Study Using CP-751,871 In Patients With Stage IV Colorect... | NCT00560560

Label	Type	Description	Intervention Names
1	Experimental	Single arm study	Biological: CP-751, 871

Name	Type	Description	Arm Group Labels	Other Names
CP-751, 871	Biological	Human IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops.	1

Measure	Description	Time Frame
Estimate of the 6 Month Survival Probability	The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.	Baseline up to Month 6

Measure	Description	Time Frame
Overall Survival	The time from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.	From date of enrollment until death or censorship, up to 33 months
Progression-Free Survival (PFS)

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		San Francisco	California	94115	United States
Pfizer Investigational Site

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

ID	Title	Description
FG000	Figitumumab 20 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.

ID	Title	Description
BG000	Figitumumab 20 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
BG001	Figitumumab 30 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00085 BG00183 BG002168

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

Estimate of the 6 Month Survival Probability

The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.

All enrolled participants.

Posted

Number

95% Confidence Interval

Percent chance of survival

Baseline up to Month 6

ID	Title	Description
OG000	Figitumumab 20 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
OG001	Figitumumab 30 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.

Units	Counts
Participants	OG00085 OG00183

Title

Denominators

Categories

Title	Measurements
	OG00049.4(38.8 to 60.0) OG00144.1(33.4 to 54.9)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The hypotheses for each group were H0:p=0.45 vs H1:p>0.45. There was one interim analysis for futility for each group based on the method of Case and Morgan. The futility boundary was not crossed for 20/kg mg group, but was crossed for the 30/kg mg group. It was recommended to investigators that participants be discontinued from treatment with 30 mg/kg of figitumumab.	Test of probability of 6 month survival	p-Value >0.05 applies to each group (20 mg/kg and 30 mg/kg). Greenwood's formula was used for standard deviation.	>0.05	The final analysis was intended to be a binomial test (death prior to 6 months, yes or no). However, 2 participants in the 30/kg mg group were censored prior to 6 months, so the six month Kaplan and Meier estimates were used for each group instead.					2-Sided

Secondary

Overall Survival

The time from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.

All enrolled participants.

Posted

Median

95% Confidence Interval

Months

From date of enrollment until death or censorship, up to 33 months

ID	Title	Description
OG000	Figitumumab 20 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
OG001	Figitumumab 30 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.

Units	Counts

Secondary

Progression-Free Survival (PFS)

The period from study entry until disease progression. Participants without progression or death were censored at time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of longest diameters of target measurable lesions, or a clear increase in a non-target lesion, or the apprearance of new lesions.

All enrolled participants.

Posted

Median

95% Confidence Interval

months

Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up.

ID	Title	Description
OG000	Figitumumab 20 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
OG001	Figitumumab 30 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.

Secondary

Percentage of Participants With Objective Response

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease. PR applied only to participants with at least one measurable lesion. Greater than or equal to 30 % decrease under baseline of the sum of longest diameters of all target measurable lesions.

Per protocol. All enrolled participants who started treatment, with measurable disease and adequate baseline assessment.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months

ID	Title	Description
OG000	Figitumumab 20 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
OG001	Figitumumab 30 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.

Secondary

Descriptive Summary of Figitumumab Concentration Versus Time

The measurement of mean plasma concentration of figitumumab in Day 1 of Cycle 1,2,3,4,5

All participants for whom PK was assessed at least once. The numbers of participants analyzed are numbers of observation (non-missing concentrations). The numbers for 20 mg/kg group are 84,7,3,2,13 for five cycles, respectively. The numbers for 30 mg/kg group are 79,8,2,2,8 for five cycles, respectively.

Posted

Mean

Standard Deviation

miligrams/liter (mg/L)

Pre-dose on Day 1, 1 hour after end of infusion (post-dose) on Day 2 in Cycle 1, pre-dose on Day 1 in Cycles 2,3,4, 1 hour post-dose on Day 1 in Cycle 5

ID	Title	Description
OG000	Figitumumab 20 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
OG001	Figitumumab 30 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.

Secondary

Participants Reporting Positive for Total Anti-drug Antibodies (ADA)

The immunogenicity of figitumumab in terms of producing an antidrug antibody (ADA) response were monitored.

Participants for whom at least one ADA measurement was done. The outcome was not analyzed and only listing of ADA level for each participant was available.

Posted

Up to 2 hours prior to infusion in Cycles 1 and 4, at the end of treatment, and at the 4th scheduled follow-up visit (~150 days after the last infusion)

ID	Title	Description
OG000	Figitumumab 20 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
OG001	Figitumumab 30 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.

Secondary

Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R)

The quantification of circulating tumor cells (CTCs) expressing the IGF-1R in this patient population. Blood samples were collected, and were measured using an automated microscope system.

All enrolled participants who started treatment and who have at least one sample submitted. The total number of participants for this outcome measure was less than the original population. "N" means the numbers of units analyzed in Pre-treatment and/or Baseline, and Post-Baseline and/or Follow-up, respectively.

Posted

Median

Standard Deviation

number of CTC expressing IGF-1R/ml blood

Cycle 1 pre-dosing and Cycle 4 pre-dosing

ID	Title	Description
OG000	Figitumumab 20 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
OG001	Figitumumab 30 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.

Secondary

Counts of Circulating Tumor Cells (CTCs)

The quantification of circulating tumor cells (CTCs)in this patient population. Blood samples were collected, and were measured using an automated microscope system.

Posted

Median

Standard Deviation

Number of CTC/ml of blood

Cycle 1 pre-dosing and Cycle 4 pre-dosing

ID	Title	Description
OG000	Figitumumab 20 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
OG001	Figitumumab 30 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0011 affected83 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0012 affected83 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected85 at risk EG0014 affected83 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0012 affected83 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0014 affected83 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Deafness bilateral	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Disease progression	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00049 affected85 at risk EG00143 affected83 at risk
Fatigue	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
General physical health deterioration	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0013 affected83 at risk
Malaise	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Oedema peripheral	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Ulcer	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Asthenia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk
Pyrexia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0012 affected83 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Pyelonephritis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0011 affected83 at risk
Abdominal sepsis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Bacteraemia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Escherichia infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Spinal cord injury cauda equina	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0013 affected83 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0013 affected83 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0012 affected83 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Cognitive disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Lethargy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Headache	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Confusional state	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0013 affected83 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0012 affected83 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0012 affected83 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected85 at risk EG0016 affected83 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected85 at risk EG0010 affected83 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0013 affected83 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Palpitations	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Tachycardia	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Deafness	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0012 affected83 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0012 affected83 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Deafness bilateral	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Motion sickness	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00014 affected85 at risk EG00111 affected83 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected85 at risk EG0012 affected83 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected85 at risk EG0017 affected83 at risk
Anal inflammation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00017 affected85 at risk EG0010 affected83 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00015 affected85 at risk EG00125 affected83 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0011 affected83 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0016 affected83 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Flatulence	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0011 affected83 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Gingivitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0011 affected83 at risk
Mucous stools	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00023 affected85 at risk EG00127 affected83 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0013 affected83 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0013 affected83 at risk
Rectal tenesmus	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0013 affected83 at risk
Tongue disorder	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Toothache	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0012 affected83 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00021 affected85 at risk EG00116 affected83 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Gastric atony	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Gastritis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Gingival disorder	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Melaena	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Oral pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Periodontitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Asthenia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00027 affected85 at risk EG00123 affected83 at risk
Chills	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Discomfort	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Disease progression	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00050 affected85 at risk EG00143 affected83 at risk
Extravasation	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Fatigue	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00023 affected85 at risk EG00129 affected83 at risk
Gait disturbance	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
General physical health deterioration	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0017 affected83 at risk
Infusion site erythema	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Injection site reaction	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Malaise	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Mucosal inflammation	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected85 at risk EG0015 affected83 at risk
Oedema	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0010 affected83 at risk
Oedema peripheral	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected85 at risk EG0011 affected83 at risk
Pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0016 affected83 at risk
Pyrexia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected85 at risk EG0013 affected83 at risk
Thirst	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Ulcer	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Catheter site pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Chest pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0013 affected83 at risk
Influenza like illness	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Infusion related reaction	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk
Non-cardiac chest pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk
Performance status decreased	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Suprapubic pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Jaundice	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected85 at risk EG0010 affected83 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0013 affected83 at risk
Seasonal allergy	Immune system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Gingival abscess	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0013 affected83 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0010 affected83 at risk
Onychomycosis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Paronychia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Pyelonephritis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Sinusitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Tooth abscess	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0012 affected83 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG00011 affected85 at risk EG0017 affected83 at risk
Abdominal sepsis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Bacteraemia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Bronchitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Escherichia infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Localised infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Bone fissure	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Contrast media reaction	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Spinal cord injury cauda equina	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Alanine aminotransferase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0014 affected83 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0014 affected83 at risk
Blood albumin decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0005 affected85 at risk EG0015 affected83 at risk
Blood bilirubin increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0013 affected83 at risk
Blood creatine increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Blood creatinine increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0005 affected85 at risk EG0015 affected83 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0009 affected85 at risk EG00111 affected83 at risk
Platelet count decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Transaminases increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Weight decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG00010 affected85 at risk EG00117 affected83 at risk
White blood cell count decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Amino acid level increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Breath sounds abnormal	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
International normalised ratio increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk
Alkalosis	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG00034 affected85 at risk EG00137 affected83 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected85 at risk EG0019 affected83 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG00022 affected85 at risk EG00127 affected83 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0012 affected83 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0012 affected83 at risk
Gout	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected85 at risk EG0013 affected83 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00016 affected85 at risk EG00112 affected83 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected85 at risk EG0017 affected83 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0012 affected83 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected85 at risk EG0013 affected83 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0012 affected83 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected85 at risk EG0011 affected83 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0013 affected83 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Ageusia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Aphonia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Cognitive disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0013 affected83 at risk
Dysgeusia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0013 affected83 at risk
Headache	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected85 at risk EG0018 affected83 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Intention tremor	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Lethargy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00012 affected85 at risk EG0016 affected83 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Presyncope	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Sinus headache	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Neurotoxicity	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Tremor	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Anxiety	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Confusional state	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0017 affected83 at risk
Depressed mood	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Depression	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0014 affected83 at risk
Food aversion	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Insomnia	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected85 at risk EG0014 affected83 at risk
Bladder dilatation	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Choluria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Dysuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0012 affected83 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected85 at risk EG0013 affected83 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Nocturia	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0013 affected83 at risk
Polyuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Renal disorder	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0011 affected83 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected85 at risk EG0012 affected83 at risk
Bladder spasm	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Glycosuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Proteinuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0013 affected83 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Ejaculation disorder	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Oedema genital	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0014 affected83 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected85 at risk EG0017 affected83 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0012 affected83 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected85 at risk EG0016 affected83 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0011 affected83 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected85 at risk EG0012 affected83 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0013 affected83 at risk
Increased viscosity of bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0012 affected83 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0012 affected83 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0013 affected83 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0013 affected83 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0012 affected83 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Macule	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Nail toxicity	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0010 affected83 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected85 at risk EG0015 affected83 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected85 at risk EG0016 affected83 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Hypoaesthesia facial	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Hypertension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected85 at risk EG0016 affected83 at risk
Flushing	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk
Hypotension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Intra-abdominal haematoma	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Superior vena caval occlusion	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Eye disorder	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Eye pain	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0011 affected83 at risk
Periorbital oedema	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected85 at risk EG0010 affected83 at risk
Ocular hyperaemia	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk
Vision blurred	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0011 affected83 at risk
Cushingoid	Endocrine disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected85 at risk EG0012 affected83 at risk

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Figitumumab 20 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.			56	85	85	85
EG001	Figitumumab 30 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.			53	83	83	83