Survival imProvement in Lung cancEr iNduced by DenOsUmab... | NCT02129699

ID	Type	Description
2013-003156-21	EudraCT Number
20080166	Other Grant/Funding Number	AMGEN
SNCTP000000954	Registry Identifier	Swiss National Clinical Trials Portal (SNCTP)

Name	Class
European Organisation for Research and Treatment of Cancer - EORTC	NETWORK
Amgen	INDUSTRY

Label	Type	Description	Intervention Names
None, standard chemotherapy only	Other	4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.	Other: None, standard chemotherapy only
Standard chemotherapy + Denosumab	Experimental	4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.	Drug: Denosumab

Name	Type	Description	Arm Group Labels	Other Names
Denosumab	Drug	Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).

Measure	Description	Time Frame
Overall Survival	OS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last follow-up. OS will be reported for all participants in both treatment arms.	Overall survival was measured from the date of randomization to the date of death, whatever the cause, up to a maximum of 56 months

Measure	Description	Time Frame
Progression-free Survival (PFS) Based on RECIST 1.1	Progression-free survival (PFS) is defined as time from date of randomisation until objective disease progression or death, whichever occurs first. Disease progression and its evaluation are defined based on RECIST 1.1: Progressive disease (PD); > 20% increase in the sum of the longest diameter of target lesions, new lesions or non-equivocal progression in non-target disease. If neither event has been observed, then the patient is censored at the date of the last follow up examination. Patients with new non-lung cancer malignancy must continue to be followed for progression of the original lung cancer. Patients who discontinue treatment prior to documented disease progression, including those who initiate non-protocol therapy prior to progression, will be followed for disease progression and death.

Name	Affiliation	Role
Solange Peters, MD, PhD	Trial Chair, CHUV Lausanne, Switzerland	Study Chair
Mary O'Brien, MD	EORTC Trial Co-Chair, Royal Marden Hospital, Sutton, UK	Study Chair
Sarah Danson, PhD	EORTC Trial Co-Chair, University of Sheffield, Sheffield, UK	Study Chair
Rolf Stahel, MD	Trial Co-Chair, University Hospital of Zuerich, Switzerland	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Univ. Klinik für Innere Medizin V		Innsbruck			Austria
KH der Elisabethinen Linz

PubMed Identifier	Type	Citation	Retractions
15197804	Background	Rosen LS, Gordon D, Tchekmedyian NS, Yanagihara R, Hirsh V, Krzakowski M, Pawlicki M, De Souza P, Zheng M, Urbanowitz G, Reitsma D, Seaman J. Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with nonsmall cell lung carcinoma and other solid tumors: a randomized, Phase III, double-blind, placebo-controlled trial. Cancer. 2004 Jun 15;100(12):2613-21. doi: 10.1002/cncr.20308.
17451841

Label	URL
Sponsor	View source

ID	Title	Description
FG000	None, Standard Chemotherapy Only	4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles): Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 25, 2014	Oct 15, 2021

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

Overall Survival

OS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last follow-up. OS will be reported for all participants in both treatment arms.

Posted

Median

95% Confidence Interval

years

Overall survival was measured from the date of randomization to the date of death, whatever the cause, up to a maximum of 56 months

ID	Title	Description
OG000	None, Standard Chemotherapy Only	4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles): Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
OG001	Standard Chemotherapy + Denosumab	4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).

Units	Counts
Participants	OG000255 OG001259

Title

Denominators

Categories

Title	Measurements
	OG0000.73(0.63 to 0.92) OG0010.68(0.62 to 0.87)

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		Regression, Cox	Cox regression model for treatment effect, analysis adjusted for stratification factors	0.355		Hazard Ratio (HR)	0.96			2-Sided	95	0.78	1.19					Superiority	Pre-specified analysis

Secondary

Progression-free Survival (PFS) Based on RECIST 1.1

Progression-free survival (PFS) is defined as time from date of randomisation until objective disease progression or death, whichever occurs first. Disease progression and its evaluation are defined based on RECIST 1.1: Progressive disease (PD); > 20% increase in the sum of the longest diameter of target lesions, new lesions or non-equivocal progression in non-target disease.

If neither event has been observed, then the patient is censored at the date of the last follow up examination.

Patients with new non-lung cancer malignancy must continue to be followed for progression of the original lung cancer.

Patients who discontinue treatment prior to documented disease progression, including those who initiate non-protocol therapy prior to progression, will be followed for disease progression and death.

Posted

Median

95% Confidence Interval

years

Time from date of randomisation until objective disease progression or death, whichever occurs first, assessed up to a maximum of 56 months

ID	Title	Description
OG000	None, Standard Chemotherapy Only	4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles): Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1

Secondary

Number of Participants With Response (CR+PR) Based on RECIST 1.1

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

For more details to RECIST 1.1 criteria, see https://recist.eortc.org/

Posted

Count of Participants

Participants

Response of the tumour is defined according to RECIST 1.1 criteria, assessed up to 56 months

ID	Title	Description
OG000	None, Standard Chemotherapy Only	4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles): Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
OG001	Standard Chemotherapy + Denosumab	4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).

Secondary

Toxicity Profile of Denosumab

Number of patients with serious adverse events classified according to NCI CTCAE V4.

Posted

Count of Participants

Participants

Assessed up to 56 months

ID	Title	Description
OG000	None, Standard Chemotherapy Only	4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles): Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
OG001	Standard Chemotherapy + Denosumab	4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).

Secondary

Overall Survival by Membranous RANK Expression.

Overall survival is defined as time from the date of randomisation until death from any cause. Patients who are still alive at last contact are censored at the date of last follow up.

Information on RANK(L) measurements was available for 463 patients, 229 in chemotherapy alone and 234 in chemotherapy-denosumab arm, among the total 514 patients randomized in the SPLENDOUR trial.

Posted

Median

95% Confidence Interval

Months

Up to maximum of 56 months

ID	Title	Description
OG000	None, Standard Chemotherapy Only, RANK (+)	Membranous RANK(+) patients only, receiving 4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles): Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
OG001	Standard Chemotherapy + Denosumab, RANK (+)	Membranous RANK(+) patients only, receiving 4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).

Secondary

Overall Survival by Cytoplasmic RANK Expression.

Overall survival is defined as time from the date of randomisation until death from any cause. Patients who are still alive at last contact are censored at the date of last follow up.

Information on RANK(L) measurements was available for 463 patients, 229 in chemotherapy alone and 234 in chemotherapy-denosumab arm, among the total 514 patients randomized in the SPLENDOUR trial.

Posted

Median

95% Confidence Interval

Months

up to a maximum of 56 months

ID	Title	Description
OG000	None, Standard Chemotherapy Only, RANK (+)	Cytoplasmic RANK(+) patients only, receiving 4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles): Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
OG001	Standard Chemotherapy + Denosumab, RANK (+)	Cytoplasmic RANK(+) patients only receiving 4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG00016 events14 affected255 at risk EG00111 events9 affected259 at risk
ANAEMIA OF MALIGNANT DISEASE	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
FEBRILE BONE MARROW APLASIA	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG00111 events10 affected259 at risk
HAEMATOTOXICITY	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk
LEUKOPENIA	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0014 events4 affected259 at risk
NEUTROPENIA	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG00010 events9 affected255 at risk EG0018 events8 affected259 at risk
NORMOCYTIC ANAEMIA	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG0005 events5 affected255 at risk EG00112 events10 affected259 at risk
SPLENIC HAEMORRHAGE	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG00010 events9 affected255 at risk EG00114 events13 affected259 at risk
ATRIAL FIBRILLATION	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
ATRIAL FLUTTER	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CARDIAC ARREST	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CARDIAC FAILURE	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CARDIOGENIC SHOCK	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CARDIOPULMONARY FAILURE	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CORONARY ARTERY INSUFFICIENCY	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0012 events2 affected259 at risk
APLASIA	Congenital, familial and genetic disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
VERTIGO	Ear and labyrinth disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
VERTIGO POSITIONAL	Ear and labyrinth disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0013 events3 affected259 at risk
ANAL HAEMORRHAGE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ASCITES	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
COLITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
CONSTIPATION	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0014 events4 affected259 at risk
DIARRHOEA	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0007 events7 affected255 at risk EG0018 events8 affected259 at risk
DYSPHAGIA	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
ENTEROCOLITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
GASTRITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
GASTROINTESTINAL INFLAMMATION	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
GINGIVAL DISORDER	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ILEUS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
IMMUNE-MEDIATED ENTEROCOLITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
NAUSEA	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0008 events6 affected255 at risk EG00119 events15 affected259 at risk
NEUTROPENIC COLITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ODYNOPHAGIA	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
OESOPHAGEAL STENOSIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
OESOPHAGITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
STOMATITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
VOMITING	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events3 affected255 at risk EG00116 events11 affected259 at risk
ASTHENIA	General disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0013 events3 affected259 at risk
CHEST PAIN	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CONDITION AGGRAVATED	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DEATH	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0015 events5 affected259 at risk
DISEASE PROGRESSION	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
EUTHANASIA	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
FATIGUE	General disorders	CTCAE_v4	Non-systematic Assessment	EG0006 events6 affected255 at risk EG0015 events4 affected259 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	CTCAE_v4	Non-systematic Assessment	EG0005 events5 affected255 at risk EG0017 events6 affected259 at risk
HYPERTHERMIA	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
MALAISE	General disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0010 events0 affected259 at risk
MUCOSAL INFLAMMATION	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PAIN	General disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0017 events7 affected259 at risk
PYREXIA	General disorders	CTCAE_v4	Non-systematic Assessment	EG0005 events5 affected255 at risk EG0012 events2 affected259 at risk
SUDDEN DEATH	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CHOLECYSTITIS	Hepatobiliary disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events2 affected255 at risk EG0010 events0 affected259 at risk
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HYPERSENSITIVITY	Immune system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
APPENDICITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
BACTERIAL SEPSIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
BRONCHITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CELLULITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
DEVICE OCCLUSION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
ENTEROBACTER INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ERYSIPELAS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
FEBRILE INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
FUNGAL INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
GASTROENTERITIS VIRAL	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
HERPES SIMPLEX OESOPHAGITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
INFLUENZA	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0012 events2 affected259 at risk
NECROTISING FASCIITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
NEUTROPENIC SEPSIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
OESOPHAGEAL CANDIDIASIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk
PAROTITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PICORNAVIRUS INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PNEUMONIA	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0009 events9 affected255 at risk EG00117 events17 affected259 at risk
PNEUMONIA NECROTISING	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PNEUMONIA STAPHYLOCOCCAL	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PSEUDOMONAL SEPSIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0009 events9 affected255 at risk EG0014 events4 affected259 at risk
SEPSIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0004 events4 affected255 at risk EG0017 events6 affected259 at risk
SEPTIC SHOCK	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0015 events5 affected259 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
TRACHEOBRONCHITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
URINARY TRACT INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0005 events5 affected255 at risk EG0012 events2 affected259 at risk
UROSEPSIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	CTCAE_v4	Non-systematic Assessment	EG0002 events1 affected255 at risk EG0010 events0 affected259 at risk
TOXICITY TO VARIOUS AGENTS	Injury, poisoning and procedural complications	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
BLOOD CREATININE INCREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
OXYGEN SATURATION DECREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0006 events6 affected255 at risk EG0016 events6 affected259 at risk
DEHYDRATION	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0017 events7 affected259 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0014 events4 affected259 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0012 events2 affected259 at risk
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0013 events3 affected259 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CHONDROCALCINOSIS PYROPHOSPHATE	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
OSTEONECROSIS OF JAW	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
CANCER PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ENDOCRINE NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
LYMPHANGIOSIS CARCINOMATOSA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
METASTASES TO CENTRAL NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RECTAL ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
TUMOUR ASSOCIATED FEVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CAROTID ARTERY OCCLUSION	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CEREBRAL INFARCTION	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CEREBRAL VENOUS SINUS THROMBOSIS	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0013 events1 affected259 at risk
DIZZINESS	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HEADACHE	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
HYPOAESTHESIA	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ISCHAEMIC STROKE	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
NEUROLOGICAL DECOMPENSATION	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PERONEAL NERVE PALSY	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
SYNCOPE	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0013 events3 affected259 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DEVICE BREAKAGE	Product Issues	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
COMPLETED SUICIDE	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CONFUSIONAL STATE	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
DEPRESSION	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
SUICIDE ATTEMPT	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events4 affected255 at risk EG0014 events4 affected259 at risk
CHRONIC KIDNEY DISEASE	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RENAL FAILURE	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0007 events6 affected255 at risk EG0014 events4 affected259 at risk
URINARY RETENTION	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
URINARY TRACT OBSTRUCTION	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0013 events2 affected259 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0013 events3 affected259 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
OESOPHAGOBRONCHIAL FISTULA	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events4 affected255 at risk EG0013 events3 affected259 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0012 events2 affected259 at risk
DRUG ERUPTION	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RASH MACULAR	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
TOXIC EPIDERMAL NECROLYSIS	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
HAEMORRHAGE	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HYPERTENSION	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HYPOTENSION	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
ISCHAEMIA	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANEMIA	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG00117 events13 affected259 at risk
NEUTROPENIA	Blood and lymphatic system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk
ASYSTOLE	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ATRIAL FIBRILLATION	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events4 affected255 at risk EG0017 events6 affected259 at risk
ATRIAL FLUTTER	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0014 events3 affected259 at risk
CARDIAC ARREST	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CARDIAC TOXICITY	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CARDIOGENIC SHOCK	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CHEST PAIN - CARDIAC	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
CIRCULATORY INSUFFICIENCY	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CORONARY INSUFFICIENCY	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
EXTRASYSTOLEN	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HEART FAILURE	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0013 events2 affected259 at risk
MOBITZ (TYPE) II ATRIOVENTRICULAR BLOCK	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected259 at risk
PALPITATIONS	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PERICARDIAL EFFUSION	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
PERICARDIAL TAMPONADE	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PERICARDITIS	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
RIGHT VENTRICULAR DYSFUNCTION	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SINUS BRADYCARDIA	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
SINUS TACHYCARDIA	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0013 events3 affected259 at risk
SUPRAVENTRICULAR EXTRASYSTOLE	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
TACHYCARDIA	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
VALVULAR HEART DEFECT	Cardiac disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
DISORDERS OF EQUILIBRUM	Ear and labyrinth disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
EAR PAIN	Ear and labyrinth disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
EXTERNAL EAR INFLAMMATION	Ear and labyrinth disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HEARING IMPAIRED	Ear and labyrinth disorders	CTCAE_v4	Non-systematic Assessment	EG0006 events6 affected255 at risk EG0013 events3 affected259 at risk
TINNITUS	Ear and labyrinth disorders	CTCAE_v4	Non-systematic Assessment	EG0009 events6 affected255 at risk EG0015 events3 affected259 at risk
VERTIGO	Ear and labyrinth disorders	CTCAE_v4	Non-systematic Assessment	EG0009 events8 affected255 at risk EG00120 events13 affected259 at risk
VESTIBULAR DISORDER	Ear and labyrinth disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ADRENAL INSUFFICIENCY	Endocrine disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CUSHINGOID	Endocrine disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HYPERTHYROIDISM	Endocrine disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HYPOTHYROIDISM	Endocrine disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0013 events3 affected259 at risk
THYROIDITIS	Endocrine disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
BAD VISION RIGHT EYE	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
BLURRED VISION	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0016 events6 affected259 at risk
CONJUCTIVITIS	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CONJUNCTIVITIS	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0008 events7 affected255 at risk EG0019 events6 affected259 at risk
DRY EYE	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events4 affected255 at risk EG0016 events6 affected259 at risk
EXTRAOCULAR MUSCLE PARESIS	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
EYE DISORDER OTHER- HEMORRHAGE EYE	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
EYE IRRITATION	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
EYE PAIN	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0013 events3 affected259 at risk
INFLAMMATION RIGHT EYE	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
INTENSIFIED TEAR FLUID	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
OSCILLOPSIA	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PAPILLEDEMA	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
REDUCED VISION	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SUB CONJUNCTIVAL HEMORRHAGE(LEFT EYE)	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
SUBCONJUNCTIVAL HEMORRHAGE RIGHT EYE	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
VISUAL DISTURBANCES	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
WATERING EYES	Eye disorders	CTCAE_v4	Non-systematic Assessment	EG00011 events8 affected255 at risk EG00110 events7 affected259 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected259 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG00016 events14 affected255 at risk EG00135 events21 affected259 at risk
ANAL ABSCESS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ANAL FISTULA	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
ANAL HEMORRHAGE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
ANAL MUCOSITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ANAL PAIN	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ASCITES	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
BLEEDING SPLEEN	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
BLOATING	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events1 affected259 at risk
CHEILITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
COLITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0013 events3 affected259 at risk
COLONDIVERTICULOSIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
COLONIC OBSTRUCTION	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CONSTIPATION	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG00071 events54 affected255 at risk EG00194 events69 affected259 at risk
CONTIPATION	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
DENTAL CARIES	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
DIARRHEA	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG00057 events41 affected255 at risk EG00174 events53 affected259 at risk
DIGESTION PROBLEMS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
DIVERTICULITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
DIVERTICULOSIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DRY MOUTH	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0015 events5 affected259 at risk
DYSGEUSIA	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events1 affected255 at risk EG0010 events0 affected259 at risk
DYSPEPSIA	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG00010 events7 affected255 at risk EG0018 events7 affected259 at risk
DYSPHAGIA	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG00012 events9 affected255 at risk EG00110 events9 affected259 at risk
ENTEROCOLITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0014 events2 affected259 at risk
EPIGASTRIC DISCOMFORT	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ESOPHAGEAL FISTULA	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
ESOPHAGEAL OBSTRUCTION	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ESOPHAGEAL PAIN	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
ESOPHAGEAL STENOSIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ESOPHAGITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0006 events3 affected255 at risk EG0012 events2 affected259 at risk
FATIGUE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
FLATULENCE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
GASTRIC ULCER	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
GASTRITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0014 events3 affected259 at risk
GASTROESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events4 affected255 at risk EG00110 events9 affected259 at risk
GASTROINTESTINAL BLEEDING	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
GASTROINTESTINAL DISORDERS -OTHER:UMBILICAL HERNIA	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
GASTROINTESTINAL PAIN	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
GINGIVAL PAIN	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HEMORRHOIDAL HEMORRHAGE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
HEMORRHOIDS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0005 events4 affected255 at risk EG0014 events4 affected259 at risk
ILEUS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk
MUCOSITIS ORAL	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG00038 events34 affected255 at risk EG00162 events42 affected259 at risk
NAUSEA	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG000147 events91 affected255 at risk EG001162 events92 affected259 at risk
NEUTROPENIC ENTEROCOLITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ODYNOPHAGIA	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ORAL PAIN	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0014 events4 affected259 at risk
PERIODONTAL DISEASE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0014 events4 affected259 at risk
PERIOTONDAL DISEASE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RECTAL HEMORRHAGE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0010 events0 affected259 at risk
RECTAL MUCOSITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SIGMADIVERTICULITIS	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SORE, SWOLLEN TONGUE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
STOMACH PAIN	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG00010 events10 affected255 at risk EG0012 events2 affected259 at risk
TOOTH EXTRACTION	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
TOOTHACHE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
UPPER GASTROINTESTINAL HEMORRHAGE	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events1 affected259 at risk
VOMITING	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG00061 events45 affected255 at risk EG00167 events45 affected259 at risk
VOMITTING	Gastrointestinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk
PAIN IN EXTREMITY	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ALTERATION OF GENERAL CONDITION	General disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events1 affected255 at risk EG0010 events0 affected259 at risk
ALTERATION OF GENERAL STATUS	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
BACK PAIN	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
BONE PAIN	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CHEST WALL PAIN	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CHILLS	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0016 events5 affected259 at risk
CONSTITUTIONAL SYNDROME	General disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events1 affected255 at risk EG0010 events0 affected259 at risk
CRAMPS	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
DEATH NOS	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DECLINE IN GENERAL HEALTH STATUS	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DECLINE IN HEALTH STATUS	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DECREASED MOBILITY	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DETERIORATION IN HEALTH	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
DETERIORATION OF GENERAL STATE	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DRY MUCOSAE	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
DRY MUCOUS MEMBRANES	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
EDEMA FACE	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
EDEMA LIMBS	General disorders	CTCAE_v4	Non-systematic Assessment	EG00043 events31 affected255 at risk EG00137 events27 affected259 at risk
FACIAL PAIN	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0013 events3 affected259 at risk
FATIGUE	General disorders	CTCAE_v4	Non-systematic Assessment	EG000214 events120 affected255 at risk EG001287 events133 affected259 at risk
FEVER	General disorders	CTCAE_v4	Non-systematic Assessment	EG00023 events22 affected255 at risk EG00130 events21 affected259 at risk
FLU LIKE SYMPTOMS	General disorders	CTCAE_v4	Non-systematic Assessment	EG0009 events7 affected255 at risk EG0016 events5 affected259 at risk
GAIT DISTURBANCE	General disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected259 at risk
GENERAL DETERIORATION	General disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events2 affected255 at risk EG0013 events2 affected259 at risk
GENERAL DISORDERS + ADMINISTRATION SITE CONDITIONS	General disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events1 affected255 at risk EG0011 events1 affected259 at risk
GENERAL HEALTH DETERIORATION	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
GENERALIZED EDEMA	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HEADACHE	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HEALTH DETERIORATION	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
HOT FLASHES DURING THE NIGHT	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
INFUSION SITE EXTRAVASATION	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
INJECTION SITE REACTION	General disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected259 at risk
IRRITABILITY	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
LOCALIZED EDEMA	General disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0016 events5 affected259 at risk
LOSS OF APPETITE	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
MALAISE	General disorders	CTCAE_v4	Non-systematic Assessment	EG00016 events12 affected255 at risk EG00123 events19 affected259 at risk
MULTI-ORGAN FAILURE	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
NIGHT SWEATS	General disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0011 events1 affected259 at risk
NON CARDIAC CHEST PAIN	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events1 affected259 at risk
NON-CARDIAC CHEST PAIN	General disorders	CTCAE_v4	Non-systematic Assessment	EG00018 events15 affected255 at risk EG00124 events21 affected259 at risk
PAIN	General disorders	CTCAE_v4	Non-systematic Assessment	EG00050 events33 affected255 at risk EG00155 events33 affected259 at risk
PAIN IN EXTREMITY	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
PAIN OTHER - LEFT GROIN	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PROGRESSION OF DISEASE	General disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events1 affected255 at risk EG0010 events0 affected259 at risk
SUBFEBRILE TEMPERATURES	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
SUDDEN DEATH NOS	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SWEAT	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SWOLLEN FACE	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
WORSENING OF CLINICAL CONDITION	General disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
WORSENING OF GENERAL CONDITION	General disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
BILE DUCT STENOSIS	Hepatobiliary disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CHOLANGITIS	Hepatobiliary disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CHOLECYSTITIS	Hepatobiliary disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events2 affected255 at risk EG0010 events0 affected259 at risk
HEPATIC PAIN	Hepatobiliary disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
LIVER CONGESTION	Hepatobiliary disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
LIVER LIPOMAS	Hepatobiliary disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
TRANSAMINITIS	Hepatobiliary disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
WORSENING LIVER FUNCTION	Hepatobiliary disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ALLERGIC REACTION	Immune system disorders	CTCAE_v4	Non-systematic Assessment	EG0005 events5 affected255 at risk EG0015 events5 affected259 at risk
INTOLERANCE OF RED BLOOD CELL CONCENTRATE	Immune system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RIGHT CERVICAL LYMPHADENOPATHY	Immune system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
APPENDICITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
BLADDER INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
BRONCHIAL INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG00012 events9 affected255 at risk EG00114 events11 affected259 at risk
CATHETER RELATED INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
ENTEROBACTER CLOACAO INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ENTEROCOLITIS INFECTIOUS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
ESOPHAGEAL INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
FLU LIKE SYMPTOMS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HERPES ZOSTER	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0013 events3 affected259 at risk
INFECTION OF UNCLEAR GENESIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
INFECTIONS & INFESTATIONS OTHER - HEAD COLD	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
INFLUENZA A	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
INFLUENZA B	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
JOINT INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
KIDNEY INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
LARYNGITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
LIP INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0004 events4 affected255 at risk EG0011 events1 affected259 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
LUNG INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG00034 events24 affected255 at risk EG00155 events40 affected259 at risk
MENINGITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
MUCOSAL INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0015 events4 affected259 at risk
MYCOSIS (IN OESOPHAGUS)	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ORAL VIRAL EVENT	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PAPULOPUSTULAR RASH	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PAROTIDITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PENILE INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
PERSISTING INFLAMMATION DUE TO MALIGNANCY	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PHARYNGITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0013 events3 affected259 at risk
PHLEBITIS INFECTIVE	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PLEURAL INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected259 at risk
RASH PUSTULAR	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0013 events3 affected259 at risk
RESPIRATORY INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RHINITIS INFECTIVE	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0012 events2 affected259 at risk
SCROTAL INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SEPSIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG00015 events10 affected255 at risk EG00116 events11 affected259 at risk
SEPTIC SHOCK	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SINUSITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected259 at risk
SKIN INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0004 events3 affected255 at risk EG0019 events7 affected259 at risk
STOMA SITE INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
STOMATITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SUSPECTED INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SUSPECTED INFECTION OF RICKHAM RESERVOIR	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
TOOTH INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events1 affected259 at risk
TRACHEITIS	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
UNCLEAR INFECT-FOCUS, NO GERM-EVIDENCE	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
UPPER RESPIRATORY INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG00022 events18 affected255 at risk EG00133 events24 affected259 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
URETHRAL INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
URINARY TRACT INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0009 events9 affected255 at risk EG00112 events11 affected259 at risk
VIRAL INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
VULVAL INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
WOUND INFECTION	Infections and infestations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ARTIPHICIAL SPHINTER RUPTURE	Injury, poisoning and procedural complications	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DERMATITIS RADIATION	Injury, poisoning and procedural complications	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
FALL	Injury, poisoning and procedural complications	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0013 events3 affected259 at risk
FRACTURE	Injury, poisoning and procedural complications	CTCAE_v4	Non-systematic Assessment	EG0005 events4 affected255 at risk EG0012 events2 affected259 at risk
HIP DISLOCATION	Injury, poisoning and procedural complications	CTCAE_v4	Non-systematic Assessment	EG0003 events1 affected255 at risk EG0010 events0 affected259 at risk
OCCLUSION OF STENT	Injury, poisoning and procedural complications	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
POSTTHORACOTOMY SYNDROM	Injury, poisoning and procedural complications	CTCAE_v4	Non-systematic Assessment	EG0002 events1 affected255 at risk EG0010 events0 affected259 at risk
WOUND COMPLICATION	Injury, poisoning and procedural complications	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
WOUND HAND	Injury, poisoning and procedural complications	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ALKALINE PHOSPHATASE INCREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0005 events3 affected255 at risk EG0010 events0 affected259 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0004 events4 affected255 at risk EG0014 events4 affected259 at risk
C REACTIVE PROTEIN	Investigations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0012 events2 affected259 at risk
CARBON MONOXIDE DIFFUSING CAPACITY DECREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CREATININE INCREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
ELEVATED C REACTIVE PROTEIN VALUES	Investigations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
EOSINOPHIL COUNT INCREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
GGT INCREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0009 events7 affected255 at risk EG0016 events3 affected259 at risk
HYPOMAGNESEMIA	Investigations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
IRON DEFICIENCY	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
LDH INCREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
LEUCOCYTES AND C REACTIVE PROTEIN INCREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
LOSS OF WEIGHT	Investigations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
LOW VITAMIN D	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
LYMPHOCYTE COUNT DECREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0013 events1 affected259 at risk
NEUTROPHIL COUNT DECREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PLATELET COUNT DECREASED	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RAISED CRP	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
URAEMIA	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
WEIGHT LOSS	Investigations	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
WEIGHT GAIN	Investigations	CTCAE_v4	Non-systematic Assessment	EG00056 events34 affected255 at risk EG00197 events50 affected259 at risk
WEIGHT LOSS	Investigations	CTCAE_v4	Non-systematic Assessment	EG00097 events71 affected255 at risk EG001172 events95 affected259 at risk
ANOREXIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG00084 events61 affected255 at risk EG001104 events68 affected259 at risk
APPETITE INCREASED	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CACHEXIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DEHYDRATION	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events3 affected255 at risk EG00111 events9 affected259 at risk
DIABETIC KETOSIS WITH METABOLIC ALKALOSIS	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ELECTROLYTE DEFICIENCY	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
EXSICCOSIS	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
GLUCOSE INTOLERANCE	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
HYPERCHOLESTEROLEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HYPERGLYCEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0006 events5 affected255 at risk EG00119 events5 affected259 at risk
HYPERKALEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events1 affected255 at risk EG0013 events2 affected259 at risk
HYPERURICEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk
HYPOGLYCEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
HYPOKALEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0009 events7 affected255 at risk EG00115 events11 affected259 at risk
HYPOMAGNESEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG00023 events9 affected255 at risk EG00111 events7 affected259 at risk
HYPONATREMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0009 events8 affected255 at risk EG00115 events9 affected259 at risk
HYPOPHOSPHATEMIA	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG00119 events10 affected259 at risk
LOSS OF APPETITE	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PSEUDOGOUT	Metabolism and nutrition disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events1 affected255 at risk EG0010 events0 affected259 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0006 events6 affected255 at risk EG00113 events11 affected259 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG00033 events22 affected255 at risk EG00133 events24 affected259 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG00021 events18 affected255 at risk EG00118 events12 affected259 at risk
CHEST WALL PAIN	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0006 events6 affected255 at risk EG00110 events6 affected259 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events3 affected255 at risk EG0015 events5 affected259 at risk
GENERALIZED MUSCLE WEAKNESS	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0012 events2 affected259 at risk
HERNIATED DISC	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
JOINT EFFUSION	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
LEFT SHOULDER PAIN	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
MUSCLE WEAKNESS LOWER LIMB	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0015 events4 affected259 at risk
MUSCLE WEAKNESS UPPER LIMB	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
MUSCULOSKELETAL PAIN - RIGHT HIP	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0016 events5 affected259 at risk
MYOSITIS	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0014 events4 affected259 at risk
OSTEONECROSIS OF JAW	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0013 events3 affected259 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG00014 events12 affected255 at risk EG00116 events14 affected259 at risk
PAIN LEFT AXILLA	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PAIN OTHER - RIGHT GLUTEAL AREA	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PAIN RIGHT MANDIBULA	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
SHOULDER PAIN	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
TENDONITIS	Musculoskeletal and connective tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ADENOPATHY	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
BRAIN METASTASES	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SEEPING METASTASIS UNDER SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
TENDERNESS AT SITE OF LUNG MASS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
TUMOR PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE_v4	Non-systematic Assessment	EG0008 events6 affected255 at risk EG0017 events7 affected259 at risk
AKATHISIA	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
AMNESIA	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
APHONIA	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0011 events1 affected259 at risk
ATAXIA	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0017 events6 affected259 at risk
CEREBROSPINAL FLUID FISTULA	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
COGNITIVE DISTURBANCE	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CONCENTRATION IMPAIRMENT	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
DIZZINESS	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG00012 events12 affected255 at risk EG00111 events10 affected259 at risk
DYSDIADOCHOKINESIS	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DYSESTHESIA	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected259 at risk
DYSGEUSIA	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG00028 events27 affected255 at risk EG00141 events23 affected259 at risk
DYSPHASIA	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
EXTRAPYRAMIDAL DISORDER	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
FACIAL NERVE DISORDER	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
HEADACHE	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG00019 events15 affected255 at risk EG00120 events19 affected259 at risk
INTRACRANIAL HEMORRHAGE	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0013 events2 affected259 at risk
LETHARGY	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0016 events1 affected259 at risk
MOVEMENTS INVOLUNTARY	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
NEURALGIA	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
NUMBNESS ON THE TIP OF FINGERS	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
OCULOMOTOR NERVE DISORDER	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PARESTHESIA	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG00010 events9 affected255 at risk EG0019 events9 affected259 at risk
PERIPHERAL MOTOR NEUROPATHY	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0005 events3 affected255 at risk EG0017 events3 affected259 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG00011 events11 affected255 at risk EG00118 events14 affected259 at risk
POLYNEUROPATHY	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PRESYNCOPE	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk
RIGHT SIDED SCIATICA	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SEIZURE	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0013 events2 affected259 at risk
SOMNOLENCE	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0013 events3 affected259 at risk
STROKE	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0016 events3 affected259 at risk
SYNCOPE	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0005 events5 affected255 at risk EG0015 events4 affected259 at risk
TRANSIENT ISCHEMIC ATTACKS	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
TREMOR	Nervous system disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected259 at risk
AGITATION	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
ANXIETY	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG00013 events9 affected255 at risk EG00110 events8 affected259 at risk
CONFUSION	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events4 affected255 at risk EG0019 events8 affected259 at risk
DELIRIUM	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DEPRESSION	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG0007 events5 affected255 at risk EG0018 events7 affected259 at risk
HALLUCINATIONS	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk
INSOMNIA	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG00015 events12 affected255 at risk EG00114 events12 affected259 at risk
PSYCHIATRIC DISORDER OTHER: ADAPTIVE DISORDER	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
RESTLESSNESS	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SUICIDE ATTEMPT	Psychiatric disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG00011 events8 affected255 at risk EG0015 events4 affected259 at risk
CHRONIC KIDNEY DISEASE	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0014 events3 affected259 at risk
CYSTITIS	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
CYSTITIS NONINFECTIVE	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
DYSURIA	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
HEMATURIA	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
NYCTURIA	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PROTEINURIA	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RENAL AND URINARY DISORDERS - RENAL PAIN	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
RENAL COLIC	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RENAL FAILURE	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
RENAL INSUFFICIENCY	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events2 affected255 at risk EG0011 events1 affected259 at risk
URINARY FREQUENCY	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
URINARY INCONTINENCE	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
URINARY RETENTION	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected259 at risk
URINARY TRACT INFECTION	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
URINARY TRACT OBSTRUCTION	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events2 affected255 at risk EG0010 events0 affected259 at risk
URINARY TRACT PAIN	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0011 events1 affected259 at risk
URINARY URGENCY	Renal and urinary disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
BREAST PAIN	Reproductive system and breast disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
DYSMENORRHEA	Reproductive system and breast disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ERECTILE DYSFUNCTION	Reproductive system and breast disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
PELVIC PAIN	Reproductive system and breast disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PENILE PAIN	Reproductive system and breast disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk
VAGINAL DRYNESS	Reproductive system and breast disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ADULT RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events1 affected255 at risk EG0010 events0 affected259 at risk
ALLERGIC RHINITIS	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0014 events4 affected259 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0016 events3 affected259 at risk
BRONCHIAL OBSTRUCTION	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
BRONCHIAL STRICTURE	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
BRONCHOPULMONARY HEMORRHAGE	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events1 affected255 at risk EG0010 events0 affected259 at risk
BRONCHOPULMONARY HEMORRHAGE	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0005 events3 affected255 at risk EG00118 events13 affected259 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG00043 events33 affected255 at risk EG00181 events56 affected259 at risk
DYSPNEA	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG00080 events62 affected255 at risk EG001108 events72 affected259 at risk
EMPHYSEMA LUNG	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG00018 events16 affected255 at risk EG00111 events11 affected259 at risk
HEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
HICCUPS	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0015 events5 affected259 at risk
HOARSENESS	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0018 events8 affected259 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0011 events1 affected259 at risk
LARYNGEAL HEMORRHAGE	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0012 events1 affected259 at risk
LARYNGEAL MUCOSITIS	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
LUNG INFECTION	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ORTHOPNEA	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PAIN LARYNX	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PHARYNGEAL MUCOSITIS	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PHARYNGOLARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0006 events6 affected255 at risk EG00114 events11 affected259 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0011 events1 affected259 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0015 events4 affected259 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0005 events5 affected255 at risk EG0011 events1 affected259 at risk
POSTNASAL DRIP	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events4 affected255 at risk EG00110 events8 affected259 at risk
PULMONARY EDEMA	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0012 events2 affected259 at risk
PULMONARY FIBROSIS	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events2 affected255 at risk EG0018 events7 affected259 at risk
RHINITIS SICCA	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
RIGHT BASAL HYPOVENTILATION	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
RIGHT PULMONARY HYPOVENTILATION	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
RUNNING NOSE	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
SINUS DISORDER	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
SNEEZING	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
SORE THROAT	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0014 events4 affected259 at risk
STRIDOR	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
VOICE ALTERATION	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0010 events0 affected259 at risk
WHEEZE	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events1 affected259 at risk
WHEEZING	Respiratory, thoracic and mediastinal disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0015 events4 affected259 at risk
ACTINITIC KERATOSIS	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0006 events6 affected255 at risk EG00110 events9 affected259 at risk
BULLOUS DERMATITIS	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
CELLULITIS	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
DARK SKIN DISCOLORATION AXILLAR, SHOULDER	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events4 affected255 at risk EG0017 events7 affected259 at risk
ECZEMA ARMS AND ABDOMINAL	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
ERYSIPELAS	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events1 affected259 at risk
ERYTHEMA MULTIFORME	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events4 affected255 at risk EG0018 events8 affected259 at risk
EXANTHEMA BOTH ARMS	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
FACIAL WOUND	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
FRAGILITY ON NAILS	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
HAIR WEAKNESS	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events4 affected255 at risk EG0016 events4 affected259 at risk
NAIL DISCOLORATION	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
NAIL RIDGING	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
PERIANAL IRRITATION,WARTS BACK /ONE WART RIGHT EYE	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PERIORBITAL EDEMA	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events2 affected259 at risk
PRURITUS	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG00012 events7 affected255 at risk EG0017 events7 affected259 at risk
PSORIASIS REACTION	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RASH	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
RASH ACNEIFORM	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0006 events6 affected255 at risk EG00110 events10 affected259 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG00010 events8 affected255 at risk EG00117 events14 affected259 at risk
RASH ON ARMS	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SKIN HYPERPIGMENTATION	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
SKIN ULCERATION	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0005 events4 affected255 at risk EG0013 events3 affected259 at risk
TICK BITE	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
TOXIC EPIDERMAL NECROLYSIS	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
URTICARIA	Skin and subcutaneous tissue disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0014 events3 affected259 at risk
PAIN STENT	Surgical and medical procedures	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
PLEURX	Surgical and medical procedures	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
TOOTH EXTRACTION	Surgical and medical procedures	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
ARTERIAL HYPERTENSION	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
HEMATOMA	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0003 events2 affected255 at risk EG0014 events3 affected259 at risk
HOT FLASHES	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0002 events2 affected255 at risk EG0016 events6 affected259 at risk
HOT FLASHES - RIGHT ARM	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HYPERTENSION	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG000218 events96 affected255 at risk EG001326 events109 affected259 at risk
HYPERTENTION	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
HYPOTENSION	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0006 events6 affected255 at risk EG00110 events9 affected259 at risk
LYMPH LEAKAGE	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
LYMPHEDEMA	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0012 events1 affected259 at risk
PERIPHERAL ISCHEMIA	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0005 events2 affected255 at risk EG0010 events0 affected259 at risk
PHLEBITIS	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0004 events3 affected255 at risk EG0012 events2 affected259 at risk
RAYNAUD	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
RAYNAUD'S DISEASE	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
RENAL INFARCTION	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk
THROMBOEMBOLIC EVENT	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG00015 events13 affected255 at risk EG00116 events14 affected259 at risk
VASCULAR DISORDERS - OTHER, SPECIFY	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
VASCULAR SCLEROSIS	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected259 at risk
VASCULITIS	Vascular disorders	CTCAE_v4	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected259 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	None, Standard Chemotherapy Only	4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles): Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
BG001	Standard Chemotherapy + Denosumab	4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
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	None, Standard Chemotherapy Only	4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles): Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1	178	255	97	255	235	255
EG001	Standard Chemotherapy + Denosumab	4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient. Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed. Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).	177	259	138	259	246	259