Concomitant Medications. Vitamin D and calcium supplements are required to be administered daily from Day 1 (continuing from Protocol BA058-05-003) until the Month 6 Visit. Vitamin D and calcium supplements will be administered in the following doses: 400-800 IU/day (Vitamin D) and 500-100mg/day (calcium), or at a dose to be determined by the Investigator according to the subjects need. The doses and schedule of Vitamin D and calcium supplements, which are part of the study medication protocol, should be adhered to and not be changed other than for medical necessity. The supplements should be taken in the evening with or without food or as otherwise instructed by the Investigator. For any required concomitant medication, such as statins or antihypertensives, the subject must be on a stable dose at study entry and every effort should be made to maintain a stable dose during study participation. The occasional use of over-the-counter medications at approved doses (e.g., ibuprofen or acetaminophen) for headache or minor discomfort is allowed. Occasional short term (<3 months) use of corticosteroids for seasonal allergies or asthma is also allowed. These are to be recorded on the appropriate case report form. Subjects should not take any other medications, including over-the-counter medications, herbal medications, or mega-doses of vitamins during the study without prior approval of the Investigator. If it becomes necessary for a subject to take any other medication during the study, the specific medication(s) and indication(s) must be discussed with the Investigator. All concomitant medications taken during the course of the study must be recorded in the Subject’s medical record or source document and transcribed into the case report form.
Concomitant Medications. Concomitant medication includes prescription and non-prescription drugs or other treatments, and any vaccines other than the study vaccine. Recently used and ongoing medications will be reviewed and recorded during screening. Concomitant medications used by participants post-vaccination will coincide with the collection period of adverse events. All medications taken will be recorded in the eDiary and will be discussed with the participant at the scheduled telephone calls during the study. All medications taken in the first 28 days will be recorded in the eCRF. Thereafter, only the following will be recorded: • All medications taken to treat SAEs • All new vaccinations • All antibiotic use • Any new medication to treat respiratory illness The name of the medication, treatment start and stop dates (or ‘ongoing’), and indication must be recorded on the concomitant medication eCRF. The indication recorded on the concomitant medication eCRF must correspond to a medical term/diagnosis recorded on the adverse event eCRF, or to a pre-existing condition noted in the participant’s medical history, or be noted as prophylaxis, e.g. dietary supplement.
Concomitant Medications. Medications taken by the patient within seven days prior to the first vaccination and throughout the study is recorded on the appropriate case report form. A potential patient is not eligible to enter the study if they are taking any medication that may affect immune function, with the following exceptions: - Patients may take doses of nonprescription strength NSAIDS, acetaminophen, ibuprofen or aspirin for non-chronic headache, muscle pain, trauma or prophylaxis as long as their dosing regimen complies with the recommended dose as found on the product label/package insert. - Patients may receive antihistamine therapy for colds or allergies at low doses. - Patients must continue LHRH agonists, if they were on LHRH agonists at the initiation of the trial. - Patients may take vitamin supplements within a dose range not associated with toxicity. - Patients may take cimetidine or other H(2) blockers. - Patients may receive a maximum of two short courses (not more than 10 days per course) of antibiotics for treatment of minor infection, but not more frequently than twice in a 45 day span. Any other medications that may affect immune function are contraindicated for the duration of the patient's study participation. The same exceptions as above apply during the study.
Concomitant Medications. The investigator or qualified designee will record medications including prescription, over- the-counter (OTC), multivitamins, nutritional and/or herbal supplements, IV medications and fluids, if any, taken by the patient during the trial. All medications related to reportable SAEs and Events of Clinical Interest (ECIs) should be recorded as defined in Section 6.2.
Concomitant Medications. Concomitant medications will be presented in data listings and coded using the WHODRUG dictionary. Concomitant medications will be summarized by treatment group and preferred drug names. Translational Research Assessments Statistical evaluation of translational research assessments will be described in SAP.
Concomitant Medications. 9.3.1. Excluded Medications Patients taking these medications or treatments will be ineligible for enrollment: • Any other investigational drug or device as part of an interventional study; • Intravenous or subcutaneous prostacyclin/prostacyclin analogue; • Intravenous inotropes; • Inhaled nitric oxide (excluding acute vasodilator testing during diagnostic cardiac catheterization); • Prednisone at a dosage > 20 mg/day within 30 days prior to Day 1 or at any time during the study; Patients who take excluded medications during the study should not discontinue study drug solely on this basis. Consultation with the medical monitor should occur prior to study drug discontinuation or withdrawing a patient from the study.
Concomitant Medications. All concomitant medication and concurrent therapies will be documented at Screening and at all Study Visits and at early termination, when applicable. In addition, the use of concomitant inhaled, oral, and IV antibiotics from 30 days prior to Screening through Visit 5 will be documented. Dose, route, unit frequency of administration, and indication for administration and dates of medication will be captured.
Concomitant Medications. Medications taken by the patient within seven days prior to the first vaccination and throughout the study is recorded on the appropriate case report form. A potential patient is not eligible to enter the study if they are taking any medication that may affect immune function, with the following exceptions:
Concomitant Medications. This information appears to be readily available on the Case Report Forms and will be recorded as part of the pre-NDA package.
Concomitant Medications. Concomitant medications recorded on an eCRF that lists the common medications used in this subject population will be summarized. Concomitant medications will be classified using the World Health Organization Drug Dictionary (WHODRL). The frequency of use of selected concomitant medications specified in the study manual including secondary inotropes (dobutamine, milrinone, epinephrine, norepinephrine), pressors, and antiarrhythmics will be summarized. Clinical Laboratory Tests Laboratory data will be summarized by the type of laboratory test. Normal reference ranges and markedly abnormal results (specified in the Statistical Analysis Plan) will be used in the summary of laboratory data. Descriptive statistics will be calculated for each laboratory analyte at baseline and at each scheduled time point.
