Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Presence of an active uncontrolled infection.
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
STEP I: Patients must not have active, uncontrolled infection
Patients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient’s ability to participate in the protocol
Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
Patient must not have an active uncontrolled infection
Patients with hepatitis C virus (HCV) infection are eligible provided they meet the other eligibility criteria and:\r\n* They have previously undergone curative therapy and have no evidence of active HCV infection\r\n* They have no evidence of liver damage owing to prior HCV infection
Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Patients with uncontrolled infection
Any active acute or chronic or uncontrolled infection
Patients with active, uncontrolled infection
Subject has an active infection
Active HBV or HCV infection.
Unstable systemic disease or active uncontrolled infection
Active uncontrolled infection;
Patients with a clinically apparent active infection will not be eligible (please note, an isolated elevation in the white blood cell count, by itself, does not constitute evidence of an infection)
Active infection
Patients with uncontrolled infection
No evidence of intercurrent infection
Has an active infection requiring systemic therapy or uncontrolled infection. Has a known additional malignancy that is progressing or requires active treatment. Has an underlying medical condition that would preclude study participation.
Active uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are not excluded
Patients who have an active or uncontrolled infection are not eligible
Patients with an active or uncontrolled infection.
Uncontrolled illness including ongoing or active infection
Active and uncontrolled infection
Active, uncontrolled infection
Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C
Active candida infection, including mucocutaneous infection or history of invasive candidiasis. Additional exclusion criteria for Combination arm PDR001+trametinib
Uncontrolled infection
Have any known active uncontrolled infection
Serious, uncontrolled infection
Research participants with uncontrolled infection
Active infection
Subjects who have an uncontrolled infection are not eligible
Known ongoing or active systemic infection, active hepatitis B or C virus infection
Ongoing or active infection; the requirement for intravenous (IV) antibiotics is considered active infection
Active or uncontrolled infection.
Known active infection requiring parenteral or oral anti-infective treatment, once a patient has completed antibiotics and symptoms of infection have resolved to < grade 2, they are then considered eligible from an infection standpoint
Uncontrolled intercurrent active infection; controlled infection on long term suppressive or maintenance therapy is permissible
Patients with active infection or with a fever > 38.50 C within 3 days of the first scheduled day of dosing;
Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection.
Ongoing active infection; the requirement for intravenous (IV) antibiotics is considered active infection
Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
Active serious infection
Active uncontrolled infection
Uncontrolled Grade 3 or higher infection
Have an active, uncontrolled infection
HBV and HVC co-infection, or HBV and Hep D co-infection
Any active, uncontrolled infection at the time of enrollment
Any serious or uncontrolled medical disorder or active infection
The patient has any ongoing or active infection, including active tuberculosis; Note: a urinary tract infection controlled with oral antibiotics initiated at least 7 days prior to study entry is acceptable
Patients who have an uncontrolled infection are not eligible.
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Active infection not adequately responding to appropriate therapy
Patients who have an uncontrolled infection are not eligible
Any uncontrolled active systemic infection
Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
Patients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient’s ability to participate in the protocol
Any uncontrolled active systemic infection
Active infection within one-week prior to study, including unexplained fever
Presence of a serious acute infection or chronic infection
Patients with evidence of an active bacterial infection or with a fever ? 38.5 ºC (101.3 ºF) within 3 days of the first scheduled day of dosing
Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
Active infection
Active uncontrolled infection.
Any active or uncontrolled infection
Ongoing infection > grade 2
Patient with active or uncontrolled infection
Evidence of active infection
Active uncontrolled infection.
Active infection =< 7 days prior to study entry
Patients with active infection
Uncontrolled active life-threatening infection.
Patients with active infection will not be eligible, but may become eligible once infection has resolved and they are at least 7 days from completion of antibiotics
Recent (< 4 weeks) active, documented, cervical infection
Patients with active infection
Infection: Patients who have an uncontrolled infection are not eligible
Evidence of severe of uncontrolled infection.
No evidence of active, uncontrolled infection
Patients should not have any evidence of active or uncontrolled infection requiring treatment with antibiotics
Active infection of any kind.
Significant co-morbid illness such as uncontrolled diabetes or active infection that would preclude treatment on this regimen
Presence of active untreated infection
Active and uncontrolled infection at time of transplantation.
Patients that have an active, uncontrolled infection are not eligible
Active and uncontrolled disease/infection as judged by the treating physician
No active or uncontrollable infection.
Active infection
Patients should not have any uncontrolled illness including ongoing or active or poorly controlled infection
Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis).
Active uncontrolled infection
Active and uncontrolled disease/infection as judged by the treating physician
Patients should not have any uncontrolled illness including ongoing or active infection
Active and uncontrolled infection at time of transplantation.
Active uncontrolled infection
Uncontrolled ongoing infection.
Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
Active and uncontrolled disease (active infection requiring systemic therapy, fever likely secondary to infection within prior 48 hours, uncontrolled hypertension despite adequate medical therapy as judged by the treating physician.
Research participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
Ongoing or active infection
Patients who have an uncontrolled infection are not eligible
Recent or ongoing serious infection, including:
Active infection or corneal ulcer (e.g. keratitis)
Uncontrolled active infection or uncontrolled invasive fungal infection (positive blood or tissue culture). An infection controlled with an approved or closely monitored antibiotic/antifungal treatment is allowed
Patients who have an uncontrolled infection are not eligible
Serious concurrent illness, including clinically relevant active infection
Patients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have known hepatitis C, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
Active life-threatening infection
Patients with uncontrolled infection are excluded
Known untreated or uncontrolled acute infection, including urinary tract infection, within 7 days of study entry
Uncontrolled infection
Active uncontrolled infection;
Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
Active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection)
Have uncontrolled intercurrent illness including, but not limited to, an ongoing/active infection requiring parenteral antibiotics.
Active infection at the site to be irradiated
Within 14 days before first dose of protocol-indicated treatment:\r\n* Active uncontrolled infection; patients with infection under active treatment and controlled with antibiotics initiated at least 14 days prior to initiation of protocol-indicated treatment are not excluded (e.g. urinary tract infection controlled with antibiotics)
Subject has an untreated or uncontrolled infection defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment.
Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection
Uncontrolled serious infection at the time of enrollment; infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, patients do not have signs of infection progression; progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection
Patient has an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive study treatment or undergo study procedures
Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever > 38.5 degrees Celsius (C) that has not been evaluated for infection up to the day of initial dosing; patients with documented history of tumor fever are accepted provided acute or chronic infection has been excluded as possible cause of the fever
Uncontrolled, serious active infection at screening
Active, uncontrolled infection.
Active life-threatening infection
Active infection at screening or history of severe infection within the previous 3 months, if clinically relevant at screening as considered by the investigator
Active uncontrolled infection or severe systemic infection (enrollment is possible after control of infection).
Active infection causing fever.
Any uncontrolled infection
Presence of an serious illness, uncontrolled illness, or active infection requiring IV antibiotics.
Patients must be free of uncontrolled infection
Untreated active infection
Active infection, including any active viral infection, =< 5 days prior to registration
Active and uncontrolled disease/infection as judged by the treating physician
Clinically active infection (>= grade 2) as judged by the site investigator
Has an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the subject to receive protocol treatment.
Active, uncontrolled infection
Any uncontrolled active systemic infection
Active life-threatening infection
Be presenting with recurrent CMV infection (defined as a new detection of CMV infection in a subject who had at least one previously documented episode of CMV infection posttransplant, and who has had at least 2 weeks of undetectable CMV DNA between the episodes (during active surveillance, based on same local laboratory and same sample type). The subject must also have been off any anti-CMV treatment between the current and prior infection. Otherwise, the current infection may be considered continuation of the prior infection.
Active infection
Patients who have an uncontrolled infection
Active infection or corneal ulcer
Ongoing or active infection;
Uncontrolled infection
Patients should not have any uncontrolled illness including ongoing or active infection
Patients should not have any uncontrolled illness including ongoing or active infection
Active uncontrolled infection
Recent culture-documented infection requiring intravenous antimicrobials that was completed =< 7 days before the first dose of study drug or any uncontrolled active systemic infection; fever of unknown origin is not an exclusion criterion, as this may be disease-related
Untreated active infection
Active infection
Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
Patients with active infection will not be eligible, but may become eligible once infection has resolved and at least 7 days have relapsed after antibiotics use was completed
Any uncontrolled active systemic infection
Uncontrolled active, untreated, or progressive infection
Ongoing or active systemic infection or active hepatitis B or C virus infection
Patients should not have any uncontrolled illnesses including ongoing or active infection
No active or uncontrollable infection
Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
Any uncontrolled active systemic infection
Patients who have an uncontrolled infection are not eligible
Active, uncontrolled infection; patients with infection controlled with antibiotics are eligible
HIV infection, active Hepatitis B or C infection, or active infections requiring oral or intravenous antibiotics or that can cause a severe disease and pose a severe danger to lab personnel working on patients' blood or tissue. If positive test results are not indicative of an active infection, patients can be included.
Active uncontrolled serious infection
Has any serious or uncontrolled active infection
Uncontrolled disease/infection as judged by the treating physician
Have any active and uncontrolled infection
Active infection
Patients with active, uncontrolled infection
Uncontrolled active, untreated, or progressive infection
Patients who have an uncontrolled serious infection are NOT eligible for either Stratum
Patients should not have any uncontrolled illness including ongoing or active infection
Active infection not adequately responding to appropriate therapy
Untreated active infection
Persistent fever (>24 hours) documented by repeated measurement or active, uncontrolled infection within 4 weeks of enrollment.
Has an uncontrolled, life-threatening active infection
Uncontrolled infection
Active infection =< 5 days prior to registration
No clinical evidence of life-threatening infection
Untreated active infection
Patients with untreated or uncontrolled life-threatening infection
Active life-threatening infection
Patients must not have untreated or uncontrolled life-threatening infection
Uncontrolled active infection
Current evidence of fever or untreated infection
Serious (i.e., >= grade 3) uncontrolled infection
No uncontrolled infection
Subjects with an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis A, B or C infection
Patients with active infection
Subjects must not have any active and uncontrolled infection
Presence of serious infection
Uncontrolled active infection
Patients who have an uncontrolled infection are not eligible
Patients with recent (within 14 days) or serious ongoing infection
Presence of an active, uncontrolled infection
Subjects with active infection that requires parenteral antibiotics
Active infection
Active life-threatening infection
Evidence of ongoing, uncontrolled infection
Serious (ie, >= grade 3) uncontrolled infection
Active clinically serious and uncontrolled infection > CTCAE grade 2 uncontrolled with antibiotics
Active and uncontrolled disease/infection as judged by the treating physician
Subject has a chronic or acute hepatitis C infection; subject with an old infection that has cleared may be included
Subject has a chronic or acute hepatitis B infection; subject with an old infection that has cleared may be included
Patients who have an uncontrolled infection are not eligible
Active infection not responding to appropriate therapy as determined by study chair
Uncontrolled infection
Active, uncontrolled infection
Subjects who have an uncontrolled infection are not eligible
Presence of any untreated systemic infection
Active infection that is not responding to antimicrobial therapy
Patients who have an uncontrolled infection are not eligible.
Patients should not have any uncontrolled illness including ongoing or active infection requiring therapy
No evidence of ongoing, uncontrolled infection
Evidence of ongoing, uncontrolled infection
Current infection
Uncontrolled infections; patients still under therapy for presumed or proven infection are eligible provided there is clear evidence (radiologic, clinical and/or culture) that the infection is well controlled
Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection.
Presence of active or chronic infection
Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study
TREATMENT: Patients with severe active infection
Evidence of untreated infection
Active clinically serious and uncontrolled infection
No evidence of active infection and no serious infection within the past month
Evidence of active infection, or serious infection within the past month
Research participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
Active and uncontrolled disease/infection as judged by the treating physician
No evidence of active infection and no serious infection within the past month
Evidence of active infection, or serious infection within the past month
Uncontrolled intercurrent illness including active infection
Active uncontrolled infection
Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
Active herpes zoster infection
Uncontrolled infection
Active life-threatening infection
Uncontrolled illness including ongoing or active infection
Active uncontrolled infection
Active infection =< 5 days prior to registration
Patients with an active infection or with a fever ? 38.5°C within 3 days of the first scheduled day of dosing.
Uncontrolled active infection
Active infection or unexplained fever
Uncontrolled infection
Patients with active infection
No active infection
Evidence of active infection or serious infection within the past month
Uncontrolled active infection
RECIPIENT: Active infection refractory to antimicrobial therapy
No evidence of active infection and no serious infection within the past month
Evidence of active infection, or serious infection within the past month
Active life-threatening infection
Active infection
Active or uncontrolled infection
Patients who have an uncontrolled infection
Presence of uncontrolled infection
Uncontrolled intercurrent illness including, but not limited to, active infection requiring hospitalization
Unexplained fever and/or untreated, active infection
Patients with active, uncontrolled infection are not eligible for this study
Active life-threatening infection
Ongoing or active infection
Have an active, uncontrolled infection
Any uncontrolled active systemic infection
Active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or human immunodeficiency virus (HIV) infection
Patients with uncontrolled infection
Patients who have evidence of active infection that requires antibiotic therapy; patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection; if patient develops an infection requiring antibiotic treatment while on the treatment portion of the study patients will be treated for the active infection with antibiotics and will resume vaccine treatment when the infection is healed
Active uncontrolled infection.
Active infection that is not responding to antimicrobial therapy
Presence of active untreated infection
Evidence of active acute or chronic infection
Active life-threatening infection
Uncontrolled active infection
Active and uncontrolled infection at time of transplantation
Active, uncontrolled infection (e.g. Hepatitis A, B, or C)
Active uncontrolled infection
Active uncontrolled infection
Active uncontrolled infection
Presence of active infection
Active infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days)
Active infection at time of transplantation (including active infection with aspergillus or other mold within 30 days)
Current active serious infection
Patients with an uncontrolled life-threatening infection
Serious concurrent illness, including clinically relevant active infection
Active uncontrolled infection
Treated with antibiotics for infection within one week prior to study entry.
Persistent fever (>24 hours) documented by repeated measurement or active, uncontrolled infection within 4 weeks of enrollment.
Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within 14 days prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study
Active clinically significant uncontrolled infection
Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
Serious active infection not controlled by antibiotics
Uncontrolled active infection;
Serious active infection
Presence of serious infection
Active infection.
Patients with an active infection
Subject must have a bloodstream infection with no other apparent source that is not related to an infection at another site that meets one of the following:
Subjects with bacteremia with documented microbiological evidence of another source of infection (eg, osteomyelitis, pneumonia, skin infection, urinary tract infection, joint infection, or abdominal infection) known to be due to the same organism cultured from the blood;
Presence of active infection
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Signs or symptoms of systemic systemic infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Signs or symptoms of systemic bacterial infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection)
Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals.
Known HIV infection or active infection with hepatitis B or C. Patients with unknown status at the time of enrollment must be tested during screening.
Subjects with uncontrolled, systematic infection should be excluded
Patients with an active or uncontrolled infection.
Subjects who have an uncontrolled infection are not eligible
Active pneumonitis or uncontrolled infection
No evidence of clinically significant active infection and no serious infection within the past month
Evidence of active infection, or serious infection within the past month
Uncontrolled infection
Serious, uncontrolled, concurrent infection(s)
Subjects with an active infection requiring antibiotics or at an increased risk of latent infection that may affect safe study participation
Patients who have an uncontrolled infection are not eligible
Active infection
Patient must not have an active, uncontrolled infection
Patients who have an active uncontrolled infection defined as: \r\n* Positive bacterial blood culture within 48 hours of study enrollment; \r\n* Fever above 38.2 degree Celsius (C) within 48 hours of study enrollment with clinical signs of infection; fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability\r\n* A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection\r\n* Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved; for patients with clostridium (c.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline\r\n* Active viral or protozoal infection requiring IV treatment
Active untreated infection
Patients who have an uncontrolled infection are not eligible
Active infection =< 5 days prior to registration
ARM A: Uncontrolled infection
ARM B: Uncontrolled infection
Active infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days)
Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
Patients with documented active, uncontrolled infection at the time of study entry
Active infection
Patients receiving any medications or substances to treat active infection
Uncontrolled active infection; patients with infection requiring parenteral antibiotics are eligible if the infection is controlled
Active infection-must be afebrile and off antibiotics
Active infection not adequately responding to appropriate therapy.
Uncontrolled infection
Patients with active infection are ineligible
Uncontrolled infection
Active infection =< 5 days prior to registration
Patients who have an active or uncontrolled infection are excluded
Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
Active uncontrolled infection
Ongoing infection > grade 2
Uncontrolled systemic illness, including but not limited to ongoing or active infection
Patients should not have any uncontrolled illness including ongoing or active infection
Active serious infection
Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
Patients with the presence of an active infection, abscess or fistula
Patients who have an uncontrolled infection are not eligible
Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study
Subject has active, uncontrolled infection
Active urinary tract infection
Patients should not have any uncontrolled illness including ongoing or active infection other than HIV
Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
Active infection: temperature > 100 Fahrenheit (F), fever of unknown origin, active symptoms or signs of infection as defined by the investigator
Any active infection not controlled by antibiotics
Patients who have an uncontrolled infection are not eligible
Patient may have no active uncontrollable systemic infection
Active ear/sinus infection
Patient has an uncontrolled illness including ongoing or active infection
Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
Evidence of ongoing, uncontrolled infection
Patients with active infection
Treatment with appropriate antiviral therapy for patients with active HBV infection is required
Patients who have an uncontrolled infection are not eligible
Patients with an active infection or with a fever >= 101.3 F within 3 days of the first scheduled day of protocol treatment
Patients with an uncontrolled serious infection
Presence of any serious or uncontrolled infection
Uncontrolled infection
Subjects with an active infection
Untreated systemic infection
Patients who have an uncontrolled infection are not eligible
Uncontrolled infection
Active infection that is not responding to antimicrobial therapy
Active uncontrolled infection
Hepatitis B or C infection (HBV), or untreated systemic infection
Subject has an active uncontrolled infection.
Presence of an active infection; patients with fever assessed to be \tumor fever\ but without active evidence of infection (e.g. blood cultures are negative) are eligible; in addition, patients who have an infection but without evidence of fever for 48 hours on antibiotics will be eligible
Patients with uncontrolled infection
Active infection not well controlled by antibacterial or antiviral therapy.
Patients must not have active, uncontrolled infection
Recent or ongoing serious infection, including:
Patients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient’s ability to participate in the protocol
Has dual active HBV infection and HCV infection at study entry.
Presence of active infection within 72 hours
Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection.
They have active diarhhea.
Active infection
Active infection
Active Grade 3 or higher infection.
Presence of any active or ongoing infection
Subject has active, uncontrolled infection
Active, unresolved infection
Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C
Have evidence of uncontrolled, active infection <7 days prior to administration of study medication.
Active infection or corneal ulcer (e.g., keratitis)
Patients should be free of active infection requiring antibiotics (with the exception of an uncomplicated urinary tract infection [UTI])
Uncontrolled infection
Evidence of active infection within 2 weeks prior to first dose of study treatment.
Patients with an active, uncontrolled systemic infection are not eligible until deemed controlled by the treating physician
Patients are ineligible if they have an active infection
Absence of uncontrolled infection
Uncontrolled infection
Recent or ongoing serious infection
Have an ongoing or active infection.
Ongoing or active infection;
Active infection;
Active infection or past hepatitis B or C infection
Presence of active serious infection;
Active infection not adequately responding to appropriate therapy.
Active or uncontrolled infection
Presence of an active uncontrolled infection.
Signs or symptoms of systemic bacterial infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection).
Serious active infection, or serious underlying medical condition.
Presence of active clinically serious infection
Urinary tract infection, including particularly bladder infection, must be resolved prior to being placed on study
Uncontrolled active infection
Uncontrolled active infection
Infection
Patients with active or uncontrolled systemic infection.
Patients with ongoing or active infection
Patients with active infections including uncontrolled human immunodeficiency virus (HIV) infection, active hepatitis B, C, or any other symptomatic systemic infection requiring active therapy will be excluded from study
Patients must not have uncontrolled infection
Patients with an active infection.
Clinical objective evidence of bacterial infection and a known site of infection.
Patients who have an uncontrolled infection are not eligible
Patients who have an uncontrolled infection are not eligible
Active life-threatening infection
Uncontrolled infection, fever > 100 degrees F; or antibiotic therapy < 72 hours prior to registration; or urinary tract infection < 72 hours prior to registration
Acute or chronic active hepatitis B or C infection, or other serious chronic infection requiring ongoing treatment
Any serious or uncontrolled medical disorder or active infection
Subject has an active uncontrolled infection. If an infection is present, the patient must be receiving definitive therapy and have no signs of progressing infection. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
Have active serious infection uncontrolled by antibiotics or antifungals
Free of active uncontrolled infection at the time of study entry
Current systemic infection or suspicion of active bacterial infection
Active, uncontrolled infection
Active infection that would impair the ability of the patient to receive study treatment
Ongoing or active infection; treatment with systemic antibiotics or antifungals for ongoing or recurrent infection (topical use of antibiotics or antifungals is allowed)
Active infection
Patient has an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment.
Active infection, including unexplained fever (temperature > 38.5 deg.C).
Patients must not have untreated or uncontrolled life-threatening infection
Uncontrolled infection within 14 days before study enrollment\r\n* Infection treated with appropriate antimicrobial therapy and without signs of progression/treatment failure does not constitute an exclusion criterion
Uncontrolled infection within 14 days prior to enrollment \r\n* Infection treated with appropriate antimicrobial therapy and without signs of progression/treatment failure does not constitute an exclusion criterion
Active infection or antibiotics within 48 hours prior to study
Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.
Serious, intercurrent illness including, but not limited to, clinically relevant active infection, known active hepatitis B or C viral infection, known human immunodeficiency virus (HIV) infection, uncontrolled diabetes mellitus, or serious co-morbid medical conditions such as chronic restrictive pulmonary disease, and cirrhosis
Active uncontrolled infection
Uncontrolled or current infection
Patients who have an uncontrolled infection, or who are currently receiving treatment for Clostridium (C) difficile infection
Uncontrolled active infection requiring parenteral antibiotics, antivirals or antifungals within 1 week prior to the first date of study treatment
Active (acute or chronic) or uncontrolled severe infection
Clinically significant comorbidities such as uncontrolled pulmonary disease, active central nervous system disease, active infection, serious infection within 14 days before the first dose of study drug, or any other condition that could compromise study participation by the participant.
Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study
Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose
Any uncontrolled active systemic infection.
Ongoing infection >= grade 2
Presence of active infection within 72 hours of treatment; patients with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not included on the list of prohibited medications
Subjects with active infection that requires parenteral antibiotics
Uncontrolled active infection within one week prior to first dose
Active infection that would impair the ability of the patient to receive study treatment
Subjects who have an uncontrolled infection
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1
Have an ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection.
Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose
Patients with serious, uncontrolled, concurrent infection(s)
Active and uncontrolled infection; patients with an active infection receiving treatment and hemodynamically stable for 48 hours may be entered into the study
Patients with uncontrolled infection are excluded
Active uncontrolled serious infection or sepsis at study enrollment
Serious, intercurrent illness including, but not limited to, clinically relevant active infection, known active hepatitis B or C viral infection, known human immunodeficiency virus (HIV) infection, uncontrolled diabetes mellitus, or serious co-morbid medical conditions such as chronic restrictive pulmonary disease, and cirrhosis
Subject has an active uncontrolled infection.
Co-infection of HBV and HCV
Active and uncontrolled disease (other than AML) or infection as judged by the treating physician
Evidence of active infection or serious infection (e.g., septic shock with multi-organ dysfunction) within the past month
Active unresolved infection
Patients should not have any uncontrolled illness including ongoing or active infection
Active uncontrolled serious infection or sepsis at study enrollment
Active and uncontrolled disease/infection as judged by the treating physician
Active Infection with HBV or HCV
Active, unresolved infection
Patients with any active, uncontrolled infection are NOT eligible for participation
Active opportunistic infection or treatment for opportunistic infection within four weeks of first day of study drug dosing
No evidence of active infection and no serious infection within the past month
Evidence of active infection, or serious infection within the past month
No evidence of active infection and no serious infection within the past month
Evidence of active infection, or serious infection within the past month
Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
Uncontrolled infection
Ongoing or active infection
Active dental infection
Patients who have an uncontrolled infection are not eligible
Uncontrolled active infection
Active or uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ?72 hrs.
Current evidence of invasive fungal infection (blood or tissue culture); patients with recent fungal infection must have a subsequent negative cultures to be eligible; known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values)
Uncontrolled infection
Active uncontrolled infection
Active life-threatening infection
No ongoing or active infection at study entry
Active serious infection
No previous evidence of opportunistic infection
Presence of uncontrolled infection
No active uncontrolled infection
Patients who have an uncontrolled or untreated infection are not eligible
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibiotics
Active infection or intercurrent illness
The patient has an uncontrolled infection, or is receiving anti-fungal treatment for an ongoing infection
No uncontrolled infection; protocol principal investigator (PI) or designee will be final arbiter if there is uncertainty regarding whether a previous infection is controlled on appropriate (antibiotic) therapy
Presence of uncontrolled infection
Presence of uncontrolled infection
Active, uncontrolled systemic infection
Active and uncontrolled disease/infection as judged by the treating physician
Active infection
Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
Ongoing or active infection
Uncontrolled inter-current illness including, but not limited to ongoing or active infection requiring intravenous antibiotics, ongoing immunosuppressive therapy (except for replacement steroids), active human immunodeficiency virus (HIV) infection, that might jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safety
Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
Patients must have an expected survival of > 60 days and must be free of active infection
Uncontrolled infection requiring ongoing antibiotics
Active infection, uncontrolled with intravenous antibiotics
Have ongoing or active infection
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1
Presence of uncontrolled infection
No evidence of acute infection
Patients who have uncontrolled active infection
The subject has uncontrolled, significant intercurrent or recent illness, including, but not limited to, an active or history of autoimmune disease or immune deficiency; idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV), AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).
Serious active infection or gastrointestinal disease
Active infection\r\n* Active infection includes patients with positive blood cultures
Active/chronic HBV or HCV infection;
Patients must not have untreated or uncontrolled life-threatening infection
Active untreated infection
Active infection at the start of lenalidomide
No untreated or uncontrolled life-threatening infection
Uncontrolled infection
Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
Active uncontrolled infection
No active infection
Active uncontrolled infection
active urinary tract infection;
Patients must have an expected survival of > 60 days and must be free of active infection
Active infection that is not responding to antimicrobial therapy
Uncontrolled active infection or illness
Patients with uncontrolled infection
Uncontrolled infection
Patients with an uncontrolled life-threatening infection
Patients with an active or uncontrolled infection.
Patients with active infection will not be eligible, but may become eligible once infection has resolved and they are at least 7 days from completion of antibiotics
Subjects with an active uncontrolled infection.
Evidence of ongoing active infection
Other active disease including but not limited to ulceration of the upper gastrointestinal tract, autoimmune disease, HIV infection, active HBV and HCV infection.
Uncontrolled infection
Active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or human immunodeficiency virus (HIV) infection
Evidence of an ongoing, uncontrolled systemic infection or an uncontrolled local infection requiring therapy at the time of start of study therapy
Active major systemic or local uncontrolled infection
Active infection
Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose
Known active uncontrolled systemic infection
Uncontrolled infection
Uncontrolled active infection
Active infection involving IV antibiotics within 2 weeks prior to C1D1
Active infection involving IV antibiotics within 2 weeks prior to C1D1
Uncontrolled infection
Any evidence of serious active infection.
Uncontrolled infection
Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study
Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
Prior systemic infection with BCG
No evidence of active infection and no serious infection within the past month
Evidence of active infection, or serious infection within the past month
Active and uncontrolled disease/infection as judged by the treating physician
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
Active, clinically serious infection greater than CTCAE grade 2. Patients may be eligible upon resolution of the infection.
Patients with uncontrolled infection or systemic disease
Presence of infection other than the infection of the bile duct (cholangitis)
Acute, active infection within 14 days of enrollment
Presence of uncontrolled infection
Uncontrolled opportunistic infection or treatment for opportunistic infection within 4 weeks of first day of study drug dosing
Have a significant uncontrolled infection active infection
The patient has an uncontrolled and active infection that would preclude study conduct and assessment
Presence of uncontrolled infection
Have significant, uncontrolled active infection
Patients with active lung infection or active pulmonary edema
Uncontrolled active infection
Patients with active, uncontrolled infection
Presence of uncontrolled infection.
Active infection within 14 days prior to scheduled treatment
Serious uncontrolled active infection
Patients should not have any evidence of active or uncontrolled infection requiring treatment with antibiotics
Known active meningeal infection
Serious, uncontrolled, concurrent infection(s)
Active uncontrolled infection
Uncontrolled or serious infection
Has an active, uncontrolled infection;
Presence of an active infection or fever >= 38.5 C within 3 days of the first scheduled protocol treatment
Active serious infection (pulmonary infiltrates or lesions are allowed only after the appropriate diagnostic testing is negative for infection or appropriate therapy was initiated for probable infection)
Concurrent, acute, active infection, or treatment for infection, other than oral thrush or genital herpes, within 14 days of enrollment
Patients with acute or chronic infection
Active or uncontrolled infection
Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
Has, at the planned initiation of study drug, an uncontrolled infection.
Active infection
No active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection)
History of HIV infection or acute or chronic active hepatitis B or C infection. Subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines
Active uncontrolled infection at time of enrollment or documented fungal infection within 3 months
Patients with active or uncontrolled systemic infection.
Uncontrolled infection within 4 weeks prior to randomization
Ongoing or active infection
Uncontrolled infection
Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
No active infection
Active infection including cytomegalovirus
Active, uncontrolled infection
Other significant active infection.
Uncontrolled, active infection; patients who are known to have HIV infection/ seropositivity, Hepatitis A, B, or C, or CMV reactivation
Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
Active untreated infection
Evidence of ongoing, uncontrolled systemic infection or an uncontrolled local infection requiring therapy at the start of study.
Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
Active AIDS / HIV infection, clinically uncontrolled immune deficiency disorders;
Active urinary tract infection
Any uncontrolled active systemic infection that requires treatment with intravenous (IV) antibiotics
Active uncontrolled infection
Presence of an infection that requires intravenous antibiotics
Infection:\r\n* Local infection at the puncture site\r\n* Systemic infection, osteomyelitis, discitis
Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study
Uncontrolled active infection; patients with infection requiring parenteral antibiotics are eligible if the infection is controlled
Active infection
Concurrent active infection
Active or uncontrolled infection. Patients with any infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ?72 hrs. Patients with fevers believed to be due to leukemia or MDS are eligible provided a thorough infection work-up is negative and the patient is clinically and hemodynamically stable.
Patients with active infection at time of biopsy
Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection.
Infection not controlled by antibiotics
Uncontrolled, active infection; patients who are known to have HIV infection/ seropositivity, Hepatitis A, B, or C, or CMV reactivation
Subject has an active uncontrolled infection
Active infection not controlled with appropriate antimicrobial therapy
No active infection
Patients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 1 week prior to first study drug administration.
Uncontrolled infection or systemic disease.
Other significant active infection.
Presence of uncontrolled infection
Active uncontrolled infection or severe infectious disease
Active uncontrolled infection;
Presence of active, uncontrolled infection.
Active infection.
Active uncontrolled infection or severe infectious disease
Severe or uncontrolled systemic infection
History of serious co-morbidity or uncontrolled illness that would preclude study therapy, such as active tuberculosis or any other active infection.
Patients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 2 weeks prior to first study drug administration.
Active uncontrolled opportunistic infection
Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
Known active infection.
Infection
Uncontrolled infection
Ongoing infection > grade 2
Active infection
Patients should not have any clinical evidence of an active infection at the time of enrollment
Active infection, ascites, hepatic encephalopathy
Any active or uncontrolled infection
Treatment with antibiotics for proven infection within 1 week prior to study entry or signs and symptoms consistent with an active infection or fever > 38.1 C.
Known active infection
Evidence of active infection
Presence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection including but not limited to: urinary tract infection, HIV, viral hepatitis
Infection
Has uncontrolled infection requiring systematic antibiotics
Presence of uncontrolled infection.
Infection
Have a chronic underlying infection
A serious active infection (> grade 2) within 7 days of enrollment
Serious, uncontrolled, concurrent infection(s)
Presence of active infection
Untreated bladder infection
Ongoing or active infection
Presence of uncontrolled infection
Currently active infection
Documented or suspected infection
Active infection that is not responding to antimicrobial therapy
Active infection
Serious active infection at the time of pre-study screening.
No serious, uncontrolled, concurrent infection(s)
Uncontrolled infection;
Active, uncontrolled infection
Have an uncontrolled infection
An uncontrolled infection
Active infection
Active or uncontrolled infection
Active or uncontrolled infection. Patients with any infection receiving treatment (antibiotic,antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ?72 hrs. Patients with fevers believed to be due to leukemia or MDS are eligible provided a thorough infection work-up is negative and the patient is clinically and hemodynamically stable.
Any clinically significant uncontrolled illness including ongoing active infection
Patients who have an uncontrolled infection are not eligible
Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study
Active infection with hepatitis A, B, or C; active infection is defined as serologic positivity and elevated liver function tests
Active infection
Have an active urinary tract infection (UTI),
Any evidence of serious active, uncontrolled infection (i.e., requiring an IV antibiotic or antiviral agent)
Active lung infection
Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
Ongoing or active infection.
Infection or abscess anywhere in the body
Active infection requiring systemic therapy, known human immunodeficiency virus infection, or positive test for hepatitis B active infection or hepatitis C active infection.
Subjects with an uncontrolled, active infection; subjects with viremia (cytomegalovirus or other) may be enrolled, provided they are on active therapy and at the discretion of the treating physician
EXCLUSION - STUDY 1: Active infection
Uncontrolled infection at initiation of protocol treatment
Current vaginal infection
Active and uncontrolled infection at the time of transplantation
Patients with documented infection at time of enrollment
Active Infection
Research participants having any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures, or radiological evidence of infections
Active cutaneous infection or inflammation
Uncontrolled intercurrent illness including, but not limited to, ongoing or active Clostridium difficile infection or history of Clostridium difficile infection
Patients must not have an active infection
Patients with uncontrolled infection at the time of study entry
Active infection or ulcer at the lumbar injection site
Active clinically significant uncontrolled infection
Serious, uncontrolled, concurrent infection(s)
Active or known prior infection at the pseudarthrosis site
Known active infection (excluding fungal infection of the nail beds) within 28 days prior to initiation of study drug that has not completely resolved
Any uncontrolled active systemic infection
Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to the first dose; active infection with concurrent treatment is acceptable only if the patient is clinically stable
Patient is known to have an uncontrolled active systemic infection
Active clinically significant uncontrolled infection
Active, uncontrolled infection
Active uncontrolled infection
Infection not controlled by antibiotics
Known current vaginal infection
Presence of an uncontrolled infection or infection that required intravenous treatment within 7 days of entry
Active/uncontrolled infection
Active, uncontrolled infection
Uncontrolled infection
Active, uncontrolled infection
Patients should not have any uncontrolled illness including ongoing or active infection
Active infection at time of transplantation (including active infection with aspergillus or other mold within 30 days)
Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
Presence of an active uncontrolled infection.
Active infection.
Active and uncontrolled infection
Active infection not controlled with appropriate antimicrobial therapy
Evidence of uncontrolled active infection
Active infection not controlled with appropriate antimicrobial therapy
An active infection or with a fever ? 38.5°C
Infection: patients with documented uncontrolled infection at the time of study entry are not eligible
Patient is receiving antibiotic therapy for an active infection
Subjects with any evidence of respiratory infection including any signs or symptoms of either a lower respiratory infection (LRI) or upper respiratory infection (URI)
Untreated active infection
Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
Active systemic infection or skin infection at or near the acupuncture sites
Infection: Patients who have an uncontrolled infection are not eligible until the infection is judged to be well controlled.
Known human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled.
Have active uncontrolled infection; an active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection; persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection
Presence of active infection within 72 hours
Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplant
Has an uncontrolled infection on the day of randomization
Clinically active infection; an active infection may alter the biodistribution of 18F-FLT
Uncontrolled infection
Evidence of active infection within 14 days of study enrollment
Ongoing systemic infection
Acute life threatening infection
Patients should not have any uncontrolled illness including ongoing or active infection
Patients should not have any uncontrolled illness including ongoing or active infection
No active skin infection
Patients must not have presence of uncontrolled infection
No concomitant infection or other serious major systemic illness
Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
Recognized concurrent active infection
Patient must not have an uncontrolled infection
Active infection
Infection is a common feature of AML; patients with active infection are permitted to enroll provided that the infection is controlled; patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control
Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to C1D1.
Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or tested positive for active hepatitis B or C infection
Any uncontrolled active systemic infection
Active infection
Patients that have recognized concurrent active infection
Active infection or chronic comorbidity that would interfere with therapy
Active infection
Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
Infection: Subjects with uncontrolled infection not eligible
Active, uncontrolled infection or severe infectious disease.
Active infection
Recent or ongoing serious infection.