A Study to Evaluate the Safety and Efficacy of Zoledronic... | NCT00172042

Label	Type	Description	Intervention Names
Zoledronic acid	Experimental	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.	Drug: Zoledronic acid 4 mg
Control	Other	No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.	Drug: Zoledronic acid 4 mg

Name	Type	Description	Arm Group Labels	Other Names
Zoledronic acid 4 mg	Drug	Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).	Control

Measure	Description	Time Frame
Progression-Free Survival	Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.	Up to 24 months
Kaplan-Meier Estimates for Progression-free Survival	Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.	Months 6, 12, 18, and 24
Percentage of Participants With Progression-Free Survival Events	Percentage of Participants with the Progression-free survival events: disease progression and death. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.	Up to 24 months

Measure	Description	Time Frame
Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months	Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Jette			Belgium
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
22730101	Derived	Scagliotti GV, Kosmidis P, de Marinis F, Schreurs AJM, Albert I, Engel-Riedel W, Schallier D, Barbera S, Kuo HP, Sallo V, Perez JR, Manegold C. Zoledronic acid in patients with stage IIIA/B NSCLC: results of a randomized, phase III study. Ann Oncol. 2012 Aug;23(8):2082-2087. doi: 10.1093/annonc/mds128. Epub 2012 Jun 22.

ID	Title	Description
FG000	Zoledronic Acid	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
FG001	Control

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-Free Survival

Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.

Intent-to-Treat Population consisting of all randomized participants.

Posted

Median

95% Confidence Interval

Months

Up to 24 months

ID	Title	Description
OG000	Zoledronic Acid	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
OG001	Control	No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.

Units	Counts
Participants	OG000226 OG001211

Title

Denominators

Categories

Title	Measurements
	OG0009.0(6.8 to 12.4) OG00111.3(7.7 to 15.8)

Secondary

Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months

Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).

Intent-to-Treat Population consisting of all randomized participants.

Posted

Number

Percentage of participants

Months 6, 12, 18 and 24

ID	Title	Description
OG000	Zoledronic Acid	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
OG001	Control	No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.

Units	Counts
Participants

Secondary

Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases

Time to occurrence of bone metastases was defined as the time from randomization to the date of the first documented bone metastases which could be asymptomatic or symptomatic at the time of detection. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).

Intent-to-Treat Population consisting of all randomized participants. Any participant without documented bone metastases at the date of analysis was to be censored at the date of the last bone scan.

Posted

Number

95% Confidence Interval

Percentage of participants

Months 6, 12, 18, and 24

ID	Title	Description
OG000	Zoledronic Acid	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
OG001	Control	No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.

Secondary

Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry

Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event.

Intent-to-Treat Population consisting of all randomized participants.

Posted

Number

Percentage of participants

Months 12 and 24

ID	Title	Description
OG000	Zoledronic Acid	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
OG001	Control	No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.

Units	Counts
Participants	OG000

Secondary

Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE)

Time to the first skeletal related event defined as the time from randomization to the date of occurrence of the first SRE. Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event

Intent-to-Treat Population consisting of all randomized participants. Any participant in whom no SRE had been observed during the study was to be censored at the date of the last visit or the date of death whichever was the earlier.

Posted

Number

95% Confidence Interval

Percentage of participants

Months 6,12, 18, and 24

ID	Title	Description
OG000	Zoledronic Acid	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
OG001	Control	No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.

Units	Counts

Secondary

Kaplan-Meier Estimates for Overall Survival

Intent-to-Treat Population consisting of all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

Months 6, 12, 18, and 24

ID	Title	Description
OG000	Zoledronic Acid	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
OG001	Control	No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.

Units	Counts
Participants	OG000

Primary

Kaplan-Meier Estimates for Progression-free Survival

Intent-to-Treat Population consisting of all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

Months 6, 12, 18, and 24

ID	Title	Description
OG000	Zoledronic Acid	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
OG001	Control	No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.

Units	Counts
Participants

Primary

Percentage of Participants With Progression-Free Survival Events

Percentage of Participants with the Progression-free survival events: disease progression and death. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.

Intent-to-Treat Population consisting of all randomized participants.

Posted

Number

Percentage of participants

Up to 24 months

ID	Title	Description
OG000	Zoledronic Acid	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
OG001	Control	No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0012 affected213 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0012 affected213 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0012 affected213 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected224 at risk EG0010 affected213 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected224 at risk EG0012 affected213 at risk
Atrial flutter	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0013 affected213 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0012 affected213 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected224 at risk EG0012 affected213 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected224 at risk EG0011 affected213 at risk
Sinus tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0012 affected213 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0013 affected213 at risk
Dysphagia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Gastropleural fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Haematemesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Melaena	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected224 at risk EG0011 affected213 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Subileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0012 affected213 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0014 affected213 at risk
Disease progression	General disorders	MedDRA	Systematic Assessment	EG0002 affected224 at risk EG0014 affected213 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0004 affected224 at risk EG0012 affected213 at risk
Influenza like illness	General disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0008 affected224 at risk EG0014 affected213 at risk
Sudden death	General disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Bronchopneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Dental fistula	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Empyema	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Enterocolitis infectious	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Lung abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Lung infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Neutropenic sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected224 at risk EG00110 affected213 at risk
Post procedural infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Pyelonephritis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Septic shock	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0013 affected213 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Electrocardiogram repolarisation abnormality	Investigations	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Lung carcinoma cell type unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0006 affected224 at risk EG00110 affected213 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Metastases to spleen	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Ataxia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Epilepsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0013 affected213 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected224 at risk EG0011 affected213 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Loss of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Speech disorder	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Spinal cord compression	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0012 affected213 at risk
Disorientation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected224 at risk EG0010 affected213 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00012 affected224 at risk EG00110 affected213 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected224 at risk EG0015 affected213 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected224 at risk EG0011 affected213 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 affected224 at risk EG0015 affected213 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected224 at risk EG0011 affected213 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0013 affected213 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Labile blood pressure	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk
Phlebitis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0010 affected213 at risk
Superior vena caval occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected224 at risk EG0011 affected213 at risk
Thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0012 affected213 at risk
Venous thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected224 at risk EG0011 affected213 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00023 affected224 at risk EG00123 affected213 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00012 affected224 at risk EG0017 affected213 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00032 affected224 at risk EG00113 affected213 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00012 affected224 at risk EG00113 affected213 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00024 affected224 at risk EG00123 affected213 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00020 affected224 at risk EG0019 affected213 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG00011 affected224 at risk EG00115 affected213 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG00028 affected224 at risk EG00119 affected213 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG00038 affected224 at risk EG00126 affected213 at risk
Influenza like illness	General disorders	MedDRA	Systematic Assessment	EG00012 affected224 at risk EG0013 affected213 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00046 affected224 at risk EG00122 affected213 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected224 at risk EG00111 affected213 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00017 affected224 at risk EG00119 affected213 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00015 affected224 at risk EG00112 affected213 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected224 at risk EG00116 affected213 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG00011 affected224 at risk EG00112 affected213 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00031 affected224 at risk EG00129 affected213 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 affected224 at risk EG00112 affected213 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00017 affected224 at risk EG00112 affected213 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00017 affected224 at risk EG00114 affected213 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00010 affected224 at risk EG00113 affected213 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00016 affected224 at risk EG00112 affected213 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00011 affected224 at risk EG00111 affected213 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG00015 affected224 at risk EG00113 affected213 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00019 affected224 at risk EG00123 affected213 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG00021 affected224 at risk EG00116 affected213 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00060 affected224 at risk EG00154 affected213 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00046 affected224 at risk EG00149 affected213 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00020 affected224 at risk EG00111 affected213 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00011 affected224 at risk EG00111 affected213 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00017 affected224 at risk EG0016 affected213 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
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	Zoledronic Acid	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
BG001	Control	No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
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	Zoledronic Acid	Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.			71	224	166	224
EG001	Control	No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.			84	213	139	213