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| ID | Type | Description | Link |
|---|---|---|---|
| KN 142 | Other Identifier | Merck & Co. |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in participants with NSCLC. Additionally, the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in participants with NSCLC, Melanoma, and Mismatch-Repair Proficient CRC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab | Experimental | Participants with NSCLC will receive entinostat 3 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
| Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab | Experimental | Participants with NSCLC will receive entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
| Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab | Experimental | Participants with NSCLC will receive entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
| Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab | Experimental | Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a programmed cell death receptor-1 (PD-1)- or programmed cell death ligand-1 (PD-L1)-blocking antibody, will receive entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| entinostat | Drug | An orally available histone deacetylases inhibitor (HDACs) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Objective Response Rate (ORR), as Assessed Using Immune Response RECIST (irRECIST) | The ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR). CR: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to <10 millimeters (mm). PR: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. For purposes of analysis, 1 month was considered to be 30.4375 days. | From date of randomization to date of progression (up to 765 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Clinical Benefit Rate (CBR), as Assessed Using irRECIST | The CBR was defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) lasting for at least 6 months. CR: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to <10 mm. PR: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. SD: Sum of the diameters (longest for nonnodal lesions, shortest for nodal lesions) of target and new measurable lesions neither CR, PR, (compared to baseline) or progressive disease (PD) (compared to nadir). |
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Inclusion Criteria:
Participants with NSCLC:
Has histologically- or pathologically-confirmed recurrent/metastatic NSCLC.
If has adenocarcinoma, required to have previously been tested for anaplastic lymphoma kinase (ALK) rearrangements and epidermal growth factor receptor (EGFR) mutations, with results available for collection in this study, and, if positive, has been treated with prior epidermal growth factor receptor (EGFR) or ALK therapy.
Received at least 1 chemotherapeutic regimen in the advanced/metastatic setting and experienced documented, unequivocal progressive disease by either RECIST 1.1 or clinical assessment. Additional requirements related to prior treatments applied and may have been dependent on mutational status.
Participants with NSCLC enrolled in Cohort 1 of the Expansion Phase should not have been previously treated with a PD-1/PD-L1-blocking antibody.
Participants in Expansion Phase, Cohorts 2 (NSCLC) and 3 (Melanoma):
Previously treated with a PD-1/PD-L1-blocking antibody and experienced documented, unequivocal radiographic progression of disease by irRECIST, or similar criteria during or within 12 weeks after last dose of such treatment. Participants must have received at least 6 weeks of PD-1/PD-L1 therapy for Cohort 2 and at least 8 weeks of PD-1/PD-L1 therapy for Cohort 3.
Participants with Melanoma:
In addition to having been previously treated with a PD-1/PD-L1-blocking antibody, has a histologically- or cytologically-confirmed diagnosis of unresectable or metastatic melanoma and experienced unequivocal progressive disease during treatment with a Serine/threonine-protein kinase B-Raf (BRAF) inhibitor if BRAF V600 mutation-positive. Treatment with BRAF inhibitor may occur after treatment with the checkpoint inhibitor.
Participants in Expansion Phase, Cohort 4 (CRC):
Received at least 1 chemotherapeutic regimen in the advanced/metastatic setting and experienced documented, unequivocal progressive disease by either RECIST 1.1 or clinical assessment. Must have documented mismatch repair-proficient colon cancer as determined by either immunohistochemistry for mismatch repair proteins or polymerase chain reaction (PCR)-based functional microsatellite instability. Participants with CRC enrolled in Cohort 4 should not have been previously treated with a PD-1/PD-L1-blocking antibody (that is, pembrolizumab, nivolumab, MEDI4736, or GNE PDL1 [MPDL3280A]).
All Participants:
Aged 18 years or older on the day written informed consent is given.
If has brain metastases, must have stable neurologic status following local therapy for at least 4 weeks without the use of steroids or on stable or decreasing dose of ≤10 milligrams (mg) daily prednisone (or equivalent), and must be without neurologic dysfunction that would confound the evaluation of neurologic and other AEs.
Evidence of locally recurrent or metastatic disease based on imaging studies within 28 days before the first study drug dose:
If receiving radiation therapy, has a 2-week washout period following completion of the treatment prior to receiving the first study drug dose and continues to have at least 1 measurable lesion, per above criterion.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Has acceptable renal and hepatic function and stable hematologic and coagulation status.
Female participants must not be pregnant. If a participants is of childbearing potential, the participant must agree to use effective contraception, as defined in the protocol, during the study and for 120 days after the last dose of study drug.
If male, agrees to use an adequate method of contraception starting from the first dose of study drug through 120 days after the last dose of study drug.
Experienced resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If participant underwent major surgery or radiation therapy of >30 gray (Gy), they must have recovered from the toxicity and/or complications from the intervention.
Willing to have fresh tumor samples collected during screening and at other time points designated as mandatory, per the Schedule of Study Assessments.
Able to understand and give written informed consent and comply with study procedures.
Exclusion Criteria:
Participants meeting any of the following criteria are not eligible for study participation:
Diagnosis of immunodeficiency or receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
Active autoimmune disease that has required systemic treatment in past 2 years (that is, with disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (for example, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
History of interstitial lung disease (ILD).
Allergy to benzamide or inactive components of entinostat.
History of allergies to any active or inactive ingredients of pembrolizumab or severe hypersensitivity (≥Grade 3) to pembrolizumab.
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to:
Note: Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging [using the identical imaging modality for each assessment, either MRI or CT scan] for at least 4 weeks prior to the first dose of study drug and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 2 weeks prior to the first dose of study drug or are on stable or decreasing dose of ≤10 mg daily prednisone (or equivalent). This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Received a live virus vaccination within 30 days of the first dose of treatment.
Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to baseline or who has not recovered (that is, ≤Grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier.
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study baseline or who has not recovered (that is, ≤Grade 1 or at baseline) from AEs due to a previously administered agent.
Note: Participants with ≤Grade 2 neuropathy or ≤Grade 2 alopecia are an exception to this criterion and may qualify for the study.
Note: If participant underwent major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte-colony stimulating factor [G-CSF], granulocyte macrophage-colony stimulating factor [GM-CSF], or recombinant erythropoietin) within 4 weeks prior to the first dose of study drug.
Currently receiving treatment with any other agent listed on the prohibited medication list such as valproic acid, or other systemic cancer agents within 14 days of the first dose of treatment.
If female, is pregnant, breastfeeding, or expecting to conceive, or if male, expect to father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.
Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
Known active hepatitis B (for example, hepatitis B surface antigen-reactive) or hepatitis C (for example, hepatitis C virus ribonucleic acid [qualitative]).
For CRC expansion cohort, no prior history of malignant bowel obstruction requiring hospitalization in the 6 months prior to enrollment
For the CRC expansion cohort, history of uncontrolled ascites, defined as symptomatic ascites and/or repeated paracenteses for symptom control in the past 3 months.
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| Name | Affiliation | Role |
|---|---|---|
| Pasi A Janne, MD, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06519 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2702835 | Background | Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9. | |
| 33203644 | Derived | Hellmann MD, Janne PA, Opyrchal M, Hafez N, Raez LE, Gabrilovich DI, Wang F, Trepel JB, Lee MJ, Yuno A, Lee S, Brouwer S, Sankoh S, Wang L, Tamang D, Schmidt EV, Meyers ML, Ramalingam SS, Shum E, Ordentlich P. Entinostat plus Pembrolizumab in Patients with Metastatic NSCLC Previously Treated with Anti-PD-(L)1 Therapy. Clin Cancer Res. 2021 Feb 15;27(4):1019-1028. doi: 10.1158/1078-0432.CCR-20-3305. Epub 2020 Nov 17. |
| Label | URL |
|---|---|
| CTCAE v. 4.03 | View source |
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Per protocol, 9 participants in the Confirmation Phase who rolled over to Cohort 2, and the other 7 participants who rolled over to Cohort 1 in the Expansion Phase, were counted in the Expansion Phase Population rather than in the Escalation/Confirmation Phase Population for the purpose of collecting data.
The study was conducted in 2 phases, a Dose Escalation/Confirmation Phase (Phase 1b) and an Expansion Phase (Phase 2).
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab | Participants with non-small cell lung cancer (NSCLC) received entinostat 3 milligrams (mg) administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose Escalation/Confirmation (Phase 1b) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 12, 2018 | Oct 7, 2024 |
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|
| Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab | Experimental | Participants with NSCLC (any histology) who has previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, will receive entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
| Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Experimental | Participants with melanoma who has previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, will receive entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
| Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Experimental | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
|
| pembrolizumab | Drug | A selective humanized monoclonal antibody (mAb) |
|
|
| 6 months |
| Phase 2: CBR, as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | The CBR was defined as the percentage of participants with a confirmed CR, PR, or SD lasting for at least 6 months. CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | 6 months |
| Phase 2: Progression Free Survival (PFS), as Assessed Using irRECIST | PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented. Number of participants without evidence of progression or death at Month 6 are reported. | 6 months |
| Phase 2: PFS, as Assessed Using RECIST 1.1 | PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm; the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. Number of participants without evidence of progression or death at Month 6 are reported. | 6 months |
| Phase 2: PFS Duration, as Determined by the Local Investigator Using irRECIST | PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented. For purposes of analysis, 1 month was considered to be 30.4375 days. | From date of randomization to PD or death due to any cause (up to 765 days) |
| Phase 2: PFS Duration, as Determined by the Local Investigator Using RECIST 1.1 | PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented. For purposes of analysis, 1 month was considered to be 30.4375 days. | From date of randomization to PD or death due to any cause (up to 765 days) |
| Phase 2: Overall Survival | Overall survival was defined as the number of months from randomization to the date of death (due to any cause). For purposes of analysis, 1 month was considered to be 30.4375 days. | From date of randomization to the date of death (up to 765 days) |
| Phase 2: Duration of Response, as Assessed Using irRECIST | Duration of response was defined as number of months from start date of CR or PR (whichever occurred first) and subsequently confirmed, to the first date that recurrent or progressive disease was documented. CR: Disappearance of all target lesions and any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR: At least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm; appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. For purposes of analysis, 1 month was considered to be 30.4375 days. | From start date of CR or PR to date of progression (up to 765 days) |
| Phase 2: Duration of Response, as Assessed Using RECIST 1.1 | Duration of response was defined as number of months from start date of CR or PR (whichever occurred first) and subsequently confirmed, to the first date that recurrent or progressive disease was documented. CR: Disappearance of all target lesions and any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR: At least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm; appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. For purposes of analysis, 1 month was considered to be 30.4375 days. | From start date of CR or PR to date of progression (up to 765 days) |
| Phase 2: Time to Response, as Assessed Using irRECIST | Time to response was defined as the number of months from the randomization date to the first date the participant achieved a PR or CR (whichever response occurred first and was subsequently confirmed). CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For purposes of analysis, 1 month was considered to be 30.4375 days. | From the date of randomization to date of PR or CR (up to 765 days) |
| Phase 2: Time to Response, as Assessed Using RECIST 1.1 | Time to response was defined as the number of months from the randomization date to the first date the participant achieved a PR or CR (whichever response occurred first and was subsequently confirmed). CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For purposes of analysis, 1 month was considered to be 30.4375 days. | From the date of randomization to date of PR or CR (up to 765 days) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs Resulting in the Permanent Discontinuation of Study Drug, and Death | An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that started on or after the first administration of study drug and within 30 days of the last administration of any study treatment. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. For purposes of analysis, 1 month was considered to be 30.4375 days. | From first dose of study drug up to 765 days |
| Phase 1b: Number of Participants With at Least One Dose Limiting Toxicities (DLTs) | A DLT was defined as the occurrence of any protocol-specified event in the first cycle of treatment (Day 1 through Day 21) of entinostat in combination with avelumab that were considered by the investigator to be at least possibly related to study drug. | Day 1 through Day 21 (Cycle 1) |
| Phase 1b: Recommended Phase 2 Dose (RP2D) | The RP2D was determined in discussion with the Sponsor, Medical Monitor, and Dose Determination Phase Investigators. Additionally, observations related to immune correlates, and any cumulative toxicity observed after multiple cycles might be included in the rationale supporting the RP2D. The RP2D could be equal to or less than the preliminary maximum tolerated dose (MTD). The MTD was defined as the highest dose level at which <33% of 6 participants experienced DLT. | Day 1 through Day 21 (Cycle 1) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Maryland, Marlene and Stewart Greenbaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| Dana Farber Cancer Institution | Boston | Massachusetts | 02215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| St Luke's University Health Network | Easton | Pennsylvania | 18045 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37230 | United States |
| FG001 |
| Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab |
Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| FG002 | Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| FG003 | Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a programmed cell death receptor-1 (PD-1)- or programmed cell death ligand-1 (PD-L1)-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| FG004 | Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| FG005 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| FG006 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with colorectal cancer (CRC) (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Expansion (Phase 2) |
|
|
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab | Participants with NSCLC received entinostat 3 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| BG001 | Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| BG002 | Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| BG003 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| BG004 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 2: Objective Response Rate (ORR), as Assessed Using Immune Response RECIST (irRECIST) | The ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR). CR: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to <10 millimeters (mm). PR: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. For purposes of analysis, 1 month was considered to be 30.4375 days. | Full analysis set (FAS) included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. | Posted | Number | 95% Confidence Interval | percentage of participants | From date of randomization to date of progression (up to 765 days) |
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|
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| Secondary | Phase 2: Clinical Benefit Rate (CBR), as Assessed Using irRECIST | The CBR was defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) lasting for at least 6 months. CR: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to <10 mm. PR: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. SD: Sum of the diameters (longest for nonnodal lesions, shortest for nodal lesions) of target and new measurable lesions neither CR, PR, (compared to baseline) or progressive disease (PD) (compared to nadir). | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Data were not censored for CBR analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| Secondary | Phase 2: CBR, as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | The CBR was defined as the percentage of participants with a confirmed CR, PR, or SD lasting for at least 6 months. CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Data were not censored for CBR analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| Secondary | Phase 2: Progression Free Survival (PFS), as Assessed Using irRECIST | PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented. Number of participants without evidence of progression or death at Month 6 are reported. | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Data were censored for PFS analysis based on prespecified analysis. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Phase 2: PFS, as Assessed Using RECIST 1.1 | PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm; the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. Number of participants without evidence of progression or death at Month 6 are reported. | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Data were censored for PFS analysis based on prespecified analysis. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Phase 2: PFS Duration, as Determined by the Local Investigator Using irRECIST | PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented. For purposes of analysis, 1 month was considered to be 30.4375 days. | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. | Posted | Median | 95% Confidence Interval | months | From date of randomization to PD or death due to any cause (up to 765 days) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: PFS Duration, as Determined by the Local Investigator Using RECIST 1.1 | PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented. For purposes of analysis, 1 month was considered to be 30.4375 days. | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. | Posted | Median | 95% Confidence Interval | months | From date of randomization to PD or death due to any cause (up to 765 days) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Overall Survival | Overall survival was defined as the number of months from randomization to the date of death (due to any cause). For purposes of analysis, 1 month was considered to be 30.4375 days. | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. | Posted | Median | 95% Confidence Interval | months | From date of randomization to the date of death (up to 765 days) |
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| Secondary | Phase 2: Duration of Response, as Assessed Using irRECIST | Duration of response was defined as number of months from start date of CR or PR (whichever occurred first) and subsequently confirmed, to the first date that recurrent or progressive disease was documented. CR: Disappearance of all target lesions and any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR: At least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm; appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. For purposes of analysis, 1 month was considered to be 30.4375 days. | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Here, 'Overall number of participants analyzed' = participants who achieved objective response. | Posted | Median | 95% Confidence Interval | months | From start date of CR or PR to date of progression (up to 765 days) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Duration of Response, as Assessed Using RECIST 1.1 | Duration of response was defined as number of months from start date of CR or PR (whichever occurred first) and subsequently confirmed, to the first date that recurrent or progressive disease was documented. CR: Disappearance of all target lesions and any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR: At least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm; appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. For purposes of analysis, 1 month was considered to be 30.4375 days. | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Here, 'Overall number of participants analyzed' = participants who achieved objective response. | Posted | Median | 95% Confidence Interval | months | From start date of CR or PR to date of progression (up to 765 days) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Time to Response, as Assessed Using irRECIST | Time to response was defined as the number of months from the randomization date to the first date the participant achieved a PR or CR (whichever response occurred first and was subsequently confirmed). CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For purposes of analysis, 1 month was considered to be 30.4375 days. | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Here, 'Overall number of participants analyzed' = participants who achieved objective response. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to date of PR or CR (up to 765 days) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Time to Response, as Assessed Using RECIST 1.1 | Time to response was defined as the number of months from the randomization date to the first date the participant achieved a PR or CR (whichever response occurred first and was subsequently confirmed). CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For purposes of analysis, 1 month was considered to be 30.4375 days. | FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Here, 'Overall number of participants analyzed' = participants who achieved objective response. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to date of PR or CR (up to 765 days) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs Resulting in the Permanent Discontinuation of Study Drug, and Death | An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that started on or after the first administration of study drug and within 30 days of the last administration of any study treatment. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. For purposes of analysis, 1 month was considered to be 30.4375 days. | Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab. | Posted | Count of Participants | Participants | From first dose of study drug up to 765 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1b: Number of Participants With at Least One Dose Limiting Toxicities (DLTs) | A DLT was defined as the occurrence of any protocol-specified event in the first cycle of treatment (Day 1 through Day 21) of entinostat in combination with avelumab that were considered by the investigator to be at least possibly related to study drug. | Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab. | Posted | Count of Participants | Participants | Day 1 through Day 21 (Cycle 1) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1b: Recommended Phase 2 Dose (RP2D) | The RP2D was determined in discussion with the Sponsor, Medical Monitor, and Dose Determination Phase Investigators. Additionally, observations related to immune correlates, and any cumulative toxicity observed after multiple cycles might be included in the rationale supporting the RP2D. The RP2D could be equal to or less than the preliminary maximum tolerated dose (MTD). The MTD was defined as the highest dose level at which <33% of 6 participants experienced DLT. | Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab. | Posted | Number | mg | Day 1 through Day 21 (Cycle 1) |
|
|
From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab | Participants with NSCLC received entinostat 3 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). | 6 | 6 | 4 | 6 | 6 | 6 |
| EG001 | Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). | 0 | 7 | 4 | 7 | 7 | 7 |
| EG002 | Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). | 1 | 9 | 2 | 9 | 9 | 9 |
| EG003 | Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). | 8 | 18 | 10 | 18 | 18 | 18 |
| EG004 | Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). | 41 | 76 | 33 | 76 | 75 | 76 |
| EG005 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mgvia IV infusion once every 3 weeks (Day 1 of each 21-day cycle). | 31 | 53 | 24 | 53 | 52 | 53 |
| EG006 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). | 25 | 38 | 14 | 38 | 37 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Brain mass | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Steatohepatitis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Spinal cord injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypercalcaemia of malignancy | Endocrine disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Tenderness | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Early satiety | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Induration | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Infusion site bruising | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oedema mouth | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Reactive gastropathy | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Electrocardiogram QT interval | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Antineutrophil cytoplasmic antibody decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Carbon dioxide increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Differential white blood cell count abnormal | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Platelet count | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Thyroxine free increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Tri-iodothyronine decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthralgia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myalgia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain in extremity | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscular weakness | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscle spasms | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neck pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Groin pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Flank pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Joint swelling | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bone pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscle atrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain in jaw | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Limb discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscle twitching | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal stiffness | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myopathy | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myositis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neck mass | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Osteonecrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Soft tissue disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Spinal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Orthostatic intolerance | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Visual field defect | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin odour abnormal | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Fungal oesophagitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Penetrating atherosclerotic ulcer | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Poor venous access | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Tracheal haemorrhage | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Eyelid function disorder | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Inner ear disorder | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bone cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vaginal lesion | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Autoimmune disorder | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Steatohepatitis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Infection prophylaxis | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
| |
| Sinus operation | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
| |
| Wound drainage | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
Publication of the results of the multi-center Study shall not be made before the first multi-site publication by Sponsor or Publications Committee. No Public Presentation by Institution or Investigator will be made until Study Documentation/Results from all sites are received and analyzed by Sponsor. Separate publication by Investigator will be delayed for a period of 18 months until the initial publication by Committee or Sponsor, or a determination is made not to make such publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate Madigan, MD, Chief Medical Officer | Syndax Pharmaceuticals, Inc. | 858-888-3798 | kmadigan@syndax.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 26, 2019 | Oct 7, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C118739 | entinostat |
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| 45 to 64 years |
|
| 65 to 74 years |
|
| 75 years and older |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
| OG002 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG003 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 500 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
|
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG002 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG003 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
|
| OG002 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG003 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
|
| OG002 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG003 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
|
| OG002 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG003 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
|
| OG002 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG003 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
|
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG003 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
|
| OG001 | Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG002 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG003 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
|
| OG001 | Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG002 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG003 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
|
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG002 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG003 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
|
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG002 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG003 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
|
| OG001 |
| Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab |
Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG002 | Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG003 | Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG004 | Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab | Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG005 | Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab | Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
| OG006 | Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab | Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle). |
|
|
Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|
|