Morphotek Investigation in Colorectal Cancer: Research of... | NCT01507545

Label	Type	Description	Intervention Names
MORAb-004	Active Comparator		Drug: MORAb-004 Other: Best supportive care
Placebo	Placebo Comparator		Drug: Placebo Other: Best supportive care

Name	Type	Description	Arm Group Labels	Other Names
MORAb-004	Drug	MORAb-004 8mg per kg IV once a week	MORAb-004
Placebo

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression (PD) or death due to any cause. PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of last tumor assessment without evidence of progression prior to the date of initiation of further antitumor treatment. PFS was summarized for each treatment group using Kaplan-Meier estimation curves.	From the date of randomization to the date of the first observation of PD or death due to any cause (up to approximately 1 year 7 months)

Measure	Description	Time Frame
Overall Survival (OS)	OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause. OS was summarized for each treatment group using Kaplan-Meier estimation curves. In the absence of death confirmation or for participants alive at the time of analysis, the survival time was censored at the last date known to be alive.	From the date of randomization to the date of death due to any cause (up to approximately 1 year 7 months)

Facility	Status	City	State	ZIP	Country	Contacts
Central Hem/Onc Medical Group, Inc.		Alhambra	California	91801	United States
Comprehensive Blood and Cancer Center

ID	Title	Description
FG000	MORAb-004 8.0 mg/kg + BSC	Participants received MORAb-004 8 milligram per kilogram (mg/kg), infusion intravenously (IV), once weekly, in each 2-week treatment cycle along with the best supportive care (BSC) which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).

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

Progression-Free Survival (PFS)

PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression (PD) or death due to any cause. PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of last tumor assessment without evidence of progression prior to the date of initiation of further antitumor treatment. PFS was summarized for each treatment group using Kaplan-Meier estimation curves.

ITT population included all randomized participants, analyzed according to the treatment assigned by the IVRS/IWRS.

Posted

Median

95% Confidence Interval

weeks

From the date of randomization to the date of the first observation of PD or death due to any cause (up to approximately 1 year 7 months)

ID	Title	Description
OG000	MORAb-004 8.0 mg/kg + BSC	Participants received MORAb-004 8 mg/kg, infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
OG001	Placebo + BSC	Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).

Units	Counts
Participants	OG00084 OG00142

Title

Denominators

Categories

Title	Measurements
	OG0008.1(7.9 to 8.1) OG0018.1(8.0 to 8.3)

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		One-sided log-rank test		0.7335		Hazard Ratio (HR)	1.13			2-Sided	95	0.76	1.67					Superiority

Secondary

Overall Survival (OS)

OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause. OS was summarized for each treatment group using Kaplan-Meier estimation curves. In the absence of death confirmation or for participants alive at the time of analysis, the survival time was censored at the last date known to be alive.

ITT population included all randomized participants, analyzed according to the treatment assigned by IVRS/IWRS.

Posted

Median

95% Confidence Interval

months

From the date of randomization to the date of death due to any cause (up to approximately 1 year 7 months)

ID	Title	Description
OG000	MORAb-004 8.0 mg/kg + BSC	Participants received MORAb-004 8 mg/kg, infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
OG001	Placebo + BSC	Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).

Secondary

Overall Response Rate (ORR)

ORR was defined as the percentage of subjects achieving either CR or PR using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

ITT population included all randomized participants, analyzed according to the treatment assigned by IVRS/IWRS.

Posted

Number

95% Confidence Interval

percentage of participants

From the date of randomization to the first documentation of CR or PR (up to approximately 1 year 7 months)

ID	Title	Description
OG000	MORAb-004 8.0 mg/kg + BSC	Participants received MORAb-004 8 mg/kg, infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
OG001	Placebo + BSC	Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).

Secondary

Time to Tumor Response (TTR)

Time to tumor response was defined for those participants with objective evidence of confirmed CR or PR as the time from randomization to first documentation of objective tumor response (CR or PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

ITT population included all randomized participants, analyzed according to the treatment assigned by the IVRS/IWRS.

Here overall number analyzed "N" are the participants who had achieved CR or PR.

Posted

Median

Full Range

weeks

From the date of randomization to first documentation of objective tumor response (CR or PR) (up to approximately 1 year 7 months)

ID	Title	Description
OG000	MORAb-004 8.0 mg/kg + BSC	Participants received MORAb-004 8 mg/kg, infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
OG001	Placebo + BSC	Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).

Secondary

Duration of Response (DOR)

The DOR was defined as the time from first documentation of objective response (CR or PR) to the first documentation of objective tumor progression or death due to any cause. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

ITT population included all randomized participants, analyzed according to the treatment assigned by the IVRS/IWRS. Here overall number analyzed "N" are the participants who had achieved CR or PR.

Posted

Median

Full Range

weeks

From the date of first objective response (CR or PR) to objective tumor progression or death regardless of cause (up to approximately 1 year 7 months)

ID	Title	Description
OG000	MORAb-004 8.0 mg/kg + BSC	Participants received MORAb-004 8 mg/kg, infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
OG001	Placebo + BSC	Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).

Secondary

Biomarkers Based PFS, Within Treatment Group

The statistical evidence to support the use of the biomarker identified in Stage 1 interim analysis for Stage 2 selection of participants as designed was not adequate to clearly define a biomarker responsive population. The study was terminated by the sponsor at the end of Stage 1 and enrollment of stage 2 did not occur due to futility, hence Stage 2 and biomarker based analysis for PFS was not carried out.

The study was terminated by the sponsor at the end of Stage 1 and enrollment of stage 2 did not occur due to futility, hence Stage 2 and biomarker based analysis for PFS was not carried out.

Posted

From the date of randomization up to approximately 1 year 7 months

ID	Title	Description
OG000	MORAb-004 8.0 mg/kg + BSC	Participants received MORAb-004 8 mg/kg, infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
OG001	Placebo + BSC	Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).

Secondary

Biomarkers Based OS, Within Treatment Group

The study was terminated by the sponsor at the end of Stage 1 and enrollment of stage 2 did not occur due to futility, hence Stage 2 and biomarker based analysis for OS was not carried out.

Posted

From the date of randomization up to approximately 1 year 7 months

ID	Title	Description
OG000	MORAb-004 8.0 mg/kg + BSC	Participants received MORAb-004 8 mg/kg, infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
OG001	Placebo + BSC	Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0010 affected40 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0010 affected40 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Caecitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Pyrexia	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0012 affected40 at risk
Asthenia	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Fatigue	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Gait Disturbance	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Hepatic Failure	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0010 affected40 at risk
Abdominal Wall Abscess	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Intestinal Fistula Infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Septic Shock	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Infusion Related Reaction	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected82 at risk EG0012 affected40 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected82 at risk EG0010 affected40 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0010 affected40 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0007 affected82 at risk EG0012 affected40 at risk
Metastases To Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Cauda Equina Syndrome	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Headache	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Presyncope	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Confusional State	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0011 affected40 at risk
Renal Failure	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Urinary Tract Obstruction	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0010 affected40 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0011 affected40 at risk
Embolism	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0010 affected40 at risk
General Physical Health Deterioration	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00010 affected82 at risk EG0015 affected40 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected82 at risk EG0010 affected40 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected82 at risk EG0010 affected40 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Bradycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Palpitations	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Sinus Bradycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Tachycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Sinus Arrhythmia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Eye Pain	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Vision Blurred	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Conjunctivitis	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Eyelid Disorder	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Vitreous Floaters	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00032 affected82 at risk EG00114 affected40 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00022 affected82 at risk EG00113 affected40 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00016 affected82 at risk EG0018 affected40 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00017 affected82 at risk EG0019 affected40 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00016 affected82 at risk EG0016 affected40 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected82 at risk EG0011 affected40 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected82 at risk EG0012 affected40 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected82 at risk EG0012 affected40 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected82 at risk EG0012 affected40 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0010 affected40 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0010 affected40 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0012 affected40 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0010 affected40 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0011 affected40 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0012 affected40 at risk
Colitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Faecal Volume Increased	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Flatulence	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Lip Haematoma	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Paraesthesia Oral	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0012 affected40 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Toothache	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Eructation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Gingival Pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Perianal Erythema	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Fatigue	General disorders	MedDRA 14.1	Systematic Assessment	EG00043 affected82 at risk EG00119 affected40 at risk
Oedema Peripheral	General disorders	MedDRA 14.1	Systematic Assessment	EG00012 affected82 at risk EG0016 affected40 at risk
Pyrexia	General disorders	MedDRA 14.1	Systematic Assessment	EG00011 affected82 at risk EG0015 affected40 at risk
Asthenia	General disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected82 at risk EG0014 affected40 at risk
Chills	General disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected82 at risk EG0014 affected40 at risk
Pain	General disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected82 at risk EG0010 affected40 at risk
Malaise	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected82 at risk EG0010 affected40 at risk
Gait Disturbance	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0010 affected40 at risk
Influenza Like Illness	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0011 affected40 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0010 affected40 at risk
Early Satiety	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Injection Site Reaction	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Chest Discomfort	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Suprapubic Pain	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Jaundice	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0010 affected40 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0012 affected40 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 affected82 at risk EG0018 affected40 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0011 affected40 at risk
Abdominal Infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Bronchitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Cystitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Diarrhoea Infectious	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Oral Candidiasis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0012 affected40 at risk
Oral Herpes	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Infusion Related Reaction	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Compression Fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Blood Alkaline Phosphatase Increased	Investigations	MedDRA 14.1	Systematic Assessment	EG00010 affected82 at risk EG0011 affected40 at risk
Weight Decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG00010 affected82 at risk EG0013 affected40 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0006 affected82 at risk EG0011 affected40 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0005 affected82 at risk EG0010 affected40 at risk
Blood Lactate Dehydrogenase Increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0005 affected82 at risk EG0014 affected40 at risk
Blood Bilirubin Increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0010 affected40 at risk
Blood Creatinine Increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0010 affected40 at risk
Electrocardiogram Abnormal	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0011 affected40 at risk
Activated Partial Thromboplastin Time Prolonged	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0012 affected40 at risk
Blood Cholesterol Increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Blood Magnesium Increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Blood Pressure Decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Blood Uric Acid Increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Cardiac Murmur	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Ejection Fraction Decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
International Normalised Ratio Increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Lymphocyte Count Decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Platelet Count Decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Prothrombin Time Prolonged	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
White Blood Cell Count Decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Blood Glucose Increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Electrocardiogram ST Segment Depression	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Haemoglobin Decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Peritoneal Fluid Analysis Abnormal	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Peritoneal Fluid Analysis Normal	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Transaminases Increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00028 affected82 at risk EG00111 affected40 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected82 at risk EG0013 affected40 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected82 at risk EG0010 affected40 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected82 at risk EG0012 affected40 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0010 affected40 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0011 affected40 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0011 affected40 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0011 affected40 at risk
Failure To Thrive	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Increased Appetite	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00015 affected82 at risk EG0012 affected40 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected82 at risk EG0011 affected40 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected82 at risk EG0012 affected40 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected82 at risk EG0011 affected40 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected82 at risk EG0012 affected40 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected82 at risk EG0012 affected40 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0012 affected40 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0012 affected40 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0012 affected40 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Pain In Jaw	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Musculoskeletal Discomfort	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0012 affected40 at risk
Cancer Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0010 affected40 at risk
Tumour Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Headache	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00016 affected82 at risk EG0018 affected40 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected82 at risk EG0010 affected40 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0013 affected40 at risk
Dysgeusia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0011 affected40 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Paraesthesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0011 affected40 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0010 affected40 at risk
Brain Oedema	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Convulsion	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Hypogeusia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Lethargy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Memory Impairment	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Peroneal Nerve Palsy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Restless Legs Syndrome	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Sinus Headache	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Slow Speech	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Balance Disorder	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Insomnia	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected82 at risk EG0013 affected40 at risk
Anxiety	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected82 at risk EG0012 affected40 at risk
Depression	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0012 affected40 at risk
Libido Decreased	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Proteinuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected82 at risk EG0011 affected40 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Dysuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0010 affected40 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0010 affected40 at risk
Renal Failure	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0012 affected40 at risk
Chromaturia	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Micturition Urgency	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Ureteric Stenosis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Urinary Tract Pain	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Urine Flow Decreased	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Incontinence	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Nephrolithiasis 0	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Pelvic Pain	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Perineal Pain	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Scrotal Swelling	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Scrotal Pain	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00020 affected82 at risk EG0019 affected40 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00012 affected82 at risk EG0019 affected40 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0011 affected40 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0012 affected40 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0011 affected40 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0011 affected40 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0010 affected40 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0010 affected40 at risk
Upper-Airway Cough Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0011 affected40 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Pulmonary Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0011 affected40 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected82 at risk EG0011 affected40 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected82 at risk EG0011 affected40 at risk
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected82 at risk EG0011 affected40 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0014 affected40 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0012 affected40 at risk
Dermatitis Atopic	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Exfoliative Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Pain Of Skin	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Pruritus Generalised	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Rash Erythematous	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected82 at risk EG0011 affected40 at risk
Flushing	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected82 at risk EG0013 affected40 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected82 at risk EG0011 affected40 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 at risk
Hypotension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected82 at risk EG0010 affected40 at risk
Hot Flush	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected82 at risk EG0012 affected40 at risk
Haematoma	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected82 at risk EG0010 affected40 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
BG000	MORAb-004 8.0 mg/kg + BSC	Participants received MORAb-004 8 mg/kg, infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
BG001	Placebo + BSC	Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).
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	MORAb-004 8.0 mg/kg + BSC	Participants received MORAb-004 8 mg/kg, infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).	13	82	31	82	77	82
EG001	Placebo + BSC	Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24).	4	40	15	40	40	40