Trial Outcomes & Findings for Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients (NCT NCT00262314)

NCT ID: NCT00262314

Last Updated: 2013-11-14

Results Overview

Number of patients experiencing congestive heart failure during the treatment phase of the trial

• Recruitment status: COMPLETED
• Target enrollment: 509 participants
• Primary outcome timeframe: up to 36 months
• Results posted on: 2013-11-14

Participant Flow

Trial Initiation Date: 17 October 2000 (date of first subject first visit). Trial Completion Date 15 July 2008 (date of last subject last visit). 46 centers enrolled at least one subject.

Participant milestones

Measure	Novantrone Therapy Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Overall Study STARTED	509
Overall Study COMPLETED	172
Overall Study NOT COMPLETED	337

Reasons for withdrawal

Measure	Novantrone Therapy Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Overall Study Changing physicians	38
Overall Study Death	12
Overall Study Patient's decision	92
Overall Study Other	95
Overall Study Lost to Follow-up	70
Overall Study Administrative withdrawal	30

Baseline Characteristics

Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients

Baseline characteristics by cohort

Measure	Novantrone Therapy n=509 Participants Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Age, Customized <=18 years	0 participants n=5 Participants
Age, Customized 18 - 70 years	509 participants n=5 Participants
Age Continuous	46 years n=5 Participants
Sex: Female, Male Female	344 Participants n=5 Participants
Sex: Female, Male Male	165 Participants n=5 Participants
Region of Enrollment United States	509 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 36 months

Number of patients experiencing congestive heart failure during the treatment phase of the trial

Outcome measures

Measure	Novantrone Therapy n=509 Participants Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Congestive Heart Failure (Treatment Phase)	6 participants

PRIMARY outcome

Timeframe: up to 5 years

Population: participants with annual follow up data

Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial

Outcome measures

Measure	Novantrone Therapy n=250 Participants Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Congestive Heart Failure (Annual Follow-Up Phase)	4 participants

PRIMARY outcome

Timeframe: up to 36 months

Number of patients with left ventricular ejection fraction test results that decreased below 50% during the treatment phase of the trial

Outcome measures

Measure	Novantrone Therapy n=509 Participants Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Left Ventricular Ejection Fraction (Treatment Phase)	27 participants

PRIMARY outcome

Timeframe: up to 5 years

Population: participants with annual follow up data

Number of patients with left ventricular ejection fraction test results that decreased below 50% during the annual follow-up phase of the trial

Outcome measures

Measure	Novantrone Therapy n=250 Participants Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Left Ventricular Ejection Fraction (Annual Follow-Up Phase)	14 participants

PRIMARY outcome

Timeframe: up to 36 months

Number of serious infections during the treatment phase of the trial

Outcome measures

Measure	Novantrone Therapy n=509 Participants Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Serious Infections (Treatment Phase)	50 number of infections

PRIMARY outcome

Timeframe: up to 5 years

Population: participants with annual follow up data

Number of serious infections during the annual follow-up phase of the trial

Outcome measures

Measure	Novantrone Therapy n=250 Participants Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Serious Infections (Annual Follow-Up Phase)	0 number of infections

PRIMARY outcome

Timeframe: up to 36 months

Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase

Outcome measures

Measure	Novantrone Therapy n=509 Participants Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)	40 participants

PRIMARY outcome

Timeframe: up to 5 years

Population: participants with annual follow up data

Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase

Outcome measures

Measure	Novantrone Therapy n=250 Participants Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)	0 participants

PRIMARY outcome

Timeframe: up to 36 months

Number of infections associated with severe neutropenia at onset during the treatment phase

Outcome measures

Measure	Novantrone Therapy n=509 Participants Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Severe Neutropenia (Treatment Phase)	9 number of infections

PRIMARY outcome

Timeframe: up to 5 years

Population: participants with annual follow up data

Number of infections associated with severe neutropenia at onset during the annual follow-up phase

Outcome measures

Measure	Novantrone Therapy n=250 Participants Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Severe Neutropenia (Annual Follow-Up Phase)	0 number of infections

PRIMARY outcome

Timeframe: up to 36 months

Number of clinical relapses reported during the treatment phase of the trial

Outcome measures

Measure	Novantrone Therapy n=509 Participants Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Clinical Relapses (Treatment Phase)	185 number of relapses

PRIMARY outcome

Timeframe: up to 5 years

Population: participants with annual follow up data

Number of clinical relapses reported during the annual follow-up phase of the trial

Outcome measures

Measure	Novantrone Therapy n=250 Participants Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Clinical Relapses (Annual Follow-Up Phase)	60 number of relapses

PRIMARY outcome

Timeframe: up to 5 years

Outcomes are presented separately above apart from adverse events which are presented in the adverse event section

Outcome measures

Outcome data not reported

Adverse Events

Novantrone Therapy

Serious events: 102 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Novantrone Therapy n=509 participants at risk Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
Infections and infestations Urinary Tract Infection	2.6% 13/509 • Number of events 17 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Pneumonia	0.98% 5/509 • Number of events 8 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Urosepsis	0.79% 4/509 • Number of events 4 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Cellulitis	0.59% 3/509 • Number of events 3 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Sepsis	0.59% 3/509 • Number of events 3 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Lobar Pneumonia	0.39% 2/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Shock Septic	0.39% 2/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Viral Infection	0.39% 2/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Bronchitis Viral	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Cellulitis Gangrenous	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Cystitis	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Fungal Skin Infection	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Herpes Zoster	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Infection	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Localised Infection	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Lung Infection	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Meningitis	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Postoperative Wound Infection	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Pyelonephritis	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Upper Respiratory Tract Infection	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Urinary Tract Infection Enterococcal	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Varicella	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Infections and infestations Wound Sepsis	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Cardiac disorders Cardiomyopathy	0.98% 5/509 • Number of events 5 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Cardiac disorders Myocardial Infarction	0.79% 4/509 • Number of events 4 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Cardiac disorders Cardiac Failure Congestive	0.39% 2/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Cardiac disorders Tachycardia	0.39% 2/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Cardiac disorders Cardio-respiratory Arrest	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Cardiac disorders Mitral Valve Incompetence	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Cardiac disorders Ventricular Hypokinesia	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Investigations Ejection Fraction Decreased	2.8% 14/509 • Number of events 14 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Investigations Methicilin-resistant Staphylococcal Aureus Test Positive	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Injury, poisoning and procedural complications Road Traffic Accident	0.79% 4/509 • Number of events 4 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Injury, poisoning and procedural complications Hip Fracture	0.39% 2/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Injury, poisoning and procedural complications Fibula Fracture	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Injury, poisoning and procedural complications Humerus Fracture	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Injury, poisoning and procedural complications Rib Fracture	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Injury, poisoning and procedural complications Subdural Haematoma	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Injury, poisoning and procedural complications Tendon Rupture	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Injury, poisoning and procedural complications Tibia Fracture	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.6% 8/509 • Number of events 8 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Musculoskeletal and connective tissue disorders Muscular Weakness	0.59% 3/509 • Number of events 3 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Musculoskeletal and connective tissue disorders Osteonecrosis	0.20% 1/509 • Number of events 3 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Musculoskeletal and connective tissue disorders Fasciitis	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Musculoskeletal and connective tissue disorders Osteoarthritis	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Musculoskeletal and connective tissue disorders Periarthritis	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Musculoskeletal and connective tissue disorders Spinal Disorder	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Nervous system disorders Grand Mal Convulsion	0.39% 2/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Nervous system disorders Muscle Spasticity	0.39% 2/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Nervous system disorders Carotid Artery Occlusion	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Nervous system disorders Cerebrovascular Accident	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Nervous system disorders Convulsion	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Nervous system disorders Dizziness	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Nervous system disorders Paraesthesia	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Nervous system disorders Transient Ischemic Attack	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.20% 1/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukemia	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Promyelocytic Leukaemia	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Myeloid Leukemia	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Cancer	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary Tumour	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Vascular disorders Deep Vein Thrombosis	1.2% 6/509 • Number of events 6 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Vascular disorders Hypertension	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Blood and lymphatic system disorders Febrile Neutropenia	0.59% 3/509 • Number of events 3 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Blood and lymphatic system disorders Leukopenia	0.59% 3/509 • Number of events 3 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Gastrointestinal disorders Abdominal Pain	0.20% 1/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Gastrointestinal disorders Nausea	0.39% 2/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Gastrointestinal disorders Vomiting	0.39% 2/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Psychiatric disorders Depression	0.39% 2/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Psychiatric disorders Major Depression	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Psychiatric disorders Mental Status Changes	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Psychiatric disorders Suicidal Ideation	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Surgical and medical procedures Drug Delivery Device Implantation	0.79% 4/509 • Number of events 4 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Surgical and medical procedures Medical Device Implantation	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
General disorders Pyrexia	0.39% 2/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
General disorders Chest Pain	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Renal and urinary disorders Hydronephrosis	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Renal and urinary disorders Nephrolithiasis	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.39% 2/509 • Number of events 2 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Endocrine disorders Hypothyroidism	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Immune system disorders Anaphylactoid Reaction	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Metabolism and nutrition disorders Anorexia	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study
Pregnancy, puerperium and perinatal conditions Abortion Incomplete	0.20% 1/509 • Number of events 1 • Up to 5 years. Combined serious adverse events are displayed for both the Treatment Phase and Annual Follow-Up Phase Only serious adverse events were collected in this study

Other adverse events

Adverse event data not reported

Additional Information

Fernando Dangond, M.D., Medical Responsible

EMD Serono, Inc.

Phone: +1 781 681 2348

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER