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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022515-20 | EudraCT Number |
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This is a Phase 1/2 study evaluating the safety and anti-tumor activity of PD 0332991 in combination with Velcade® [bortezomib] and dexamethasone in patients who have received at least one previous treatment for multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Escalating doses of bortezomib will be administered intravenously on Days 8, 11, 15 and 18 of a 28-day cycle (Schedule A) or of a 21-day cycle (Schedule B). The planned doses to be evaluated are 0.7, 1 and 1.3 mg/m2 in combination with PD 0332991 and dexamethasone. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of PD-0332991: Phase 1 | MTD=highest dose level for which no more than 1 out of 6 participants experienced dose-limiting toxicity (DLT). DLT=any of the following treatment-related events: Absolute neutrophil count (ANC) less than (<)1000/microliter (mcL) (Grade 3 neutropenia) associated with documented infection/fever >=38.5degrees Celsius (C); Grade >=3 nonhematologic treatment-related toxicity, except those that were not maximally treated or considered tolerable, Grade 3 corrected QT interval (QTc) prolongation (QTc >500 millisecond [msec]) in asymptomatic participants even after repeat testing to exclude confounding factors and correction of reversible causes; Delay in the administration of Cycle 2 for more than 1 week of the planned date due to platelet count <25,000/mcL and/or ANC <500/mcL, or due to prolonged nonhematologic toxicities of Grade >=3; Inability to deliver at least 80 percent (%) of the planned PD 0332991 or bortezomib doses during Cycle 1 due to toxicity. | Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B |
| Recommended Phase II Dose (RP2D) of PD-0332991: Phase 1 | RP2D was determined based on the MTD, safety and tolerability profile of the study treatment. | Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B |
| Percentage of Participants With Objective Response (OR): Phase 2 | OR: confirmed stringent complete response(sCR),complete response(CR),very good partial response(VGPR) or partial response(PR) as per International Myeloma Working Group Uniform Response Criteria (IMWGURC). sCR: normal serum free light chain (FLC) ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, <5 percent (%) plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, >= 90% reduction in serum M-protein, <100 mg/24 hour (hr) urine M-protein. PR: >=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200 mg/24 hr, >=50% decrease in difference between involved and uninvolved FLC levels if serum, urine M-protein were unmeasurable, >= 50% reduction in plasma cells, provided baseline bone marrow plasma cell was >=30% if serum, urine M-protein were unmeasurable and serum free light assay was unmeasureable. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Screening in Phosphorylated Retinoblastoma (Rb), Tumor Biomarkers and Soluble Biomarkers Levels: Phase 1 | Screening, C1D1(baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medical Faculty Foundation | Chicago | Illinois | 60611 | United States | ||
| Northwestern Memorial Hospital/Main Labs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25813205 | Derived | Niesvizky R, Badros AZ, Costa LJ, Ely SA, Singhal SB, Stadtmauer EA, Haideri NA, Yacoub A, Hess G, Lentzsch S, Spicka I, Chanan-Khan AA, Raab MS, Tarantolo S, Vij R, Zonder JA, Huang X, Jayabalan D, Di Liberto M, Huang X, Jiang Y, Kim ST, Randolph S, Chen-Kiang S. Phase 1/2 study of cyclin-dependent kinase (CDK)4/6 inhibitor palbociclib (PD-0332991) with bortezomib and dexamethasone in relapsed/refractory multiple myeloma. Leuk Lymphoma. 2015;56(12):3320-8. doi: 10.3109/10428194.2015.1030641. Epub 2015 May 15. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A) | Palbociclib (PD 0332991) 100 milligram (mg) capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 milligram per square meter (mg/m^2) intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1 |
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| Dexamethasone | Drug | 20 mg, orally on Days 8, 11, 15 and 18 of a 28 day cycle (Schedule A) or of a 21-day cycle (Schedule B) in combination with PD 0332991 and bortezomib. |
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| PD 0332991 | Drug | Escalating doses of PD 0332991 will be administered orally on Days 1-21 of a 28-day cycle for Schedule A and on Days 1-12 of a 21-day cycle for Schedule B. The planned doses to be evaluated are 50, 75, 100 mg and 125 mg once daily in combination with bortezomib and dexamethasone. |
|
| Cycle 1 Day 1 (baseline) up to end of study (up to cycle 22 for schedule B) |
| Best Overall Response: Phase 1 |
Best overall response: best confirmed response on study after first study dose as per IMWGURC. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, >=90% reduction in serum M-protein, <100 mg/24 hr urine M-protein. PR: >=50% reduction of serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200mg/24 hr. Progressive disease (PD): >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. Stable disease (SD): criteria for CR, VGPR, PR or PD not met. |
| Cycle 1 Day 1 (baseline), assessed on Day 1 of every cycle up to end of study (up to Cycle 22 for schedule A and schedule B) |
| Time to Tumor Progression (TTP): Phase 2 | TTP was defined as the time from first dose of study medication to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per IMWGURC). PD: >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. | Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib |
| Progression-free Survival (PFS): Phase 2 | PFS was the time from start of study treatment to date progressive disease was documented or death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). PD: >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. | Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib |
| Duration of Objective Response (DR): Phase 2 | DR was defined as time from first documentation of objective tumor response (sCR, CR, VGPR or PR) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause since treatment started. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, >=90% reduction in serum M-protein, <100 mg/24hr urine M-protein. PR:>=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200 mg/24 hr. PD: >=25% increase from lowest response level in serum M-component, urine M-component, >=10% bone marrow plasma cell percentage, development of new bone lesions/soft tissue plasmacytomas/increase in size of existing bone lesions, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. | Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib |
| Overall Survival (OS): Phase 2 | OS was defined as the time from first dose of study medication to first documentation of death due to any cause. OS was calculated as (the death date or last known alive date [if death date unavailable] minus the date of first dose of study medication plus 1) divided by 30.44. | Cycle 1 Day 1 (baseline) up to end of study (up to Cycle 22 for schedule B), thereafter every 3 months until 1 year after the last dose of palbociclib |
| Number of Participants With Adverse Events (AEs) by Severity: Phase 2 | An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded according to the common terminology criteria for adverse events (CTCAE) criteria as 1=mild AE, 2=moderate AE, 3=severe AE, 4=life-threatening or disabling AE, 5=Death related to AE. The most severe grade was used in case of multiple occurrences of the same event. | Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Medication: Phase 2 | An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication until 28 days after the last dose of study medication that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study medication, which occurred during the trial. Treatment-related were adverse events (serious as well as non-serious adverse events) considered related to study medication by the investigator. Number of participants with treatment related TEAEs and all causality TEAEs were summarized. | Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib |
| Number of Participants With Laboratory Abnormalities: Phase 2 | Laboratory parameters included hematology (hemoglobin, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid); electrolytes (sodium, potassium, chloride, bicarbonate, calcium, magnesium and phosphate); urinalysis (protein and immunology [C reactive protein]), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported. | Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib |
| European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2 | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores for functional scales, global health status and symptom scales were calculated as an average of individual items, transformed to 0-100 scale; higher score=better level of functioning, health status or greater degree of symptoms. Score of the single items were transformed to 0-100 scale; higher score=greater degree of symptom/difficulty. | C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22) |
| Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2 | The QLQ-MY20 consisted of 20 items addressing 4 domains of health-related quality of life (HRQoL) important to participants with multiple myeloma: future perspective (2 items), pain/disease symptoms (6 items), social support /body image (2 items), and treatment side-effects (10 items). All items used 4 point scale (1 'Not at all' to 4 'Very much'). Scores for HRQoL domains were calculated as an average of the individual items, transformed to 0 to 100 range. Higher scores on symptom scales (disease symptoms and side effects of treatment) indicated a higher level of symptoms/problems. Higher scores on functional scales (future perspective and body image) indicated a higher level of QoL/functioning. | C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22) |
| Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2 | m-BPI-sf was a questionnaire designed to assess the severity of pain and the impact of pain on daily functions. m-BPI-sf contained questions that assessed pain severity (worst, least, average, right now) and pain interference (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each question was answered on a scale ranging from 0 "No pain" to 10 "Pain as bad as you can imagine". The 4 pain severity questions were averaged to derive an index of pain severity and the 7 function questions were averaged to derive an index for pain interference. Total score range for pain severity and interference indices: 0 to 10, where higher score indicated higher severity/interference. | C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22) |
| Chicago |
| Illinois |
| 60611 |
| United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Kansas Cancer Center and Medical Pavilion | Westwood | Kansas | 66205 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110-1093 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| New York Presbyterian, Weill Cornell Medical College | New York | New York | 10065 | United States |
| University of Pennsylvania Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | United States |
| Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vseobecna fakultni nemocnice v Praze | Prague | 12808 | Czechia |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik | Mainz | 55131 | Germany |
| FG001 | Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A) | Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
| FG002 | Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B) | Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
| FG003 | Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B) | Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
| FG004 | Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB) | Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
| COMPLETED |
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| NOT COMPLETED |
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| Phase 2 |
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Full analysis set (FAS) included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A) | Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
| BG001 | Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule B) | Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
| BG002 | Palbociclib + Bortezomib + Dexamethasone (Phase2:ScheduleB) | Included all participants who received palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||
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| Primary | Maximum Tolerated Dose (MTD) of PD-0332991: Phase 1 | MTD=highest dose level for which no more than 1 out of 6 participants experienced dose-limiting toxicity (DLT). DLT=any of the following treatment-related events: Absolute neutrophil count (ANC) less than (<)1000/microliter (mcL) (Grade 3 neutropenia) associated with documented infection/fever >=38.5degrees Celsius (C); Grade >=3 nonhematologic treatment-related toxicity, except those that were not maximally treated or considered tolerable, Grade 3 corrected QT interval (QTc) prolongation (QTc >500 millisecond [msec]) in asymptomatic participants even after repeat testing to exclude confounding factors and correction of reversible causes; Delay in the administration of Cycle 2 for more than 1 week of the planned date due to platelet count <25,000/mcL and/or ANC <500/mcL, or due to prolonged nonhematologic toxicities of Grade >=3; Inability to deliver at least 80 percent (%) of the planned PD 0332991 or bortezomib doses during Cycle 1 due to toxicity. | DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle. | Posted | Number | milligram (mg) | Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B |
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| Primary | Recommended Phase II Dose (RP2D) of PD-0332991: Phase 1 | RP2D was determined based on the MTD, safety and tolerability profile of the study treatment. | DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle. | Posted | Number | milligram (mg) | Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B |
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| Primary | Percentage of Participants With Objective Response (OR): Phase 2 | OR: confirmed stringent complete response(sCR),complete response(CR),very good partial response(VGPR) or partial response(PR) as per International Myeloma Working Group Uniform Response Criteria (IMWGURC). sCR: normal serum free light chain (FLC) ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, <5 percent (%) plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, >= 90% reduction in serum M-protein, <100 mg/24 hour (hr) urine M-protein. PR: >=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200 mg/24 hr, >=50% decrease in difference between involved and uninvolved FLC levels if serum, urine M-protein were unmeasurable, >= 50% reduction in plasma cells, provided baseline bone marrow plasma cell was >=30% if serum, urine M-protein were unmeasurable and serum free light assay was unmeasureable. | Primary response analysis set (PRAS) included first consecutive (by first treatment day) participants in response analysis set (RAS=included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 1 Day 1 (baseline) up to end of study (up to cycle 22 for schedule B) |
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| Secondary | Percent Change From Screening in Phosphorylated Retinoblastoma (Rb), Tumor Biomarkers and Soluble Biomarkers Levels: Phase 1 | Results are not reported because data was present as individual participant listings but not summarized for analysis, as per change in planned analysis. | Posted | Screening, C1D1(baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22) |
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| Secondary | Best Overall Response: Phase 1 | Best overall response: best confirmed response on study after first study dose as per IMWGURC. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, >=90% reduction in serum M-protein, <100 mg/24 hr urine M-protein. PR: >=50% reduction of serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200mg/24 hr. Progressive disease (PD): >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. Stable disease (SD): criteria for CR, VGPR, PR or PD not met. | RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease. | Posted | Number | participants | Cycle 1 Day 1 (baseline), assessed on Day 1 of every cycle up to end of study (up to Cycle 22 for schedule A and schedule B) |
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| Secondary | Time to Tumor Progression (TTP): Phase 2 | TTP was defined as the time from first dose of study medication to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per IMWGURC). PD: >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. | RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease. | Posted | Median | 95% Confidence Interval | months | Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib |
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| Secondary | Progression-free Survival (PFS): Phase 2 | PFS was the time from start of study treatment to date progressive disease was documented or death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). PD: >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. | RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease. | Posted | Median | 95% Confidence Interval | months | Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib |
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| Secondary | Duration of Objective Response (DR): Phase 2 | DR was defined as time from first documentation of objective tumor response (sCR, CR, VGPR or PR) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause since treatment started. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, >=90% reduction in serum M-protein, <100 mg/24hr urine M-protein. PR:>=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200 mg/24 hr. PD: >=25% increase from lowest response level in serum M-component, urine M-component, >=10% bone marrow plasma cell percentage, development of new bone lesions/soft tissue plasmacytomas/increase in size of existing bone lesions, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. | PRAS was defined as the first consecutive (by first treatment day) participants in RAS (RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable. DR was calculated for the subgroup of PRAS participants with objective response. | Posted | Median | 95% Confidence Interval | months | Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib |
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| Secondary | Overall Survival (OS): Phase 2 | OS was defined as the time from first dose of study medication to first documentation of death due to any cause. OS was calculated as (the death date or last known alive date [if death date unavailable] minus the date of first dose of study medication plus 1) divided by 30.44. | RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease. | Posted | Median | 95% Confidence Interval | months | Cycle 1 Day 1 (baseline) up to end of study (up to Cycle 22 for schedule B), thereafter every 3 months until 1 year after the last dose of palbociclib |
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| Secondary | Number of Participants With Adverse Events (AEs) by Severity: Phase 2 | An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded according to the common terminology criteria for adverse events (CTCAE) criteria as 1=mild AE, 2=moderate AE, 3=severe AE, 4=life-threatening or disabling AE, 5=Death related to AE. The most severe grade was used in case of multiple occurrences of the same event. | Safety analysis set (SAS) included all enrolled participants who received at least 1 dose of study treatment. | Posted | Number | participants | Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Medication: Phase 2 | An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication until 28 days after the last dose of study medication that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study medication, which occurred during the trial. Treatment-related were adverse events (serious as well as non-serious adverse events) considered related to study medication by the investigator. Number of participants with treatment related TEAEs and all causality TEAEs were summarized. | SAS included all enrolled participants who received at least 1 dose of study treatment. | Posted | Number | participants | Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib |
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| Secondary | Number of Participants With Laboratory Abnormalities: Phase 2 | Laboratory parameters included hematology (hemoglobin, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid); electrolytes (sodium, potassium, chloride, bicarbonate, calcium, magnesium and phosphate); urinalysis (protein and immunology [C reactive protein]), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported. | SAS included all enrolled participants who received at least 1 dose of study treatment. | Posted | Number | participants | Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib |
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| Secondary | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2 | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores for functional scales, global health status and symptom scales were calculated as an average of individual items, transformed to 0-100 scale; higher score=better level of functioning, health status or greater degree of symptoms. Score of the single items were transformed to 0-100 scale; higher score=greater degree of symptom/difficulty. | Patient Reported Outcomes (PRO) analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | 95% Confidence Interval | units on a scale | C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22) |
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| Secondary | Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2 | The QLQ-MY20 consisted of 20 items addressing 4 domains of health-related quality of life (HRQoL) important to participants with multiple myeloma: future perspective (2 items), pain/disease symptoms (6 items), social support /body image (2 items), and treatment side-effects (10 items). All items used 4 point scale (1 'Not at all' to 4 'Very much'). Scores for HRQoL domains were calculated as an average of the individual items, transformed to 0 to 100 range. Higher scores on symptom scales (disease symptoms and side effects of treatment) indicated a higher level of symptoms/problems. Higher scores on functional scales (future perspective and body image) indicated a higher level of QoL/functioning. | PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at spefied time points for each arm, respectively. | Posted | Mean | 95% Confidence Interval | units on a scale | C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22) |
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| Secondary | Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2 | m-BPI-sf was a questionnaire designed to assess the severity of pain and the impact of pain on daily functions. m-BPI-sf contained questions that assessed pain severity (worst, least, average, right now) and pain interference (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each question was answered on a scale ranging from 0 "No pain" to 10 "Pain as bad as you can imagine". The 4 pain severity questions were averaged to derive an index of pain severity and the 7 function questions were averaged to derive an index for pain interference. Total score range for pain severity and interference indices: 0 to 10, where higher score indicated higher severity/interference. | The PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment.'N' signifies those participants who were evaluable for this outcome measure and 'n' signifies participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | 95% Confidence Interval | units on a scale | C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22) |
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Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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 | Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A) | Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. | 0 | 3 | 3 | 3 | ||
| EG001 | Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A) | Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. | 3 | 6 | 6 | 6 | ||
| EG002 | Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B) | Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. | 0 | 7 | 7 | 7 | ||
| EG003 | Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B) | Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. | 5 | 5 | 5 | 5 | ||
| EG004 | Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB) | Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. | 10 | 30 | 30 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Central nervous system haemorrhage | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyperviscosity syndrome | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tongue coated | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood bicarbonate increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood bilirubin decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood chloride increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood creatinine decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Body height decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Overweight | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypogeusia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Walking aid user | Social circumstances | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Haemoglobinaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gingival inflammation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Palatal oedema | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tongue disorder | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Catheter site pruritus | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Spinal pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Meningitis pneumococcal | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Periorbital haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Clostridium test positive | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Granulocyte count decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| pH urine increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Anosmia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Monoplegia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Listless | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| C500026 | palbociclib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Global Deterioration of Health Status |
|
| Objective Progression or Relapse |
|
| Withdrawal by Subject |
|
| Other |
|
| Randomized but not Treated |
|
| 45 to 64 years |
|
| Greater than or equal to (>=) 65 years |
|
| Male |
|
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
|
|
|
|
Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
| OG002 | Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B) | Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
| OG003 | Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B) | Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
|
| OG001 | Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A) | Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
| OG002 | Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B) | Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
| OG003 | Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B) | Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent. |
|
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| Units | Counts |
|---|---|
| Participants |
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