Zoledronic Acid in Treating Patients With Metastatic Brea... | NCT00869206

ID	Type	Description	Link
CDR0000637947	Registry Identifier	NCI Physician Data Query
NCI-2009-01102	Registry Identifier	NCI Clinical Trial Reporting Program
U10CA037447	U.S. NIH Grant/Contract		View source

Name	Class
National Cancer Institute (NCI)	NIH

Label	Type	Description	Intervention Names
Arm I (zoledronic acid every 4 weeks)	Experimental	Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.	Drug: zoledronic acid
Arm II (zoledronic acid every 12 weeks)	Experimental	Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.	Drug: zoledronic acid

Name	Type	Description	Arm Group Labels	Other Names
zoledronic acid	Drug	Given IV	Arm I (zoledronic acid every 4 weeks) Arm II (zoledronic acid every 12 weeks)

Measure	Description	Time Frame
Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization	To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone, as measured by the proportion of patients who would have experienced at least one skeletal related event within 24 months after randomization.	2 years

Measure	Description	Time Frame
Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire	To compare pain scores (Brief Pain Inventory) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted for the mean interference score. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. The score of the BPI questionnaire ranges from 0 being no pain to 10 being the most pain. The average score is reported for each arm below.

Name	Affiliation	Role
Andrew L. Himelstein, MD	Helen F. Graham Cancer Center at Christiana Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital		Fairbanks	Alaska	99701	United States

PubMed Identifier	Type	Citation	Retractions
40446745	Derived	Chen F, Zhao B, Tian Y, Liu Q, Zhang B. Metabolic reprogramming on breast cancer stem Cells: Proliferation and self-renewal, epithelial-mesenchymal transition (EMT), and drug resistance. Biochem Biophys Res Commun. 2025 Aug 8;774:152079. doi: 10.1016/j.bbrc.2025.152079. Epub 2025 May 23.
28030702	Derived	Himelstein AL, Foster JC, Khatcheressian JL, Roberts JD, Seisler DK, Novotny PJ, Qin R, Go RS, Grubbs SS, O'Connor T, Velasco MR Jr, Weckstein D, O'Mara A, Loprinzi CL, Shapiro CL. Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial. JAMA. 2017 Jan 3;317(1):48-58. doi: 10.1001/jama.2016.19425.

ID	Title	Description
FG000	Arm I (Zoledronic Acid Every 4 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
FG001	Arm II (Zoledronic Acid Every 12 Weeks)

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization

To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone, as measured by the proportion of patients who would have experienced at least one skeletal related event within 24 months after randomization.

All patients that were eligible and completed treatment were analyzed.

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Arm I (Zoledronic Acid Every 4 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
OG001	Arm II (Zoledronic Acid Every 12 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Units	Counts
Participants	OG000911 OG001911

Title

Denominators

Categories

Title	Measurements
	OG00067.6 OG00167.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		<=.05														Non-Inferiority or Equivalence	Based on the published data on the effect of a standard of dosing schedule of > zoledronic acid compared to placebo, we choose ∆= 7%, πT= 42%, and πS= 35%. With a total of 1230 eligible patients (615 per arm), the probability of rejecting the null hypothesis using a one-sided test is at most 0.05 (Type I error α) when θ≥ 7% and the probability of rejecting the null hypothesis (the power) is at least 82% when θ≤0

Secondary

Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire

To compare pain scores (Brief Pain Inventory) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted for the mean interference score. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. The score of the BPI questionnaire ranges from 0 being no pain to 10 being the most pain. The average score is reported for each arm below.

1766 patients completed treatment and were analyzed.

Posted

Mean

Standard Error

score on a scale

from baseline up to 2 years

ID	Title	Description
OG000	Arm I (Zoledronic Acid Every 4 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
OG001	Arm II (Zoledronic Acid Every 12 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Secondary

Average ECOG Performance Status

To compare functional status (ECOG performance status) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. ECOG performance status is a measurement of a patients disability ranging from 0, fully active and able to carry out all pre disease performance without restriction, to 5, dead. The average performance status is reported below by arm.

1766 patients completed treatment and were analyzed.

Posted

Mean

Standard Error

score on a scale

from baseline up to 2 years

ID	Title	Description
OG000	Arm I (Zoledronic Acid Every 4 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
OG001	Arm II (Zoledronic Acid Every 12 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Secondary

Incidence of Osteonecrosis of the Jaw

To compare the incidence of osteonecrosis of the jaw in patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The percentage of participants with osteonecrosis is reported here.

1766 patients completed treatment and were analyzed.

Posted

Number

percentage of participants

from baseline up to 2 years

ID	Title	Description
OG000	Arm I (Zoledronic Acid Every 4 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
OG001	Arm II (Zoledronic Acid Every 12 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Units	Counts
Participants

Secondary

Incidence of Renal Dysfunction

To compare the incidence of renal dysfunction of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The percentage of patients with renal dysfunction, defined as grade 3 or grade 4 increased creatinine (Common Terminology Criteria for Adverse Events version 3.0), will be reported here.

1689 patients completed treatment and were analyzed.

Posted

Number

percentage of participants

from baseline up to 2 years

ID	Title	Description
OG000	Arm I (Zoledronic Acid Every 4 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
OG001	Arm II (Zoledronic Acid Every 12 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Units	Counts
Participants

Secondary

Skeletal Morbidity Rate

To compare the skeletal morbidity rate, defined as the number of skeletal-related events per year, of patients receiving every 12 week dosing to those receiving every 4 week dosing.

1766 patients were treated and analyzed.

Posted

Mean

Standard Deviation

SRE's per year

from baseline up to 2 years

ID	Title	Description
OG000	Arm I (Zoledronic Acid Every 4 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
OG001	Arm II (Zoledronic Acid Every 12 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Units	Counts
Participants	OG000

Secondary

Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Breast Cancer)

To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The number of patients with high & low CTX values by arm will be reported here.

266 breast cancer patients who were treated and included in this portion of the substudy.

Posted

Count of Participants

Participants

from baseline up to 2 years

ID	Title	Description
OG000	Breast Cancer 4 Weeks	Patients with Breast Cancer receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
OG001	Breast Cancer 12 Weeks	Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Units	Counts
Participants

Secondary

Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Breast Cancer

To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with breast cancer, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.

820 patients completed treatment and were analyzed.

Posted

Count of Participants

Participants

from baseline up to 24 months

ID	Title	Description
OG000	Breast Cancer 4 Weeks	Patients with Breast Cancer receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
OG001	Breast Cancer 12 Weeks	Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Units	Counts
Participants

Secondary

Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Prostate Cancer

To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with prostate cancer, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.

660 patients completed treatment and were analyzed.

Posted

Count of Participants

Participants

from baseline up to 24 months

ID	Title	Description
OG000	Prostate Cancer 4 Weeks	Patients with Prostate Cancer receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
OG001	Prostate Cancer 12 Weeks	Patients with Prostate Cancer receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Units	Counts
Participants

Secondary

Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Multiple Myeloma

To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with multiple myeloma, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.

265 patient completed treatment and were analyzed.

Posted

Count of Participants

Participants

from baseline up to 24 months

ID	Title	Description
OG000	Multiple Myeloma 4 Weeks	Patients with Breast Cancer receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
OG001	Multiple Myeloma 12 Weeks	Patients with Breast Cancer receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Units	Counts
Participants

Secondary

Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Prostate Cancer)

207 prostate cancer patients who were treated and included in this portion of the substudy.

Posted

Count of Participants

Participants

from baseline up to 24 months

ID	Title	Description
OG000	Prostate Cancer 4 Weeks	Patients with Prostate Cancer receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
OG001	Prostate Cancer 12 Weeks	Patients with Prostate Cancer receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Units	Counts
Participants

Secondary

Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Multiple Myeloma)

74 multiple myeloma patients were treated and included in this portion of the substudy.

Posted

Count of Participants

Participants

from baseline up to 24 months

ID	Title	Description
OG000	Multiple Myeloma 4 Weeks	Patients with Breast Cancer receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
OG001	Multiple Myeloma 12 Weeks	Patients with Breast Cancer receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bone marrow hypocellular	Blood and lymphatic system disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0014 events4 affected868 at risk
Hemoglobin decreased	Blood and lymphatic system disorders	MedDRA 12	Systematic Assessment	EG0008 events8 affected879 at risk EG00111 events10 affected868 at risk
Hemolysis	Blood and lymphatic system disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0010 events0 affected868 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events1 affected868 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Cardiac disorder	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0012 events1 affected868 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events1 affected868 at risk
Cardiopulmonary arrest	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Conduction disorder	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Left ventricular failure	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0002 events1 affected879 at risk EG0010 events0 affected868 at risk
Myocardial ischemia	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0010 events0 affected868 at risk
Pericardial effusion	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Restrictive cardiomyopathy	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Right ventricular dysfunction	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events1 affected868 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0013 events2 affected868 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0013 events3 affected868 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0010 events0 affected868 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0013 events3 affected868 at risk
Ascites	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Colitis	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0010 events0 affected868 at risk
Colonic perforation	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Constipation	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0008 events8 affected879 at risk EG00114 events12 affected868 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG00013 events12 affected879 at risk EG00111 events11 affected868 at risk
Duodenal obstruction	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Mucositis oral	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Nausea	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG00013 events13 affected879 at risk EG00117 events16 affected868 at risk
Oral pain	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Proctitis	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0009 events9 affected879 at risk EG00110 events9 affected868 at risk
Chest pain	General disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Death NOS	General disorders	MedDRA 12	Systematic Assessment	EG00014 events14 affected879 at risk EG00114 events14 affected868 at risk
Disease progression	General disorders	MedDRA 12	Systematic Assessment	EG00010 events10 affected879 at risk EG00115 events15 affected868 at risk
Edema limbs	General disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0014 events3 affected868 at risk
Fatigue	General disorders	MedDRA 12	Systematic Assessment	EG0006 events6 affected879 at risk EG00110 events9 affected868 at risk
Fever	General disorders	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0019 events9 affected868 at risk
Flu-like symptoms	General disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
General symptom	General disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0012 events1 affected868 at risk
Multi-organ failure	General disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Pain	General disorders	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0011 events1 affected868 at risk
Biliary fistula	Hepatobiliary disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Gallbladder necrosis	Hepatobiliary disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Bladder infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Bone infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0012 events2 affected868 at risk
Pneumonia	Infections and infestations	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0015 events4 affected868 at risk
Sepsis	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Skin infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Urinary tract infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0012 events2 affected868 at risk
Intraoperative musculoskeletal injury	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Intraoperative neurological injury - Spinal cord	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Alanine aminotransferase increased	Investigations	MedDRA 12	Systematic Assessment	EG0004 events4 affected879 at risk EG0012 events2 affected868 at risk
Alkaline phosphatase increased	Investigations	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0013 events2 affected868 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 12	Systematic Assessment	EG0009 events9 affected879 at risk EG0011 events1 affected868 at risk
Blood bilirubin increased	Investigations	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Cardiac troponin I increased	Investigations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Cardiac troponin T increased	Investigations	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0010 events0 affected868 at risk
Creatine phosphokinase increased	Investigations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Creatinine increased	Investigations	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Electrocardiogram QTc interval prolonged	Investigations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
INR increased	Investigations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Leukocyte count decreased	Investigations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0014 events4 affected868 at risk
Lymphocyte count decreased	Investigations	MedDRA 12	Systematic Assessment	EG0004 events4 affected879 at risk EG0016 events6 affected868 at risk
Neutrophil count decreased	Investigations	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0016 events6 affected868 at risk
Platelet count decreased	Investigations	MedDRA 12	Systematic Assessment	EG0005 events5 affected879 at risk EG0014 events4 affected868 at risk
Weight loss	Investigations	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0012 events2 affected868 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Alkalosis	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Blood glucose increased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0015 events5 affected868 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0004 events4 affected879 at risk EG0016 events4 affected868 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events1 affected868 at risk
Serum albumin decreased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0015 events5 affected868 at risk
Serum calcium decreased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG00032 events28 affected879 at risk EG00139 events34 affected868 at risk
Serum calcium increased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Serum glucose decreased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Serum magnesium increased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0008 events7 affected879 at risk EG00110 events9 affected868 at risk
Serum phosphate decreased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0005 events4 affected879 at risk EG00111 events11 affected868 at risk
Serum potassium decreased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0006 events5 affected879 at risk EG0016 events6 affected868 at risk
Serum potassium increased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0012 events2 affected868 at risk
Serum sodium decreased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG00112 events11 affected868 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0008 events8 affected879 at risk EG0014 events4 affected868 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0005 events5 affected879 at risk EG0013 events3 affected868 at risk
Buttock pain	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0014 events4 affected868 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0004 events4 affected879 at risk EG0014 events4 affected868 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Myelodysplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Treatment related secondary malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Cognitive disturbance	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Dizziness	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Intracranial hemorrhage	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Ischemia cerebrovascular	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0011 events1 affected868 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Syncope	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0012 events2 affected868 at risk
Confusion	Psychiatric disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0015 events4 affected868 at risk
Depression	Psychiatric disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Insomnia	Psychiatric disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0010 events0 affected868 at risk
Renal failure	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Urogenital disorder	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG00030 events23 affected879 at risk EG00122 events18 affected868 at risk
Adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Apnea	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events1 affected868 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0010 events0 affected868 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0013 events3 affected868 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0006 events6 affected879 at risk EG0018 events7 affected868 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0006 events6 affected879 at risk EG0016 events5 affected868 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0012 events2 affected868 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0012 events2 affected868 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0015 events4 affected868 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Hematoma	Vascular disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Hemorrhage	Vascular disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Hypertension	Vascular disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Hypotension	Vascular disorders	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0019 events9 affected868 at risk
Thrombosis	Vascular disorders	MedDRA 12	Systematic Assessment	EG0004 events2 affected879 at risk EG0019 events9 affected868 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood disorder	Blood and lymphatic system disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0012 events2 affected868 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 12	Systematic Assessment	EG00014 events10 affected879 at risk EG0018 events7 affected868 at risk
Hemoglobin decreased	Blood and lymphatic system disorders	MedDRA 12	Systematic Assessment	EG000195 events98 affected879 at risk EG001206 events92 affected868 at risk
Hemolysis	Blood and lymphatic system disorders	MedDRA 12	Systematic Assessment	EG00037 events16 affected879 at risk EG00129 events11 affected868 at risk
Lymphatic disorder	Blood and lymphatic system disorders	MedDRA 12	Systematic Assessment	EG0005 events3 affected879 at risk EG0011 events1 affected868 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA 12	Systematic Assessment	EG0005 events4 affected879 at risk EG0012 events1 affected868 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0009 events9 affected879 at risk EG0012 events2 affected868 at risk
Atrial flutter	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Cardiac disorder	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0014 events4 affected868 at risk
Cardiac pain	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0004 events4 affected879 at risk EG0013 events3 affected868 at risk
Left ventricular failure	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0008 events7 affected879 at risk EG0013 events2 affected868 at risk
Myocardial ischemia	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0007 events7 affected879 at risk EG0012 events1 affected868 at risk
Palpitations	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Pericardial effusion	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Pericarditis	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Restrictive cardiomyopathy	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0012 events2 affected868 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
External ear inflammation	Ear and labyrinth disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
External ear pain	Ear and labyrinth disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA 12	Systematic Assessment	EG0008 events3 affected879 at risk EG0011 events1 affected868 at risk
Middle ear inflammation	Ear and labyrinth disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events1 affected868 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 12	Systematic Assessment	EG0002 events1 affected879 at risk EG0015 events1 affected868 at risk
Cushingoid	Endocrine disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0012 events1 affected868 at risk
Endocrine disorder	Endocrine disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Cataract	Eye disorders	MedDRA 12	Systematic Assessment	EG0005 events4 affected879 at risk EG0013 events3 affected868 at risk
Diplopia	Eye disorders	MedDRA 12	Systematic Assessment	EG0006 events1 affected879 at risk EG0013 events2 affected868 at risk
Dry eye syndrome	Eye disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events1 affected868 at risk
Extraocular muscle paresis	Eye disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Eye disorder	Eye disorders	MedDRA 12	Systematic Assessment	EG0005 events4 affected879 at risk EG00123 events5 affected868 at risk
Optic nerve disorder	Eye disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Retinal detachment	Eye disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Vision blurred	Eye disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0012 events2 affected868 at risk
Vitreous hemorrhage	Eye disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Watering eyes	Eye disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0006 events5 affected879 at risk EG0012 events2 affected868 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG00074 events40 affected879 at risk EG00168 events42 affected868 at risk
Anal exam abnormal	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0002 events1 affected879 at risk EG0010 events0 affected868 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Ascites	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG00015 events7 affected879 at risk EG0012 events1 affected868 at risk
Colitis	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0004 events4 affected879 at risk EG0013 events3 affected868 at risk
Colonic obstruction	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Constipation	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001,527 events348 affected879 at risk EG0011,341 events333 affected868 at risk
Dental prosthesis user	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0005 events2 affected879 at risk EG00110 events2 affected868 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG000693 events276 affected879 at risk EG001754 events275 affected868 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0005 events5 affected879 at risk EG00125 events4 affected868 at risk
Duodenal hemorrhage	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0004 events4 affected879 at risk EG0016 events3 affected868 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG00111 events6 affected868 at risk
Ear, nose and throat examination abnormal	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0004 events4 affected879 at risk EG0014 events2 affected868 at risk
Esophageal hemorrhage	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0002 events1 affected879 at risk EG0010 events0 affected868 at risk
Esophageal mucositis	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Esophageal pain	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0012 events2 affected868 at risk
Esophagitis	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Fecal incontinence	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Flatulence	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Gastric hemorrhage	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0006 events2 affected879 at risk EG0011 events1 affected868 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0004 events3 affected879 at risk EG0010 events0 affected868 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0004 events4 affected879 at risk EG0014 events4 affected868 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0009 events6 affected879 at risk EG0016 events6 affected868 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Ileus	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Mucositis oral	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0016 events5 affected868 at risk
Nausea	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001,187 events367 affected879 at risk EG0011,069 events357 affected868 at risk
Oesophagoscopy abnormal	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Oral pain	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0008 events7 affected879 at risk EG00115 events6 affected868 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Rectal hemorrhage	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Rectal pain	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0013 events3 affected868 at risk
Stomach pain	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0017 events5 affected868 at risk
Tooth development disorder	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Toothache	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0004 events4 affected879 at risk EG00112 events6 affected868 at risk
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12	Systematic Assessment	EG000441 events224 affected879 at risk EG001366 events198 affected868 at risk
Chest pain	General disorders	MedDRA 12	Systematic Assessment	EG00014 events12 affected879 at risk EG00150 events19 affected868 at risk
Chills	General disorders	MedDRA 12	Systematic Assessment	EG0004 events3 affected879 at risk EG0010 events0 affected868 at risk
Edema limbs	General disorders	MedDRA 12	Systematic Assessment	EG00026 events16 affected879 at risk EG00151 events22 affected868 at risk
Facial pain	General disorders	MedDRA 12	Systematic Assessment	EG00011 events4 affected879 at risk EG0010 events0 affected868 at risk
Fatigue	General disorders	MedDRA 12	Systematic Assessment	EG000216 events90 affected879 at risk EG001260 events87 affected868 at risk
Fever	General disorders	MedDRA 12	Systematic Assessment	EG000291 events173 affected879 at risk EG001298 events189 affected868 at risk
Flu-like symptoms	General disorders	MedDRA 12	Systematic Assessment	EG00012 events2 affected879 at risk EG0014 events4 affected868 at risk
Gait abnormal	General disorders	MedDRA 12	Systematic Assessment	EG0004 events4 affected879 at risk EG0011 events1 affected868 at risk
General symptom	General disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Ill-defined disorder	General disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Injection site reaction	General disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Localized edema	General disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Pain	General disorders	MedDRA 12	Systematic Assessment	EG000275 events97 affected879 at risk EG001157 events68 affected868 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0014 events4 affected868 at risk
Gallbladder obstruction	Hepatobiliary disorders	MedDRA 12	Systematic Assessment	EG0003 events2 affected879 at risk EG0010 events0 affected868 at risk
Gallbladder pain	Hepatobiliary disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 12	Systematic Assessment	EG0005 events4 affected879 at risk EG0016 events1 affected868 at risk
Hypersensitivity	Immune system disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Abdominal infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Anal infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Appendicitis perforated	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Bladder infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0012 events2 affected868 at risk
Bone infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0006 events6 affected879 at risk EG0011 events1 affected868 at risk
Bronchitis	Infections and infestations	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0010 events0 affected868 at risk
Catheter related infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG00011 events7 affected879 at risk EG0013 events2 affected868 at risk
Colitis, infectious (e.g., Clostridium difficile)	Infections and infestations	MedDRA 12	Systematic Assessment	EG0002 events1 affected879 at risk EG0013 events1 affected868 at risk
Device related infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0013 events3 affected868 at risk
Endocarditis infective	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Esophageal infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Eye infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Gallbladder infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Gingival infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Ileal infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG00017 events12 affected879 at risk EG00120 events16 affected868 at risk
Joint infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0002 events1 affected879 at risk EG0010 events0 affected868 at risk
Lip infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Lymph gland infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Mucosal infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Nail infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Opportunistic infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0012 events2 affected868 at risk
Peripheral nerve infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0012 events2 affected868 at risk
Pharyngitis	Infections and infestations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Pneumonia	Infections and infestations	MedDRA 12	Systematic Assessment	EG00017 events16 affected879 at risk EG00120 events19 affected868 at risk
Prostate infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Rhinitis infective	Infections and infestations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Sepsis	Infections and infestations	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0013 events3 affected868 at risk
Sinusitis	Infections and infestations	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0011 events1 affected868 at risk
Skin infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG00014 events13 affected879 at risk EG0015 events5 affected868 at risk
Small intestine infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Soft tissue infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Tooth infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0006 events5 affected879 at risk EG0013 events2 affected868 at risk
Upper aerodigestive tract infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Upper respiratory infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Ureteritis	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Urinary tract infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG00022 events19 affected879 at risk EG00114 events13 affected868 at risk
Uterine infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Wound infection	Infections and infestations	MedDRA 12	Systematic Assessment	EG0003 events2 affected879 at risk EG0012 events1 affected868 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Bruising	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0008 events7 affected879 at risk EG00128 events14 affected868 at risk
Gastrointestinal stoma necrosis	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Intraoperative complications	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Intraoperative musculoskeletal injury - Extremity-lower	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Intraoperative neurological injury	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Intraoperative neurological injury - NERVES: Sacral plexus	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events1 affected868 at risk
Prolonged intubation after pulmonary resection (>24 hrs after surgery)	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Radiation recall reaction (dermatologic)	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0013 events2 affected868 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events1 affected868 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0014 events3 affected868 at risk
ADH abnormal	Investigations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0012 events2 affected868 at risk
Alanine aminotransferase increased	Investigations	MedDRA 12	Systematic Assessment	EG00027 events20 affected879 at risk EG00123 events14 affected868 at risk
Alkaline phosphatase increased	Investigations	MedDRA 12	Systematic Assessment	EG00099 events46 affected879 at risk EG00180 events34 affected868 at risk
Amylase increased	Investigations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 12	Systematic Assessment	EG00058 events39 affected879 at risk EG00129 events23 affected868 at risk
Blood bilirubin increased	Investigations	MedDRA 12	Systematic Assessment	EG00017 events15 affected879 at risk EG00118 events12 affected868 at risk
Cardiac troponin I increased	Investigations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Cardiac troponin T increased	Investigations	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0010 events0 affected868 at risk
Coagulopathy	Investigations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Creatine phosphokinase increased	Investigations	MedDRA 12	Systematic Assessment	EG0004 events2 affected879 at risk EG0012 events2 affected868 at risk
Creatinine increased	Investigations	MedDRA 12	Systematic Assessment	EG00023 events14 affected879 at risk EG00110 events10 affected868 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 12	Systematic Assessment	EG0002 events1 affected879 at risk EG0010 events0 affected868 at risk
INR increased	Investigations	MedDRA 12	Systematic Assessment	EG00028 events8 affected879 at risk EG00118 events4 affected868 at risk
Laboratory test abnormal	Investigations	MedDRA 12	Systematic Assessment	EG0006 events4 affected879 at risk EG0010 events0 affected868 at risk
Leukocyte count decreased	Investigations	MedDRA 12	Systematic Assessment	EG000128 events68 affected879 at risk EG001160 events70 affected868 at risk
Lipase increased	Investigations	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0013 events2 affected868 at risk
Lymphocyte count decreased	Investigations	MedDRA 12	Systematic Assessment	EG000126 events41 affected879 at risk EG001143 events45 affected868 at risk
Neutrophil count decreased	Investigations	MedDRA 12	Systematic Assessment	EG000131 events79 affected879 at risk EG001118 events70 affected868 at risk
Platelet count decreased	Investigations	MedDRA 12	Systematic Assessment	EG000108 events53 affected879 at risk EG001138 events59 affected868 at risk
Serum cholesterol increased	Investigations	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Weight gain	Investigations	MedDRA 12	Systematic Assessment	EG00024 events4 affected879 at risk EG00132 events6 affected868 at risk
Weight loss	Investigations	MedDRA 12	Systematic Assessment	EG00027 events11 affected879 at risk EG00130 events14 affected868 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Alkalosis	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG00048 events28 affected879 at risk EG00139 events24 affected868 at risk
Blood bicarbonate decreased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0013 events3 affected868 at risk
Blood glucose increased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG000150 events43 affected879 at risk EG001181 events57 affected868 at risk
Blood uric acid increased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG00023 events20 affected879 at risk EG00122 events22 affected868 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG00129 events2 affected868 at risk
Serum albumin decreased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG00030 events22 affected879 at risk EG00118 events12 affected868 at risk
Serum calcium decreased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG000996 events320 affected879 at risk EG001839 events290 affected868 at risk
Serum calcium increased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG000177 events87 affected879 at risk EG001207 events82 affected868 at risk
Serum glucose decreased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0005 events4 affected879 at risk EG0019 events5 affected868 at risk
Serum magnesium increased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG000101 events56 affected879 at risk EG00193 events61 affected868 at risk
Serum phosphate decreased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG00095 events64 affected879 at risk EG001130 events69 affected868 at risk
Serum potassium decreased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG00041 events30 affected879 at risk EG00145 events26 affected868 at risk
Serum potassium increased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG00013 events11 affected879 at risk EG00112 events11 affected868 at risk
Serum sodium decreased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG00045 events31 affected879 at risk EG00138 events28 affected868 at risk
Serum sodium increased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0012 events2 affected868 at risk
Serum triglycerides increased	Metabolism and nutrition disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG000307 events93 affected879 at risk EG001311 events83 affected868 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG00020 events9 affected879 at risk EG0018 events4 affected868 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG000792 events191 affected879 at risk EG001688 events177 affected868 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG000595 events139 affected879 at risk EG001452 events131 affected868 at risk
Buttock pain	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG00052 events24 affected879 at risk EG00132 events17 affected868 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG00074 events25 affected879 at risk EG00139 events21 affected868 at risk
Fibrosis	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Fibrosis deep connective tissue	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Joint disorder	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Joint range of motion decreased cervical spine	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Joint range of motion decreased lumbar spine	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0014 events1 affected868 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG00027 events22 affected879 at risk EG00122 events19 affected868 at risk
Muscle weakness left-sided	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0013 events3 affected868 at risk
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG00016 events5 affected879 at risk EG0018 events5 affected868 at risk
Muscle weakness right-sided	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Muscle weakness trunk	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events1 affected868 at risk
Muscle weakness upper limb	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0007 events3 affected879 at risk EG0011 events1 affected868 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0007 events4 affected879 at risk EG0013 events3 affected868 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG00073 events46 affected879 at risk EG00179 events44 affected868 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG00058 events29 affected879 at risk EG00179 events38 affected868 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG00020 events15 affected879 at risk EG00110 events5 affected868 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0003 events1 affected879 at risk EG0011 events1 affected868 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG000318 events114 affected879 at risk EG001311 events92 affected868 at risk
Soft tissue necrosis upper limb	Musculoskeletal and connective tissue disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Myelodysplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Treatment related secondary malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12	Systematic Assessment	EG0007 events7 affected879 at risk EG0016 events6 affected868 at risk
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12	Systematic Assessment	EG0004 events4 affected879 at risk EG0014 events3 affected868 at risk
Acoustic nerve disorder NOS	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Arachnoiditis	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0003 events1 affected879 at risk EG0010 events0 affected868 at risk
Ataxia	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0011 events1 affected868 at risk
Cognitive disturbance	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0005 events5 affected879 at risk EG0013 events3 affected868 at risk
Dizziness	Nervous system disorders	MedDRA 12	Systematic Assessment	EG00030 events15 affected879 at risk EG00127 events16 affected868 at risk
Dysgeusia	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0010 events0 affected868 at risk
Encephalopathy	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Extrapyramidal disorder	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Facial muscle weakness	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Facial nerve disorder	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0009 events3 affected879 at risk EG0010 events0 affected868 at risk
Headache	Nervous system disorders	MedDRA 12	Systematic Assessment	EG00058 events29 affected879 at risk EG00163 events37 affected868 at risk
Intracranial hemorrhage	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Ischemia cerebrovascular	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0016 events6 affected868 at risk
Memory impairment	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0004 events2 affected879 at risk EG0011 events1 affected868 at risk
Neuralgia	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0008 events4 affected879 at risk EG0018 events7 affected868 at risk
Neurological disorder NOS	Nervous system disorders	MedDRA 12	Systematic Assessment	EG00010 events7 affected879 at risk EG0013 events3 affected868 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 12	Systematic Assessment	EG00033 events17 affected879 at risk EG00118 events11 affected868 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 12	Systematic Assessment	EG00091 events33 affected879 at risk EG001215 events51 affected868 at risk
Pyramidal tract syndrome	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Radiculitis brachial	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Seizure	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0017 events6 affected868 at risk
Sinus pain	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0002 events1 affected879 at risk EG0012 events2 affected868 at risk
Speech disorder	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Syncope	Nervous system disorders	MedDRA 12	Systematic Assessment	EG00020 events14 affected879 at risk EG00115 events11 affected868 at risk
Syncope vasovagal	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Tremor	Nervous system disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Agitation	Psychiatric disorders	MedDRA 12	Systematic Assessment	EG00010 events1 affected879 at risk EG0010 events0 affected868 at risk
Anxiety	Psychiatric disorders	MedDRA 12	Systematic Assessment	EG0006 events4 affected879 at risk EG0015 events4 affected868 at risk
Confusion	Psychiatric disorders	MedDRA 12	Systematic Assessment	EG00014 events4 affected879 at risk EG0016 events6 affected868 at risk
Depression	Psychiatric disorders	MedDRA 12	Systematic Assessment	EG0006 events4 affected879 at risk EG00125 events12 affected868 at risk
Insomnia	Psychiatric disorders	MedDRA 12	Systematic Assessment	EG00016 events6 affected879 at risk EG00111 events6 affected868 at risk
Libido decreased	Psychiatric disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Psychosis	Psychiatric disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Bladder pain	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Bladder stenosis	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Cystitis	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0011 events1 affected868 at risk
Hemoglobin urine positive	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Hemorrhage urinary tract	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0003 events2 affected879 at risk EG0010 events0 affected868 at risk
Kidney pain	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0014 events4 affected868 at risk
Kidney perforation	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Proteinuria	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Renal failure	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0012 events2 affected868 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Urethral hemorrhage	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk
Urinary frequency	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG00113 events8 affected868 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG00019 events4 affected879 at risk EG0014 events2 affected868 at risk
Urinary retention	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG0006 events4 affected879 at risk EG0014 events4 affected868 at risk
Urogenital disorder	Renal and urinary disorders	MedDRA 12	Systematic Assessment	EG000794 events183 affected879 at risk EG001677 events159 affected868 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 12	Systematic Assessment	EG00042 events7 affected879 at risk EG00116 events10 affected868 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0013 events1 affected868 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 12	Systematic Assessment	EG00031 events14 affected879 at risk EG00112 events9 affected868 at risk
Penile pain	Reproductive system and breast disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0013 events1 affected868 at risk
Prostatic pain	Reproductive system and breast disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Scrotal pain	Reproductive system and breast disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0010 events0 affected868 at risk
Vaginal pain	Reproductive system and breast disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events1 affected868 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0002 events1 affected879 at risk EG0014 events2 affected868 at risk
Apnea	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0005 events1 affected879 at risk EG0010 events0 affected868 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0008 events8 affected879 at risk EG00133 events12 affected868 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG00071 events42 affected879 at risk EG00178 events51 affected868 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0014 events3 affected868 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0008 events7 affected879 at risk EG00114 events14 affected868 at risk
Pharyngeal examination abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0005 events4 affected879 at risk EG0012 events2 affected868 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0008 events7 affected879 at risk EG00130 events13 affected868 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0012 events2 affected868 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0004 events3 affected879 at risk EG0016 events6 affected868 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0012 events2 affected868 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0012 events2 affected868 at risk
Respiratory tract hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Voice alteration	Respiratory, thoracic and mediastinal disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG00011 events4 affected879 at risk EG0018 events4 affected868 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0012 events2 affected868 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events1 affected868 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0002 events1 affected879 at risk EG0014 events4 affected868 at risk
Hand-and-foot syndrome	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG00021 events12 affected879 at risk EG00139 events8 affected868 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0012 events2 affected868 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0012 events1 affected868 at risk
Photosensitivity	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG0016 events3 affected868 at risk
Rash acneiform	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Rash desquamating	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG00013 events7 affected879 at risk EG00119 events7 affected868 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0006 events4 affected879 at risk EG0015 events4 affected868 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0004 events2 affected879 at risk EG0016 events4 affected868 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0003 events2 affected879 at risk EG00113 events1 affected868 at risk
Skin ulceration	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0002 events1 affected879 at risk EG0012 events1 affected868 at risk
Sweating	Skin and subcutaneous tissue disorders	MedDRA 12	Systematic Assessment	EG0003 events3 affected879 at risk EG0012 events2 affected868 at risk
Hematoma	Vascular disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0011 events1 affected868 at risk
Hemorrhage	Vascular disorders	MedDRA 12	Systematic Assessment	EG0000 events0 affected879 at risk EG0012 events2 affected868 at risk
Hot flashes	Vascular disorders	MedDRA 12	Systematic Assessment	EG0002 events2 affected879 at risk EG00132 events9 affected868 at risk
Hypertension	Vascular disorders	MedDRA 12	Systematic Assessment	EG00075 events32 affected879 at risk EG00155 events21 affected868 at risk
Hypotension	Vascular disorders	MedDRA 12	Systematic Assessment	EG0009 events8 affected879 at risk EG00112 events12 affected868 at risk
Peripheral ischemia	Vascular disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0010 events0 affected868 at risk
Thrombosis	Vascular disorders	MedDRA 12	Systematic Assessment	EG00034 events23 affected879 at risk EG00147 events24 affected868 at risk
Vascular disorder	Vascular disorders	MedDRA 12	Systematic Assessment	EG0001 events1 affected879 at risk EG0011 events1 affected868 at risk

ID	Term
D010146	Pain
D001943	Breast Neoplasms
D011471	Prostatic Neoplasms
D009101	Multiple Myeloma

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Arm I (Zoledronic Acid Every 4 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
BG001	Arm II (Zoledronic Acid Every 12 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
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	Arm I (Zoledronic Acid Every 4 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.	41	879	96	879	779	879
EG001	Arm II (Zoledronic Acid Every 12 Weeks)	Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.	42	868	103	868	750	868