders	MedDRA 7.1	Non-systematic Assessment	EG00011 affected41 at risk EG00118 affected40 at risk
Gait disturbance	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected41 at risk EG0016 affected40 at risk
Influenza like illness	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Infusion site pain	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Infusion site reaction	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Malaise	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Mucosal inflammation	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Oedema	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Oedema peripheral	General disorders	MedDRA 7.1	Non-systematic Assessment	EG00012 affected41 at risk EG00110 affected40 at risk
Pitting oedema	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Pyrexia	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0013 affected40 at risk
Temperature intolerance	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Venipuncture site bruise	General disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Hypersensitivity	Immune system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Seasonal allergy	Immune system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Bacteriuria	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Body tinea	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Candidiasis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0012 affected40 at risk
Cellulitis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0012 affected40 at risk
Conjunctivitis infective	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Cystitis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Dental caries	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Eczema infected	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Eye infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Folliculitis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Gastroenteritis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Herpes simplex	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Herpes zoster	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Hordeolum	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Influenza	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Localised infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Nasopharyngitis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Oral infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Otitis externa	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Otitis media	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Respiratory tract infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Rhinitis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Sialoadenitis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Sinusitis	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0012 affected40 at risk
Tooth abscess	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0005 affected41 at risk EG0012 affected40 at risk
Urinary tract infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0004 affected41 at risk EG0013 affected40 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Blood blister	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0013 affected40 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0006 affected41 at risk EG0013 affected40 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Post procedural pain	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0013 affected40 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Tooth injury	Injury, poisoning and procedural complications	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Activated partial thromboplastin time shortened	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Alanine aminotransferase increased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0012 affected40 at risk
Anticonvulsant drug level increased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0012 affected40 at risk
Bacteria urine	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0010 affected40 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Blood cholesterol increased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Blood glucose increased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Blood iron decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Blood potassium decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Blood urea increased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Cardiac murmur	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Electrocardiogram ST segment elevation	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Electrocardiogram abnormal	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Haemoglobin decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Neutrophil count decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Neutrophil count increased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Nuclear magnetic resonance imaging abnormal	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Platelet count decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Prothrombin time	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Red blood cell count decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Tandem gait test abnormal	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Weight decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Weight increased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0012 affected40 at risk
White blood cell count decreased	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
White blood cells urine positive	Investigations	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0012 affected40 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0015 affected40 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected41 at risk EG0010 affected40 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Markedly reduced dietary intake	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Tetany	Metabolism and nutrition disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0009 affected41 at risk EG0012 affected40 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected41 at risk EG0018 affected40 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Muscle cramp	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0013 affected40 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0005 affected41 at risk EG0014 affected40 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Myopathy steroid	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0012 affected40 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Amnesia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0008 affected41 at risk EG0015 affected40 at risk
Aphasia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0005 affected41 at risk EG0019 affected40 at risk
Ataxia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0013 affected40 at risk
Aura	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Balance disorder	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0007 affected41 at risk EG0012 affected40 at risk
Brain oedema	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Cognitive disorder	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Convulsion	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0007 affected41 at risk EG0014 affected40 at risk
Coordination abnormal	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Cranial nerve disorder	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0012 affected40 at risk
Cranial neuropathy	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0011 affected40 at risk
Disturbance in attention	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0010 affected40 at risk
Dizziness	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0007 affected41 at risk EG0017 affected40 at risk
Dysarthria	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0011 affected40 at risk
Dysgeusia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Dysgraphia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Dyskinesia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Dysphasia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Facial palsy	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0013 affected40 at risk
Facial paresis	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0005 affected41 at risk EG0010 affected40 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Headache	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG00014 affected41 at risk EG00114 affected40 at risk
Hemianopia homonymous	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Hemiparesis	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0014 affected40 at risk
Hemiplegia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Hyperreflexia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0012 affected40 at risk
Lethargy	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Memory impairment	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected41 at risk EG0015 affected40 at risk
Motor dysfunction	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected41 at risk EG0012 affected40 at risk
Neurologic neglect syndrome	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Neuropathic pain	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Neuropathy	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Nystagmus	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0012 affected40 at risk
Paraesthesia	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0012 affected40 at risk
Partial seizures	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0013 affected40 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Pyramidal tract syndrome	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Reflex sympathetic dystrophy	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Sensory disturbance	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Simple partial seizures	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0012 affected40 at risk
Sinus headache	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Somnolence	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0012 affected40 at risk
Speech disorder	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected41 at risk EG0013 affected40 at risk
Tremor	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected41 at risk EG0014 affected40 at risk
Upper motor neurone lesion	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Visual field defect	Nervous system disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Affect lability	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Aggression	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Agitation	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Anxiety	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0013 affected40 at risk
Cognitive deterioration	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Confusional state	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0008 affected41 at risk EG0017 affected40 at risk
Depression	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0003 affected41 at risk EG0016 affected40 at risk
Disorientation	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Insomnia	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected41 at risk EG0016 affected40 at risk
Irritability	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Mental status changes	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Mood altered	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Nervousness	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Personality change	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0012 affected40 at risk
Psychomotor retardation	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Haematuria	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Leukocyturia	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Proteinuria	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected41 at risk EG0010 affected40 at risk
Renal salt-wasting syndrome	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 7.1	Non-systematic Assessment	EG0004 affected41 at risk EG0014 affected40 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Menstrual disorder	Reproductive system and breast disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Nipple pain	Reproductive system and breast disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Polymenorrhoea	Reproductive system and breast disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Sexual dysfunction	Reproductive system and breast disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0012 affected40 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0014 affected40 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0015 affected40 at risk
Hoarseness	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Snoring	Respiratory, thoracic and mediastinal disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected40 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Face oedema	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0006 affected41 at risk EG0017 affected40 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Skin fragility	Skin and subcutaneous tissue disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected40 at risk
Hypertension	Vascular disorders	MedDRA 7.1	Non-systematic Assessment	EG0001 affected41 at risk EG0010 affected40 at risk
Hypotension	Vascular disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0012 affected40 at risk
Petechiae	Vascular disorders	MedDRA 7.1	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected40 at risk
Phlebitis	Vascular disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk
Phlebitis superficial	Vascular disorders	MedDRA 7.1	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected40 at risk

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009375	Neoplasms, Glandular and Epithelial
D009380	Neoplasms, Nerve Tissue
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Title	Description
BG000	Cilengitide 500 Milligrams (mg)	Subjects received a 1-hour intravenous (i.v.) infusion of 500 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
BG001	Cilengitide 2000 mg	Subjects received a 1-hour intravenous (i.v.) infusion of 2000 mg cilengitide twice weekly on Days 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cilengitide 500 Milligram (mg)	Subjects received 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.			16	41	41	41
EG001	Cilengitide 2000 mg	Subjects received 1-hour intravenous infusion of 2000 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.			18	40	39	40