Study Evaluating The Safety, Efficacy & Pharmacokinetics... | NCT00494091

ID	Type	Description	Link
B1771002

Label	Type	Description	Intervention Names
A.	Experimental		Drug: Temsirolimus (CCI-779)
B.	Experimental		Drug: Temsirolimus (CCI-779)

Name	Type	Description	Arm Group Labels	Other Names
Temsirolimus (CCI-779)	Drug	20 mg/m2 IV TEMSR weekly (Japan, n=6)	A.

Measure	Description	Time Frame
Percentage of Participants With Clinical Benefit	Clinical benefit: confirmed complete response (CR) or partial response (PR) or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and nontarget lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).	Baseline Up to 4 years

Measure	Description	Time Frame
Progression-free Survival (PFS)	Median time from the date of enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.	Baseline Up to 4 years
Percentage of Participants With Objective Response

Measure	Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.	0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Nanjing	Jiangsu	210002	China
Pfizer Investigational Site

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

ID	Title	Description
FG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
FG001	Temsirolimus 25 mg

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 Clinical Benefit

Clinical benefit: confirmed complete response (CR) or partial response (PR) or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and nontarget lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).

Intent-to-treat (ITT) population included all participants who were enrolled in this study.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline Up to 4 years

ID	Title	Description
OG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Temsirolimus 25 mg	Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG0006 OG00176

Title

Denominators

Categories

Title	Measurements
	OG00050.0(11.8 to 88.2) OG00148.7(37.0 to 60.4)

Secondary

Progression-free Survival (PFS)

Median time from the date of enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

ITT population included all participants who were enrolled in this study.

Posted

Median

95% Confidence Interval

months

Baseline Up to 4 years

ID	Title	Description
OG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Temsirolimus 25 mg	Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Objective Response

Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria In Solid Tumors (RECIST). CR is disappearance of all target lesions. PR shows at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

ITT population included all participants who were enrolled in this study.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline Up to 4 years

ID	Title	Description
OG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Temsirolimus 25 mg	Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000

Secondary

Duration of Response

Time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest sum longest diameters (LD) recorded since enrollment.

Intent-to-treat ITT population included all participants who were enrolled in this study. Here N (number of participants analyzed) signifies participants with objective disease response.

Posted

Median

95% Confidence Interval

months

Baseline Up to 4 years

ID	Title	Description
OG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Temsirolimus 25 mg	Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000

Secondary

Time to Treatment Failure (TTF)

TTF is defined as the time from the date of enrollment to the date of the first documentation of PD, the date of treatment discontinuation except completion of treatment, or date of death due to cancer.

ITT population included all participants who were enrolled in this study.

Posted

Median

95% Confidence Interval

months

Baseline Up to 4 years

ID	Title	Description
OG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Temsirolimus 25 mg	Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS)

Time in months from the date of enrollment to date of death due to any cause. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

ITT population included all participants who were enrolled in this study.

Posted

Median

95% Confidence Interval

months

Baseline Until Death (Up to 4 years)

ID	Title	Description
OG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Temsirolimus 25 mg IV	Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000

Other Pre-specified

Maximum Observed Plasma Concentration (Cmax)

Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.

Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Mean

Standard Deviation

nanogram per milliliter (ng/mL)

0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment

ID	Title	Description
OG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000

Other Pre-specified

Time to Reach Maximum Observed Plasma Concentration (Tmax)

PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Median

Full Range

hours

0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment

ID	Title	Description
OG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000

Other Pre-specified

Plasma Decay Half-Life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.

Posted

Mean

Standard Deviation

hours

0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment

ID	Title	Description
OG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000

Other Pre-specified

Area Under the Concentration-Time Curve (AUC)

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.

Posted

Mean

Standard Deviation

ng*h/mL

0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment

ID	Title	Description
OG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000

Other Pre-specified

Clearance (CLss) of Temsirolimus

Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of temsirolimus (R0/Css). As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.

Posted

Mean

Standard Deviation

Liter per hour (L/h)

0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment

ID	Title	Description
OG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000

Other Pre-specified

Volume of Distribution at Steady State (Vss) of Temsirolimus

Vss is an estimate of the volume of distribution at steady state. It is used to predict the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.

Posted

Mean

Standard Deviation

Liter

0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment

ID	Title	Description
OG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Palpitations	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Asthenia	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
General physical health deterioration	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Pyrexia	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Anal abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Bronchopneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Cellulitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected76 at risk
Lung infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0016 affected76 at risk
Postoperative wound infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Tonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Blood creatinine increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Tumour embolism	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Spinal cord compression	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Delirium	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Renal failure	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0014 affected76 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Circulatory collapse	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Cataract subcapsular	Eye disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Peritonitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Paraplegia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Completed suicide	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Azotaemia	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Haematuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Renal impairment	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0005 affected6 at risk EG00123 affected76 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0017 affected76 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0018 affected76 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0013 affected76 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0019 affected76 at risk
Palpitations	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected76 at risk
Tachycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0011 affected76 at risk
Ear pain	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Cushing's syndrome	Endocrine disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Blepharitis	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Cataract	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Diabetic retinopathy	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Dry eye	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Eyelid oedema	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Lacrimation increased	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Vision blurred	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Visual impairment	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0019 affected76 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected76 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0018 affected76 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Anal fissure	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected76 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Ascites	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Cheilitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0014 affected76 at risk
Constipation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG00117 affected76 at risk
Dental caries	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected76 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0004 affected6 at risk EG00117 affected76 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Dysphagia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected76 at risk
Gingival pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Gingivitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected76 at risk
Glossitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0019 affected76 at risk
Nausea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG00118 affected76 at risk
Periodontitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0015 affected76 at risk
Proctalgia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Radicular cyst	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Stomatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0005 affected6 at risk EG00142 affected76 at risk
Toothache	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0011 affected76 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG00111 affected76 at risk
Asthenia	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG00110 affected76 at risk
Axillary pain	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Chest discomfort	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected76 at risk
Chest pain	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Chills	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0016 affected76 at risk
Face oedema	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0019 affected76 at risk
Fatigue	General disorders	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG00125 affected76 at risk
Gait disturbance	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
General physical health deterioration	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0012 affected76 at risk
Generalised oedema	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Hypothermia	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Injection site reaction	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Influenza like illness	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0015 affected76 at risk
Localised oedema	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Malaise	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected76 at risk
Mucosal inflammation	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected76 at risk
Non-cardiac chest pain	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected76 at risk
Oedema	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0013 affected76 at risk
Oedema peripheral	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG00113 affected76 at risk
Pyrexia	General disorders	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG00128 affected76 at risk
Thirst	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Drug hypersensitivity	Immune system disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Adenoviral conjunctivitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected76 at risk
Cellulitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected76 at risk
Cystitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Folliculitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected76 at risk
Herpes virus infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Herpes zoster	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Hordeolum	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Oral herpes	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Localised infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Lung infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Nail infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected76 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0018 affected76 at risk
Onychomycosis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Otitis media	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected76 at risk
Paronychia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0017 affected76 at risk
Pharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0015 affected76 at risk
Rash pustular	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Sinusitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected76 at risk
Sputum purulent	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Tooth infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG00120 affected76 at risk
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0011 affected76 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Mouth injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected76 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected76 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Non-systematic Assessment	EG0005 affected6 at risk EG00123 affected76 at risk
Aspartate aminotransferase increased	Investigations	MedDRA	Non-systematic Assessment	EG0005 affected6 at risk EG00123 affected76 at risk
Bacterial test positive	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Blood albumin decreased	Investigations	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG0013 affected76 at risk
Blood alkaline phosphatase	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA	Non-systematic Assessment	EG0004 affected6 at risk EG00112 affected76 at risk
Blood calcium decreased	Investigations	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0013 affected76 at risk
Blood magnesium increased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Blood chloride increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Blood cholesterol increased	Investigations	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG00112 affected76 at risk
Blood creatine increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected76 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Blood creatinine	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected76 at risk
Blood creatinine increased	Investigations	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG00120 affected76 at risk
Blood glucose increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0019 affected76 at risk
Blood iron decreased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Blood lactate dehydrogenase	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Blood lactate dehydrogenase decreased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG00113 affected76 at risk
Blood phosphorus decreased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected76 at risk
Blood potassium decreased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected76 at risk
Blood potassium increased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected76 at risk
Blood pressure increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Blood sodium decreased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected76 at risk
Blood triglycerides increased	Investigations	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG00116 affected76 at risk
Blood urea	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Blood urea increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected76 at risk
C-reactive protein increased	Investigations	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0012 affected76 at risk
Carbon monoxide diffusing capacity decreased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG0017 affected76 at risk
Glycosylated haemoglobin increased	Investigations	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0017 affected76 at risk
Haematocrit decreased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0015 affected76 at risk
Haemoglobin	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Haemoglobin decreased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG00123 affected76 at risk
Lymphocyte count decreased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Neutrophil count decreased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected76 at risk
Neutrophil count increased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected76 at risk
Platelet count decreased	Investigations	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG00118 affected76 at risk
Platelet count increased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0013 affected76 at risk
Protein total decreased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected76 at risk
Protein total increased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0014 affected76 at risk
Prothrombin time prolonged	Investigations	MedDRA	Non-systematic Assessment	EG0004 affected6 at risk EG0010 affected76 at risk
Pulmonary function test abnormal	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Pulmonary function test decreased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Red blood cell count decreased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected76 at risk
Red blood cell count increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Urine output decreased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Weight decreased	Investigations	MedDRA	Non-systematic Assessment	EG0005 affected6 at risk EG00118 affected76 at risk
Weight increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected76 at risk
White blood cell count decreased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG00114 affected76 at risk
White blood cell count increased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0013 affected76 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG00135 affected76 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG0012 affected76 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected76 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG00134 affected76 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG00128 affected76 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0014 affected76 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected76 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0017 affected76 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Hyperphosphatasaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG00131 affected76 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected76 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG00112 affected76 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected76 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0018 affected76 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0018 affected76 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG00128 affected76 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0019 affected76 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG0018 affected76 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0015 affected76 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected76 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected76 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0013 affected76 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG00111 affected76 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Dizziness	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0015 affected76 at risk
Dysgeusia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG0017 affected76 at risk
Headache	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0016 affected76 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG0010 affected76 at risk
Parosmia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Somnolence	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected76 at risk
Tremor	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Anxiety	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Breath holding	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Depressed mood	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Insomnia	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0018 affected76 at risk
Azotaemia	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Incontinence	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Micturition urgency	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Nocturia	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Pollakiuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0013 affected76 at risk
Polyuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Proteinuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected76 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Urinary tract pain	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Menstruation delayed	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected76 at risk
Testicular swelling	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG00119 affected76 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG00116 affected76 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0015 affected76 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG00115 affected76 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0019 affected76 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected76 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG00112 affected76 at risk
Nasal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected76 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG00110 affected76 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0014 affected76 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0017 affected76 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG0010 affected76 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected6 at risk EG0011 affected76 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected76 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0013 affected76 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Blood blister	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected76 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected76 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected76 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected76 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0004 affected6 at risk EG00120 affected76 at risk
Palmar erythema	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0017 affected76 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG00123 affected76 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0006 affected6 at risk EG00143 affected76 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Scar	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Skin erosion	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected76 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0011 affected76 at risk
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected76 at risk
Subcutaneous nodule	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Yellow skin	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Flushing	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Hot flush	Vascular disorders	MedDRA	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected76 at risk
Hypertension	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG00111 affected76 at risk
Phlebitis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected76 at risk
Cardiac valve disease	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Cataract subcapsular	Eye disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Periorbital oedema	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected76 at risk
Breath odour	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Gingival ulceration	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Chest X-ray abnormal	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Hyperchloraemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected76 at risk
Spinal cord compression	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Urine abnormality	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Lower respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected76 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Respiratory gas exchange disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected76 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected76 at risk

ID	Title	Description
BG000	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
BG001	Temsirolimus 25 mg	Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, 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	Temsirolimus 20 mg/m^2	Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.			4	6	6	6
EG001	Temsirolimus 25 mg	Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.			28	76	76	76