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. A. No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms from the Screening Visit to Visit 1.
B. More than 70% compliance with submission of daily ePRO questionnaires in the up to 13 days prior to Visit 1.
C. Among the daily ePRO questionnaires submitted in the up to 13 days prior to Visit 1, at least 70% adherence with taking ETI and as applicable, hypertonic saline and/or dornase alfa, as reported from Screening to Visit 1.
Concomitant Medications. All concomitant medications and concurrent therapies will be documented as noted in the Schedule of Events. Dose, route, unit, frequency of administration, indication for administration and dates of medication will be captured. History of modulator use (ETI and other), hypertonic saline, and dornase alfa use will also be captured.
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. 9.3.1. Excluded Medications
Concomitant Medications. Any medications that the patient is using during the study, including vitamins and/or supplements are considered concomitant medications. New concomitant medications that need to be added to the patient’s regimen during the study should be discussed between the PI and Sponsor before implementing, if possible. If this is not possible, the PI should evaluate the potential medication for interactions, taking into consideration the list of prohibited medications provided in this protocol, before implementing and inform the Sponsor as soon as feasible. If a new concomitant medication is started by another physician that is not associated with the study site without discussion with the PI, the PI should evaluate for interaction potential and inform the Sponsor. Details of all concomitant medication use, including all medications administered for the treatment of AEs, must be recorded in the patient’s case report form (CRF). The use of concomitant medications during the study will be assessed at every visit, as indicated in Table 1. The following are some general guidelines for concomitant medication use based on currently available data: • Concomitant administration of folic acid and/or erythropoiesis-stimulating agents is permitted if on stable doses for at least 4 weeks prior to Baseline. • Concomitant administration of steroids or other immunosuppressants is permitted if the dosage regimen is stable for at least 3 months before enrollment. • Prophylactic antibiotics may be administered if deemed appropriate by local clinical practice and/or guidelines for treatment with a complement inhibitor. Because commercially available products will be used, information about any specific antibiotics administered can be found on the package inserts/product labels for those products. • Gastric acid reducing agents should be avoided whenever possible.
Concomitant Medications. All concomitant medication and concurrent therapies will be documented as noted in the Schedule of Events. Dose, route, unit, frequency of administration, indication for administration and dates of administration will be captured.
Concomitant Medications. All prescription and nonprescription medications taken within 14 days prior to treatment until the long-term follow-up visit will be recorded with start and stop dates captured or indicated as ongoing. All prior IVT anti-VEGF-A therapy administered for central involved DME should also be recorded At each visit following Day 1 participants will be questioned by study staff to assess if they have commenced or had any changes in concomitant medications since the previous visit. Study staff should record all concomitant medications administered to the participant whilst in the clinic.
Concomitant Medications. All subjects enrolled in this study must agree to follow the study protocol with respect to concomitant medications from the Screening Visit through the EOS Visit. The following medications are prohibited from designated timepoints before Day 1 and throughout the study.
a. Systemic corticosteroids (IV/IM/oral): Note: Intranasal corticosteroids, eye drops containing corticosteroids, and inhaled corticosteroids for stable medical conditions are allowed.
b. Intralesional corticosteroids and intra-articular corticosteroids
c. Topical treatments including but not limited to corticosteroids, calcineurin inhibitors, phosphodiesterase inhibitors, retinoids, calcipotriol, capsaicin, camphor, polidocanol or tars
